NCT05549505
Version 8 to 9 · Arvinas Inc.
Patch inspector
Manual review pending.
arms_or_interventions_changeeligibility_criteria_change [
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Percent Reduction in Ki-67 Expression From Baseline to Day 15 in Tumor Biopsies
/protocolSection/outcomesModule/primaryOutcomes/0/description primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority. Percent change in Ki-67 expression between baseline and C1D15 tumor biopsies
Tumor biopsy Ki-67 expression (% of tumor cells that are positive for Ki-67) at baseline and Cycle 1 Day 15 (C1D15) was collected. Ki-67 expression was assessed by immunohistochemical staining in a central laboratory. The log-transformed Ki-67 after approximately 2 weeks of treatment as a percentage of the baseline value, ie, the ratio between the Ki-67 measurements obtained from C1D15 visit and baseline was modelled using a generalized linear model (GLM) with both stratification factors (ie, baseline Ki-67 score and the tumor size) and treatment as co-variates. The treatment effects were back transformed into geometric means and their Confidence Intervals. The percent change, in other words, relative reduction, of Ki-67 after 2 weeks of treatment is reported as the complement of the ratio between the Ki-67 measurement from C1D15 and baseline, that is 100% × (1-Ki-67 from C1D15/Ki-67 from baseline).
/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority. 2 weeks
Baseline (during screening, prior to Day 1) and Day 15
/protocolSection/armsInterventionsModule/armGroups/0/label arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure. ARV-471 monotherapy
Arm A: ARV-471 (Experimental)
/protocolSection/armsInterventionsModule/armGroups/0/description arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure. ARV-471 taken once daily until surgical resection
Participants received 200 mg ARV-471 (2*100 mg tablets) once daily for approximately 5.5 months prior to undergoing surgical resection (no later than Cycle 6 Day 18 [C6D18] + 14 days).
/protocolSection/armsInterventionsModule/armGroups/1/label arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure. Anastrozole monotherapy
Arm B: Anastrozole
/protocolSection/armsInterventionsModule/armGroups/1/description arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure. Anastrozole 1mg taken once daily until surgical resection
Participants received 1 mg Anastrozole tablet orally once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days).
/protocolSection/armsInterventionsModule/interventions/0/description arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure. tablets
100 mg tablet
/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0 arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure. ARV-471 monotherapy
Arm A: ARV-471 (Experimental)
/protocolSection/armsInterventionsModule/interventions/0/otherNames arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure. [ "Vepdegestrant", "PF-07850327" ]
/protocolSection/armsInterventionsModule/interventions/1/description arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure. 1mg tablet
1 mg tablet
/protocolSection/armsInterventionsModule/interventions/1/armGroupLabels/0 arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure. Anastrozole monotherapy
Arm B: Anastrozole
/protocolSection/armsInterventionsModule/interventions/2/description arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure. Participants will have surgical resection approximately 5.5 months after starting treatment (C6D18 ± 14 days)
Surgical resection approximately 5.5 months after starting treatment (C6D18 ± 14 days)
/protocolSection/armsInterventionsModule/interventions/2/armGroupLabels/0 arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure. ARV-471 monotherapy
Arm A: ARV-471 (Experimental)
/protocolSection/armsInterventionsModule/interventions/2/armGroupLabels/1 arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure. Anastrozole monotherapy
Arm B: Anastrozole
/protocolSection/eligibilityModule/eligibilityCriteria eligibility_criteria_change Eligibility criteria changes can alter the studied population. <p>Inclusion Criteria:</p><ul><li>Post-menopausal females ≥ 18 years</li><li><p>Histologically or cytologically confirmed ER+ and HER2- breast cancer (per local assessment). ER and HER2 status must be documented:</p><ul><li>ER+ disease, with ER staining of ≥ 10% of tumor cell nuclei by IHC per ASCO/CAP Guidelines (Allison 2020).</li><li>HER2- disease by either IHC or in situ hybridization per ASCO/CAP guidelines</li><li>Ki-67 score ≥ 5%, analyzed locally</li></ul></li><li>Clinical T1c-T4c, N0-N2, M0 breast cancer amenable to definitive surgical resection, without bilateral breast ductal carcinoma in situ or invasive breast cancer</li><li>The primary tumor must be at least 1.5 cm by imaging</li><li>ECOG performance status of 0 or 1 Willingness to undergo a screening biopsy, an on-treatment biopsy and surgical resection</li></ul><p>Exclusion Criteria:</p><ul><li>Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or cervical carcinoma in situ</li><li>Any of the following in the previous 6 months: Myocardial infarction; Severe unstable angina; Coronary/peripheral artery bypass graft; Symptomatic congestive heart failure (New York Heart Association class III or IV); Cerebrovascular accident; Transient ischemic attack; Symptomatic pulmonary embolism or other clinically significant episode of thromboembolism</li><li>Any of the following in the previous 6 months: Congenital long QT syndrome; Torsade de Pointes; Sustained ventricular tachyarrhythmia and ventricular fibrillation; Left anterior hemiblock (bifascicular block); Ongoing cardiac dysrhythmias of NCI CTCAE ≥ Grade 2; Atrial fibrillation of any grade (≥ Grade 2 in the case of asymptomatic lone atrial fibrillation)</li><li>QTcF > 470 msec</li><li>Active, uncontrolled bacterial, fungal or viral infection, including HBV, HCV, and HIV or AIDS-related illness</li><li>Active inflammatory gastrointestinal disease, chronic diarrhea, known uncontrolled diverticular disease, or previous gastric resection or lap band surgery</li><li>Cirrhosis meeting criteria for Child Pugh B and C</li><li>Prior treatment for breast cancer including systemic therapy (eg, chemotherapy, hormonal therapy), radiation, surgery, or any investigational agents</li><li>Any live vaccines within 14 days of planned start of first dose of study drug.</li><li>Major surgery (as defined by the Investigator) within four weeks of first dose of study drug</li></ul>
<p>Inclusion Criteria:</p><ul><li>Post-menopausal females ≥ 18 years.</li><li><p>Histologically or cytologically confirmed ER+ and HER2- breast cancer (per local assessment). ER and HER2 status must be documented:</p><ul><li>ER+ disease, with ER staining of ≥ 10% of tumor cell nuclei by immunohistochemistry (IHC) per American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines.</li><li>HER2- disease by either IHC or in situ hybridization per ASCO/CAP guidelines.</li><li>Ki-67 score ≥ 5%, analyzed locally.</li></ul></li><li>Clinical T1c-T4c, N0-N2, M0 breast cancer amenable to definitive surgical resection, without bilateral breast ductal carcinoma in situ or invasive breast cancer.</li><li>The primary tumor must be at least 1.5 cm by imaging.</li><li>Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.</li><li>Willingness to undergo a screening biopsy, an on-treatment biopsy and surgical resection.</li></ul><p>Exclusion Criteria:</p><ul><li>Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or cervical carcinoma in situ.</li><li>Any of the following in the previous 6 months: Myocardial infarction; Severe unstable angina; Coronary/peripheral artery bypass graft; Symptomatic congestive heart failure (New York Heart Association class III or IV); Cerebrovascular accident; Transient ischemic attack; Symptomatic pulmonary embolism or other clinically significant episode of thromboembolism.</li><li>Any of the following in the previous 6 months: Congenital long QT syndrome; Torsade de Pointes; Sustained ventricular tachyarrhythmia and ventricular fibrillation; Left anterior hemiblock (bifascicular block); Ongoing cardiac dysrhythmias of NCI CTCAE ≥ Grade 2; Atrial fibrillation of any grade (≥ Grade 2 in the case of asymptomatic lone atrial fibrillation).</li><li>corrected QT (Fridericia method) (QTcF) > 470 msec.</li><li>Active, uncontrolled bacterial, fungal or viral infection, including (but not limited to) hepatitis B virus (HBV), hepatitis C virus (HCV), and known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.</li><li>Active inflammatory gastrointestinal disease, chronic diarrhea, known uncontrolled diverticular disease, or previous gastric resection or lap band surgery.</li><li>Cirrhosis meeting criteria for Child Pugh B and C.</li><li>Prior treatment for breast cancer including systemic therapy (eg, chemotherapy, hormonal therapy), radiation, surgery, or any investigational agents.</li><li>Any live vaccines within 14 days of planned start of first dose of study drug.</li><li>Major surgery (as defined by the Investigator) within four weeks of first dose of study drug.</li></ul>
/protocolSection/outcomesModule/secondaryOutcomes/0/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Evaluate the safety/tolerability of ARV-471 and anastrozole, respectively
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Study Drug Discontinuation
/protocolSection/outcomesModule/secondaryOutcomes/0/description secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Incidence of all adverse events, serious adverse events, and adverse events leading to study drug discontinuation
An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. A TEAE is an AE that emerges or worsens on/after the first dose of ARV-471/Anastrozole to 30 days after the last administration of the study intervention (ie, study drug treatment or surgical resection, whichever occurs last).
/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. From signing of consent to minimum of 30 days after last administration of study drug
From signing of consent to minimum of 30 days after last administration of study drug (up to approximately 6.5 months)
/protocolSection/outcomesModule/secondaryOutcomes/1/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Evaluate the pathological response of ARV-471 and anastrozole, respectively (pathologic stage)
Pathologic Stage at the Time of Surgical Resection
/protocolSection/outcomesModule/secondaryOutcomes/1/description secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Pathologic stage at the time of surgical resection
<p>Local pathological assessment of the tissue from surgical resection (performed after approximately 5.5 months of treatment), at minimum, included pathologic stage (ypT and ypN stage) as described in the Statistical Analysis Plan (SAP). The number of participants with the following disease staging at post-surgery are summarized:</p><p>Pathologic Tumor - ypT (ypTx, ypT0, ypTis, ypT1mi, ypT1a, ypT1b, ypT1c, ypT2, ypT3, ypT4a, ypT4b, ypT4c) Pathological Lymph Nodes - ypN (ypNX, ypN0, ypN0[i+], ypN0[mol+], ypN1, ypN1mi, ypN1a, ypN1b, ypN1c, ypN2, ypN2a, ypN2b, ypN3, ypN3a, ypN3b, ypN3c).</p>
/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Approximately 5.5 months
At Cycle 6 Day 18 (approximately 5.5 months), each cycle is 28 days
/protocolSection/outcomesModule/secondaryOutcomes/1/reviewUnit secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. {
"resetReasons": [
"The description of the scale or categories does not include sufficient information to understand the results reported."
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} /protocolSection/outcomesModule/secondaryOutcomes/2/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Evaluate the pathological response of ARV-471 and anastrozole, respectively (pathologic complete response rate)
Pathological Complete Response(pCR) Rate at the Time of Surgical Resection
/protocolSection/outcomesModule/secondaryOutcomes/2/description secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. pathologic complete response rate at the time of surgical resection
pCR is defined as no invasive cancer in the breast and sampled axillary lymph nodes following completion of neoadjuvant systemic therapy (ie, Pathologic Tumor - ypT = ypT0 or ypTis, and Pathologic Lymph Nodes - ypN = ypN0 in the current American Joint Committee on Cancer (AJCC) staging system). pCR rate is the percentage of participants with pCR.
/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Approximately 5.5 months
At Cycle 6 Day 18 (approximately 5.5 months), each cycle is 28 days
/protocolSection/outcomesModule/secondaryOutcomes/3/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Evaluate the pathological response of ARV-471 and anastrozole, respectively (modified Pre-operative Endocrine Prognostic Index score)
Number of Participants With Modified Preoperative Endocrine Prognostic Index (mPEPI) Score of 0 at the Time of Surgical Resection
/protocolSection/outcomesModule/secondaryOutcomes/3/description secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. modified Pre-operative Endocrine Prognostic Index score at the time of surgical resection
mPEPI score was derived from factors assigned a numerical score following Neoadjuvant endocrine treatment (NET). Total mPEPI score assigned to each patient was the sum of the risk points derived from the pathological (pT) stage, lymph node (pN) stage and Ki67 level. Number of participants with score 0 was reported. Participants with mPEPI score of 0 have pathological stage pT1 or pT2, negative lymph nodes pN0 and proliferation index [Ki-67] of less than or equal to 2.7%.
/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Approximately 5.5 months
At Cycle 6 Day 18 (approximately 5.5 months), each cycle is 28 days
/protocolSection/outcomesModule/secondaryOutcomes/4/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Evaluate the clinical response of ARV-471 and anastrozole, respectively (breast conserving surgery rate)
Breast Conserving Surgery (BCS) Rate
/protocolSection/outcomesModule/secondaryOutcomes/4/description secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. rates of breast conserving surgery
Breast conserving surgery (BCS) Rate is the percentage of participants received breast conserving surgery.
/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Approximately 5.5 months
At Cycle 6 (from Day 141 to Day 168), each cycle is 28 days
/protocolSection/outcomesModule/secondaryOutcomes/5/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Evaluate the clinical response of ARV-471 and anastrozole, respectively (radiographic response)
Radiographic Response Per Modified Response Evaluation Criteria in Solid Tumors (mRECIST) in Primary Tumor During Cycle 6
/protocolSection/outcomesModule/secondaryOutcomes/5/description secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. radiographical response rate in the primary tumor during cycle 6
The number of participants with Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD), Not Evaluable (NE) per mRECIST calculated. CR = disappearance of all target lesions, PR is >=30% decrease in sum of diameters of target lesions, progressive disease (PD) is >=20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions.
/protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Approximately 5 months
At Cycle 6 (from Day 141 to Day 168), each cycle is 28 days
/protocolSection/outcomesModule/secondaryOutcomes/6/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Evaluate the clinical response of ARV-471 and anastrozole, respectively (caliper-based response)
Percentage Change From Baseline at Cycle 6 Day 1 in Caliper Measurement of the Primary Tumor
/protocolSection/outcomesModule/secondaryOutcomes/6/description secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Best percentage change from baseline up to C6D1 in caliper measurement of the primary tumor
The percentage change from the baseline of the primary breast tumor size in physical exam calculated in caliper measurement. Caliper-based response is the maximum percentage decrease or minimum percentage increase if there is no decrease per participant.
/protocolSection/outcomesModule/secondaryOutcomes/6/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Approximately 5 months
Baseline (Day 1) and Cycle 6 Day 1 (At Day 141), each cycle is 28 days
/protocolSection/statusModule/statusVerifiedDate 2024-08
2025-07
/protocolSection/statusModule/lastUpdateSubmitDate 2024-08-29
2025-07-04
/protocolSection/statusModule/lastUpdatePostDateStruct/date 2024-09-03
2025-07-24
/protocolSection/statusModule/resultsFirstSubmitDate 2025-07-04
/protocolSection/descriptionModule/briefSummary This trial is a Phase 2 neoadjuvant study evaluating ARV-471 or anastrozole in post-menopausal women with ER+/HER2- localized breast cancer.
This trial is a Phase 2 neoadjuvant study evaluating ARV-471 or anastrozole in post-menopausal women with estrogen receptor positive/ human epidermal growth factor receptor 2 (ER+/HER2)- localized breast cancer.
/protocolSection/conditionsModule/keywords/12 human epidermal growth factor receptor 2
human epidermal growth factor receptor 2 negative
/protocolSection/conditionsModule/keywords/19 PF-07850327
/hasResults false
true
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"moreInfoModule": {
"pointOfContact": {
"email": "clinicaltrialsARV-471@arvinas.com",
"phone": "475-345-3366",
"title": "Arvinas Estrogen Receptor, Inc.",
"organization": "Arvinas Estrogen Receptor, Inc"
},
"certainAgreement": {
"piSponsorEmployee": false,
"restrictiveAgreement": true
}
},
"adverseEventsModule": {
"timeFrame": "From first study drug administration up to approximately 6.5 months.",
"description": "Safety Analysis Set consisting of all enrolled participants who received at least 1 dose of study intervention.\nFor All-Cause Mortality, Full Analysis Set was used which included all the enrolled participants who were randomized.",
"eventGroups": [
{
"id": "EG000",
"title": "Arm A: ARV-471 (Experimental)",
"description": "Participants received 200 mg ARV-471 (2*100 mg tablets) once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days).",
"otherNumAtRisk": 101,
"deathsNumAtRisk": 102,
"otherNumAffected": 72,
"seriousNumAtRisk": 101,
"deathsNumAffected": 0,
"seriousNumAffected": 4
},
{
"id": "EG001",
"title": "Arm B: Anastrozole",
"description": "Participants received 1 mg Anastrozole tablet orally once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days).",
"otherNumAtRisk": 48,
"deathsNumAtRisk": 50,
"otherNumAffected": 32,
"seriousNumAtRisk": 48,
"deathsNumAffected": 0,
"seriousNumAffected": 5
}
],
"otherEvents": [
{
"term": "Anaemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 3,
"numAffected": 3
}
],
"organSystem": "Blood and lymphatic system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "Vertigo",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 7,
"numAffected": 7
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Ear and labyrinth disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "Constipation",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 19,
"numAffected": 16
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 3,
"numAffected": 3
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "Nausea",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 16,
"numAffected": 15
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 2,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "Asthenia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 24,
"numAffected": 21
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 5,
"numAffected": 5
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "Fatigue",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 14,
"numAffected": 13
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 3,
"numAffected": 3
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "COVID-19",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 6,
"numAffected": 6
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "Nasopharyngitis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 4,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 3,
"numAffected": 3
}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "Urinary tract infection",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 10,
"numAffected": 8
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "Alanine aminotransferase increased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 6,
"numAffected": 6
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Investigations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "Decreased appetite",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 10,
"numAffected": 8
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "Arthralgia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 16,
"numAffected": 14
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 15,
"numAffected": 15
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "Dizziness",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 5,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 3,
"numAffected": 3
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "Headache",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 10,
"numAffected": 8
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "Insomnia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 10,
"numAffected": 9
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Psychiatric disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "Alopecia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 3,
"numAffected": 3
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "Hot flush",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 28,
"numAffected": 25
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 10,
"numAffected": 10
}
],
"organSystem": "Vascular disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "Hypertension",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 18,
"numAffected": 12
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 4,
"numAffected": 4
}
],
"organSystem": "Vascular disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
}
],
"seriousEvents": [
{
"term": "Angina pectoris",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "Cardiac arrest",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "Bacteraemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "COVID-19",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "Post procedural infection",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "Postoperative wound infection",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "Pyelonephritis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "Post procedural haematoma",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Injury, poisoning and procedural complications",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "Ataxia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "Encephalopathy",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "Mental status change",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Psychiatric disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
}
],
"frequencyThreshold": "5"
},
"outcomeMeasuresModule": {
"outcomeMeasures": [
{
"type": "PRIMARY",
"title": "Percent Reduction in Ki-67 Expression From Baseline to Day 15 in Tumor Biopsies",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "93",
"groupId": "OG000"
},
{
"value": "46",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm A: ARV-471 (Experimental)",
"description": "Participants received 200 mg ARV-471 (2*100 mg tablets) once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days)."
},
{
"id": "OG001",
"title": "Arm B: Anastrozole",
"description": "Participants received 1 mg Anastrozole tablet orally once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days)."
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "71.4",
"groupId": "OG000",
"lowerLimit": "60.6",
"upperLimit": "79.3"
},
{
"value": "72.9",
"groupId": "OG001",
"lowerLimit": "57.8",
"upperLimit": "82.6"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "Baseline (during screening, prior to Day 1) and Day 15",
"description": "Tumor biopsy Ki-67 expression (% of tumor cells that are positive for Ki-67) at baseline and Cycle 1 Day 15 (C1D15) was collected.\nKi-67 expression was assessed by immunohistochemical staining in a central laboratory.\nThe log-transformed Ki-67 after approximately 2 weeks of treatment as a percentage of the baseline value, ie, the ratio between the Ki-67 measurements obtained from C1D15 visit and baseline was modelled using a generalized linear model (GLM) with both stratification factors (ie, baseline Ki-67 score and the tumor size) and treatment as co-variates.\nThe treatment effects were back transformed into geometric means and their Confidence Intervals.\nThe percent change, in other words, relative reduction, of Ki-67 after 2 weeks of treatment is reported as the complement of the ratio between the Ki-67 measurement from C1D15 and baseline, that is 100% × (1-Ki-67 from C1D15/Ki-67 from baseline).",
"unitOfMeasure": "Percent reduction",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "Ki-67 Evaluable Set included all enrolled participants who were randomized and received at least one dose of study treatment and had evaluable central Ki-67 measurements other than '0' or '< 1' from baseline and evaluable Ki-67 measurements from C1D15 visits.",
"measureCategoriesReviewUnit": {
"resetReasons": [
"The Measure Type appears inaccurate."
]
}
},
{
"type": "SECONDARY",
"title": "Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Study Drug Discontinuation",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "101",
"groupId": "OG000"
},
{
"value": "48",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm A: ARV-471 (Experimental)",
"description": "Participants received 200 mg ARV-471 (2*100 mg tablets) once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days)."
},
{
"id": "OG001",
"title": "Arm B: Anastrozole",
"description": "Participants received 1 mg Anastrozole tablet orally once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days)."
}
],
"classes": [
{
"title": "TEAEs",
"categories": [
{
"measurements": [
{
"value": "82",
"groupId": "OG000"
},
{
"value": "37",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Serious TEAEs",
"categories": [
{
"measurements": [
{
"value": "4",
"groupId": "OG000"
},
{
"value": "5",
"groupId": "OG001"
}
]
}
]
},
{
"title": "TEAEs leading to study drug discontinuation",
"categories": [
{
"measurements": [
{
"value": "3",
"groupId": "OG000"
},
{
"value": "4",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"timeFrame": "From signing of consent to minimum of 30 days after last administration of study drug (up to approximately 6.5 months)",
"description": "An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.\nAn AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention.\nA serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important.\nA TEAE is an AE that emerges or worsens on/after the first dose of ARV-471/Anastrozole to 30 days after the last administration of the study intervention (ie, study drug treatment or surgical resection, whichever occurs last).",
"unitOfMeasure": "Participants",
"reportingStatus": "POSTED",
"populationDescription": "Safety Analysis Set which consisted of all enrolled participants who received at least 1 dose of study intervention."
},
{
"type": "SECONDARY",
"title": "Pathologic Stage at the Time of Surgical Resection",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "102",
"groupId": "OG000"
},
{
"value": "50",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm A: ARV-471 (Experimental)",
"description": "Participants received 200 mg ARV-471 (2*100 mg tablets) once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days)."
},
{
"id": "OG001",
"title": "Arm B: Anastrozole",
"description": "Participants received 1 mg Anastrozole tablet orally once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days)."
}
],
"classes": [
{
"title": "Pathologic Tumor ypTx",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "OG000"
},
{
"value": "0",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathologic Tumor ypT0",
"categories": [
{
"measurements": [
{
"value": "1",
"groupId": "OG000"
},
{
"value": "0",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathologic Tumor ypTis",
"categories": [
{
"measurements": [
{
"value": "1",
"groupId": "OG000"
},
{
"value": "0",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathologic Tumor ypT1mi",
"categories": [
{
"measurements": [
{
"value": "1",
"groupId": "OG000"
},
{
"value": "0",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathologic Tumor ypT1a",
"categories": [
{
"measurements": [
{
"value": "6",
"groupId": "OG000"
},
{
"value": "1",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathologic Tumor ypT1b",
"categories": [
{
"measurements": [
{
"value": "7",
"groupId": "OG000"
},
{
"value": "2",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathologic Tumor ypT1c",
"categories": [
{
"measurements": [
{
"value": "36",
"groupId": "OG000"
},
{
"value": "14",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathologic Tumor ypT2",
"categories": [
{
"measurements": [
{
"value": "33",
"groupId": "OG000"
},
{
"value": "21",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathologic Tumor ypT3",
"categories": [
{
"measurements": [
{
"value": "4",
"groupId": "OG000"
},
{
"value": "2",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathologic Tumor ypT4a",
"categories": [
{
"measurements": [
{
"value": "1",
"groupId": "OG000"
},
{
"value": "0",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathologic Tumor ypT4b",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "OG000"
},
{
"value": "0",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathologic Tumor ypT4c",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "OG000"
},
{
"value": "0",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathologic Tumor Not Evaluable",
"categories": [
{
"measurements": [
{
"value": "12",
"groupId": "OG000"
},
{
"value": "10",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathological Lymph Nodes ypNX",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "OG000"
},
{
"value": "0",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathological Lymph Nodes ypN0",
"categories": [
{
"measurements": [
{
"value": "51",
"groupId": "OG000"
},
{
"value": "20",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathological Lymph Nodes ypN0(i+)",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "OG000"
},
{
"value": "0",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathological Lymph Nodes ypN1",
"categories": [
{
"measurements": [
{
"value": "5",
"groupId": "OG000"
},
{
"value": "4",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathological Lymph Nodes ypN0(mol+)",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "OG000"
},
{
"value": "0",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathological Lymph Nodes ypN1mi",
"categories": [
{
"measurements": [
{
"value": "4",
"groupId": "OG000"
},
{
"value": "3",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathological Lymph Nodes ypN1a",
"categories": [
{
"measurements": [
{
"value": "21",
"groupId": "OG000"
},
{
"value": "6",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathological Lymph Nodes ypN1b",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "OG000"
},
{
"value": "0",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathological Lymph Nodes ypN1c",
"categories": [
{
"measurements": [
{
"value": "1",
"groupId": "OG000"
},
{
"value": "0",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathological Lymph Nodes ypN2",
"categories": [
{
"measurements": [
{
"value": "2",
"groupId": "OG000"
},
{
"value": "2",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathological Lymph Nodes ypN2a",
"categories": [
{
"measurements": [
{
"value": "3",
"groupId": "OG000"
},
{
"value": "4",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathological Lymph Nodes ypN2b",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "OG000"
},
{
"value": "0",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathological Lymph Nodes ypN3",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "OG000"
},
{
"value": "0",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathological Lymph Nodes ypN3a",
"categories": [
{
"measurements": [
{
"value": "3",
"groupId": "OG000"
},
{
"value": "1",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathological Lymph Nodes ypN3b",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "OG000"
},
{
"value": "0",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathological Lymph Nodes ypN3c",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "OG000"
},
{
"value": "0",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathological Lymph Nodes Not evaluable",
"categories": [
{
"measurements": [
{
"value": "12",
"groupId": "OG000"
},
{
"value": "10",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"timeFrame": "At Cycle 6 Day 18 (approximately 5.5 months), each cycle is 28 days",
"reviewUnit": {
"resetReasons": [
"The description of the scale or categories does not include sufficient information to understand the results reported."
]
},
"description": "<p>Local pathological assessment of the tissue from surgical resection (performed after approximately 5.5 months of treatment), at minimum, included pathologic stage (ypT and ypN stage) as described in the Statistical Analysis Plan (SAP).\nThe number of participants with the following disease staging at post-surgery are summarized:</p><p>Pathologic Tumor - ypT (ypTx, ypT0, ypTis, ypT1mi, ypT1a, ypT1b, ypT1c, ypT2, ypT3, ypT4a, ypT4b, ypT4c) Pathological Lymph Nodes - ypN (ypNX, ypN0, ypN0[i+], ypN0[mol+], ypN1, ypN1mi, ypN1a, ypN1b, ypN1c, ypN2, ypN2a, ypN2b, ypN3, ypN3a, ypN3b, ypN3c).</p>",
"unitOfMeasure": "Participants",
"reportingStatus": "POSTED",
"populationDescription": "Full Analysis Set included all the enrolled participants who were randomized."
},
{
"type": "SECONDARY",
"title": "Pathological Complete Response(pCR) Rate at the Time of Surgical Resection",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "102",
"groupId": "OG000"
},
{
"value": "50",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm A: ARV-471 (Experimental)",
"description": "Participants received 200 mg ARV-471 (2*100 mg tablets) once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days)."
},
{
"id": "OG001",
"title": "Arm B: Anastrozole",
"description": "Participants received 1 mg Anastrozole tablet orally once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days)."
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "1",
"groupId": "OG000"
},
{
"value": "0",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "At Cycle 6 Day 18 (approximately 5.5 months), each cycle is 28 days",
"description": "pCR is defined as no invasive cancer in the breast and sampled axillary lymph nodes following completion of neoadjuvant systemic therapy (ie, Pathologic Tumor - ypT = ypT0 or ypTis, and Pathologic Lymph Nodes - ypN = ypN0 in the current American Joint Committee on Cancer (AJCC) staging system).\npCR rate is the percentage of participants with pCR.",
"unitOfMeasure": "percentage of participants",
"reportingStatus": "POSTED",
"populationDescription": "Full Analysis set included all the enrolled participants who were randomized."
},
{
"type": "SECONDARY",
"title": "Number of Participants With Modified Preoperative Endocrine Prognostic Index (mPEPI) Score of 0 at the Time of Surgical Resection",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "102",
"groupId": "OG000"
},
{
"value": "50",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm A: ARV-471 (Experimental)",
"description": "Participants received 200 mg ARV-471 (2*100 mg tablets) once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days)."
},
{
"id": "OG001",
"title": "Arm B: Anastrozole",
"description": "Participants received 1 mg Anastrozole tablet orally once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days)."
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "21",
"groupId": "OG000"
},
{
"value": "10",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"timeFrame": "At Cycle 6 Day 18 (approximately 5.5 months), each cycle is 28 days",
"description": "mPEPI score was derived from factors assigned a numerical score following Neoadjuvant endocrine treatment (NET).\nTotal mPEPI score assigned to each patient was the sum of the risk points derived from the pathological (pT) stage, lymph node (pN) stage and Ki67 level.\nNumber of participants with score 0 was reported.\nParticipants with mPEPI score of 0 have pathological stage pT1 or pT2, negative lymph nodes pN0 and proliferation index [Ki-67] of less than or equal to 2.7%.",
"unitOfMeasure": "Participants",
"reportingStatus": "POSTED",
"populationDescription": "Full Analysis Set included all the enrolled participants who were randomized."
},
{
"type": "SECONDARY",
"title": "Breast Conserving Surgery (BCS) Rate",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "102",
"groupId": "OG000"
},
{
"value": "50",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm A: ARV-471 (Experimental)",
"description": "Participants received 200 mg ARV-471 (2*100 mg tablets) once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days)."
},
{
"id": "OG001",
"title": "Arm B: Anastrozole",
"description": "Participants received 1 mg Anastrozole tablet orally once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days)."
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "69.6",
"groupId": "OG000",
"lowerLimit": "60.1",
"upperLimit": "77.7"
},
{
"value": "54.0",
"groupId": "OG001",
"lowerLimit": "40.4",
"upperLimit": "67.0"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "At Cycle 6 (from Day 141 to Day 168), each cycle is 28 days",
"description": "Breast conserving surgery (BCS) Rate is the percentage of participants received breast conserving surgery.",
"unitOfMeasure": "Percentage of participants",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "Full Analysis Set included all the enrolled participants who were randomized."
},
{
"type": "SECONDARY",
"title": "Radiographic Response Per Modified Response Evaluation Criteria in Solid Tumors (mRECIST) in Primary Tumor During Cycle 6",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "102",
"groupId": "OG000"
},
{
"value": "50",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm A: ARV-471 (Experimental)",
"description": "Participants received 200 mg ARV-471 (2*100 mg tablets) once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days)."
},
{
"id": "OG001",
"title": "Arm B: Anastrozole",
"description": "Participants received 1 mg Anastrozole tablet orally once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days)."
}
],
"classes": [
{
"title": "CR",
"categories": [
{
"measurements": [
{
"value": "5",
"groupId": "OG000"
},
{
"value": "4",
"groupId": "OG001"
}
]
}
]
},
{
"title": "PR",
"categories": [
{
"measurements": [
{
"value": "37",
"groupId": "OG000"
},
{
"value": "17",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Stable Disease",
"categories": [
{
"measurements": [
{
"value": "38",
"groupId": "OG000"
},
{
"value": "16",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Progressive disease",
"categories": [
{
"measurements": [
{
"value": "3",
"groupId": "OG000"
},
{
"value": "1",
"groupId": "OG001"
}
]
}
]
},
{
"title": "NE",
"categories": [
{
"measurements": [
{
"value": "19",
"groupId": "OG000"
},
{
"value": "12",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"timeFrame": "At Cycle 6 (from Day 141 to Day 168), each cycle is 28 days",
"description": "The number of participants with Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD), Not Evaluable (NE) per mRECIST calculated.\nCR = disappearance of all target lesions, PR is >=30% decrease in sum of diameters of target lesions, progressive disease (PD) is >=20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions.",
"unitOfMeasure": "Participants",
"reportingStatus": "POSTED",
"populationDescription": "Full Analysis Set included all the enrolled participants who were randomized."
},
{
"type": "SECONDARY",
"title": "Percentage Change From Baseline at Cycle 6 Day 1 in Caliper Measurement of the Primary Tumor",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "45",
"groupId": "OG000"
},
{
"value": "19",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm A: ARV-471 (Experimental)",
"description": "Participants received 200 mg ARV-471 (2*100 mg tablets) once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days)."
},
{
"id": "OG001",
"title": "Arm B: Anastrozole",
"description": "Participants received 1 mg Anastrozole tablet orally once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days)."
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "-32.35",
"spread": "23.739",
"groupId": "OG000"
},
{
"value": "-42.88",
"spread": "18.041",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "MEAN",
"timeFrame": "Baseline (Day 1) and Cycle 6 Day 1 (At Day 141), each cycle is 28 days",
"description": "The percentage change from the baseline of the primary breast tumor size in physical exam calculated in caliper measurement.\nCaliper-based response is the maximum percentage decrease or minimum percentage increase if there is no decrease per participant.",
"unitOfMeasure": "Percent change",
"dispersionType": "Standard Deviation",
"reportingStatus": "POSTED",
"populationDescription": "Full Analysis Set included all the enrolled participants who were randomized.\nHere "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure."
}
]
},
"participantFlowModule": {
"groups": [
{
"id": "FG000",
"title": "Arm A: ARV-471 (Experimental)",
"description": "Participants received 200 mg ARV-471 (2*100 mg tablets) once daily for approximately 5.5 months prior to undergoing surgical resection (no later than Cycle 6 Day 18 [C6D18] + 14 days)."
},
{
"id": "FG001",
"title": "Arm B: Anastrozole",
"description": "Participants received 1 mg Anastrozole tablet orally once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days)."
}
],
"periods": [
{
"title": "Overall Study",
"milestones": [
{
"type": "STARTED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "102"
},
{
"groupId": "FG001",
"numSubjects": "50"
}
]
},
{
"type": "Treated",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "101"
},
{
"groupId": "FG001",
"numSubjects": "48"
}
]
},
{
"type": "COMPLETED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "94"
},
{
"groupId": "FG001",
"numSubjects": "41"
}
]
},
{
"type": "NOT COMPLETED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "8"
},
{
"groupId": "FG001",
"numSubjects": "9"
}
]
}
],
"dropWithdraws": [
{
"type": "Lost to Follow-up",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "2"
},
{
"groupId": "FG001",
"numSubjects": "0"
}
]
},
{
"type": "Withdrawal by Subject",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "3"
},
{
"groupId": "FG001",
"numSubjects": "3"
}
]
},
{
"type": "Other: Miscellaneous",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "3"
},
{
"groupId": "FG001",
"numSubjects": "6"
}
]
}
]
}
],
"preAssignmentDetails": "A total of 152 participants were enrolled."
},
"baselineCharacteristicsModule": {
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "102",
"groupId": "BG000"
},
{
"value": "50",
"groupId": "BG001"
},
{
"value": "152",
"groupId": "BG002"
}
]
}
],
"groups": [
{
"id": "BG000",
"title": "Arm A: ARV-471 (Experimental)",
"description": "Participants received 200 mg ARV-471 (2*100 mg tablets) once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days)."
},
{
"id": "BG001",
"title": "Arm B: Anastrozole",
"description": "Participants received 1 mg Anastrozole tablet orally once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days)."
},
{
"id": "BG002",
"title": "Total",
"description": "Total of all reporting groups"
}
],
"measures": [
{
"title": "Age, Continuous",
"classes": [
{
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "102",
"groupId": "BG000"
},
{
"value": "50",
"groupId": "BG001"
},
{
"value": "152",
"groupId": "BG002"
}
]
}
],
"categories": [
{
"measurements": [
{
"value": "67.4",
"spread": "9.23",
"groupId": "BG000"
},
{
"value": "66.8",
"spread": "8.31",
"groupId": "BG001"
},
{
"value": "67.2",
"spread": "8.91",
"groupId": "BG002"
}
]
}
]
}
],
"paramType": "MEAN",
"unitOfMeasure": "years",
"dispersionType": "STANDARD_DEVIATION"
},
{
"title": "Sex: Female, Male",
"classes": [
{
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "102",
"groupId": "BG000"
},
{
"value": "50",
"groupId": "BG001"
},
{
"value": "152",
"groupId": "BG002"
}
]
}
],
"categories": [
{
"title": "Female",
"measurements": [
{
"value": "102",
"groupId": "BG000"
},
{
"value": "50",
"groupId": "BG001"
},
{
"value": "152",
"groupId": "BG002"
}
]
},
{
"title": "Male",
"measurements": [
{
"value": "0",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "0",
"groupId": "BG002"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants"
},
{
"title": "Ethnicity (NIH/OMB)",
"classes": [
{
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "102",
"groupId": "BG000"
},
{
"value": "50",
"groupId": "BG001"
},
{
"value": "152",
"groupId": "BG002"
}
]
}
],
"categories": [
{
"title": "Hispanic or Latino",
"measurements": [
{
"value": "38",
"groupId": "BG000"
},
{
"value": "23",
"groupId": "BG001"
},
{
"value": "61",
"groupId": "BG002"
}
]
},
{
"title": "Not Hispanic or Latino",
"measurements": [
{
"value": "59",
"groupId": "BG000"
},
{
"value": "25",
"groupId": "BG001"
},
{
"value": "84",
"groupId": "BG002"
}
]
},
{
"title": "Unknown or Not Reported",
"measurements": [
{
"value": "5",
"groupId": "BG000"
},
{
"value": "2",
"groupId": "BG001"
},
{
"value": "7",
"groupId": "BG002"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants"
},
{
"title": "Race/Ethnicity, Customized",
"classes": [
{
"title": "American Indian or Alaska Native",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "102",
"groupId": "BG000"
},
{
"value": "50",
"groupId": "BG001"
},
{
"value": "152",
"groupId": "BG002"
}
]
}
],
"categories": [
{
"measurements": [
{
"value": "1",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "1",
"groupId": "BG002"
}
]
}
]
},
{
"title": "Asian",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "102",
"groupId": "BG000"
},
{
"value": "50",
"groupId": "BG001"
},
{
"value": "152",
"groupId": "BG002"
}
]
}
],
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "BG000"
},
{
"value": "1",
"groupId": "BG001"
},
{
"value": "1",
"groupId": "BG002"
}
]
}
]
},
{
"title": "Native Hawaiian or Other Pacific Islander",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "102",
"groupId": "BG000"
},
{
"value": "50",
"groupId": "BG001"
},
{
"value": "152",
"groupId": "BG002"
}
]
}
],
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "0",
"groupId": "BG002"
}
]
}
]
},
{
"title": "Black or African American",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "102",
"groupId": "BG000"
},
{
"value": "50",
"groupId": "BG001"
},
{
"value": "152",
"groupId": "BG002"
}
]
}
],
"categories": [
{
"measurements": [
{
"value": "1",
"groupId": "BG000"
},
{
"value": "2",
"groupId": "BG001"
},
{
"value": "3",
"groupId": "BG002"
}
]
}
]
},
{
"title": "White",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "102",
"groupId": "BG000"
},
{
"value": "50",
"groupId": "BG001"
},
{
"value": "152",
"groupId": "BG002"
}
]
}
],
"categories": [
{
"measurements": [
{
"value": "98",
"groupId": "BG000"
},
{
"value": "46",
"groupId": "BG001"
},
{
"value": "144",
"groupId": "BG002"
}
]
}
]
},
{
"title": "Other",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "102",
"groupId": "BG000"
},
{
"value": "50",
"groupId": "BG001"
},
{
"value": "152",
"groupId": "BG002"
}
]
}
],
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "BG000"
},
{
"value": "1",
"groupId": "BG001"
},
{
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"groupId": "BG002"
}
]
}
]
},
{
"title": "Unknown or Not Reported",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "102",
"groupId": "BG000"
},
{
"value": "50",
"groupId": "BG001"
},
{
"value": "152",
"groupId": "BG002"
}
]
}
],
"categories": [
{
"measurements": [
{
"value": "2",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "2",
"groupId": "BG002"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants"
},
{
"title": "Percentage of Tumor Cells Positive for Ki -67",
"classes": [
{
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "100",
"groupId": "BG000"
},
{
"value": "48",
"groupId": "BG001"
},
{
"value": "148",
"groupId": "BG002"
}
]
}
],
"categories": [
{
"measurements": [
{
"value": "20.6",
"spread": "14.01",
"groupId": "BG000"
},
{
"value": "20.1",
"spread": "12.25",
"groupId": "BG001"
},
{
"value": "20.4",
"spread": "13.42",
"groupId": "BG002"
}
]
}
]
}
],
"paramType": "MEAN",
"description": "Ki-67 expression assessed by immunohistochemical staining in a central laboratory.",
"unitOfMeasure": "Percentage of tumor cells with Ki67",
"dispersionType": "STANDARD_DEVIATION",
"populationDescription": "Only participants with evaluable central Ki-67 results included in the analysis."
}
],
"populationDescription": "Full Analysis Set (FAS) included all the enrolled participants who were randomized."
}
} /annotationSection {
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"unpostedAnnotation": {
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},
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{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
"value": "Baseline (during screening, prior to Day 1) and Day 15"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
"value": "Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Study Drug Discontinuation"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
"value": "An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.\nAn AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention.\nA serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important.\nA TEAE is an AE that emerges or worsens on/after the first dose of ARV-471/Anastrozole to 30 days after the last administration of the study intervention (ie, study drug treatment or surgical resection, whichever occurs last)."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
"value": "From signing of consent to minimum of 30 days after last administration of study drug (up to approximately 6.5 months)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
"value": "Pathologic Stage at the Time of Surgical Resection"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
"value": "<p>Local pathological assessment of the tissue from surgical resection (performed after approximately 5.5 months of treatment), at minimum, included pathologic stage (ypT and ypN stage) as described in the Statistical Analysis Plan (SAP).\nThe number of participants with the following disease staging at post-surgery are summarized:</p><p>Pathologic Tumor - ypT (ypTx, ypT0, ypTis, ypT1mi, ypT1a, ypT1b, ypT1c, ypT2, ypT3, ypT4a, ypT4b, ypT4c) Pathological Lymph Nodes - ypN (ypNX, ypN0, ypN0[i+], ypN0[mol+], ypN1, ypN1mi, ypN1a, ypN1b, ypN1c, ypN2, ypN2a, ypN2b, ypN3, ypN3a, ypN3b, ypN3c).</p>"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
"value": "At Cycle 6 Day 18 (approximately 5.5 months), each cycle is 28 days"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/reviewUnit",
"value": {
"resetReasons": [
"The description of the scale or categories does not include sufficient information to understand the results reported."
]
}
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
"value": "Pathological Complete Response(pCR) Rate at the Time of Surgical Resection"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
"value": "pCR is defined as no invasive cancer in the breast and sampled axillary lymph nodes following completion of neoadjuvant systemic therapy (ie, Pathologic Tumor - ypT = ypT0 or ypTis, and Pathologic Lymph Nodes - ypN = ypN0 in the current American Joint Committee on Cancer (AJCC) staging system).\npCR rate is the percentage of participants with pCR."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
"value": "At Cycle 6 Day 18 (approximately 5.5 months), each cycle is 28 days"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
"value": "Number of Participants With Modified Preoperative Endocrine Prognostic Index (mPEPI) Score of 0 at the Time of Surgical Resection"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/description",
"value": "mPEPI score was derived from factors assigned a numerical score following Neoadjuvant endocrine treatment (NET).\nTotal mPEPI score assigned to each patient was the sum of the risk points derived from the pathological (pT) stage, lymph node (pN) stage and Ki67 level.\nNumber of participants with score 0 was reported.\nParticipants with mPEPI score of 0 have pathological stage pT1 or pT2, negative lymph nodes pN0 and proliferation index [Ki-67] of less than or equal to 2.7%."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
"value": "At Cycle 6 Day 18 (approximately 5.5 months), each cycle is 28 days"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/4/measure",
"value": "Breast Conserving Surgery (BCS) Rate"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/4/description",
"value": "Breast conserving surgery (BCS) Rate is the percentage of participants received breast conserving surgery."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame",
"value": "At Cycle 6 (from Day 141 to Day 168), each cycle is 28 days"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/5/measure",
"value": "Radiographic Response Per Modified Response Evaluation Criteria in Solid Tumors (mRECIST) in Primary Tumor During Cycle 6"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/5/description",
"value": "The number of participants with Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD), Not Evaluable (NE) per mRECIST calculated.\nCR = disappearance of all target lesions, PR is >=30% decrease in sum of diameters of target lesions, progressive disease (PD) is >=20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame",
"value": "At Cycle 6 (from Day 141 to Day 168), each cycle is 28 days"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/6/measure",
"value": "Percentage Change From Baseline at Cycle 6 Day 1 in Caliper Measurement of the Primary Tumor"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/6/description",
"value": "The percentage change from the baseline of the primary breast tumor size in physical exam calculated in caliper measurement.\nCaliper-based response is the maximum percentage decrease or minimum percentage increase if there is no decrease per participant."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/6/timeFrame",
"value": "Baseline (Day 1) and Cycle 6 Day 1 (At Day 141), each cycle is 28 days"
},
{
"op": "replace",
"path": "/protocolSection/eligibilityModule/eligibilityCriteria",
"value": "<p>Inclusion Criteria:</p><ul><li>Post-menopausal females ≥ 18 years.</li><li><p>Histologically or cytologically confirmed ER+ and HER2- breast cancer (per local assessment).\nER and HER2 status must be documented:</p><ul><li>ER+ disease, with ER staining of ≥ 10% of tumor cell nuclei by immunohistochemistry (IHC) per American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines.</li><li>HER2- disease by either IHC or in situ hybridization per ASCO/CAP guidelines.</li><li>Ki-67 score ≥ 5%, analyzed locally.</li></ul></li><li>Clinical T1c-T4c, N0-N2, M0 breast cancer amenable to definitive surgical resection, without bilateral breast ductal carcinoma in situ or invasive breast cancer.</li><li>The primary tumor must be at least 1.5 cm by imaging.</li><li>Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.</li><li>Willingness to undergo a screening biopsy, an on-treatment biopsy and surgical resection.</li></ul><p>Exclusion Criteria:</p><ul><li>Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or cervical carcinoma in situ.</li><li>Any of the following in the previous 6 months: Myocardial infarction; Severe unstable angina; Coronary/peripheral artery bypass graft; Symptomatic congestive heart failure (New York Heart Association class III or IV); Cerebrovascular accident; Transient ischemic attack; Symptomatic pulmonary embolism or other clinically significant episode of thromboembolism.</li><li>Any of the following in the previous 6 months: Congenital long QT syndrome; Torsade de Pointes; Sustained ventricular tachyarrhythmia and ventricular fibrillation; Left anterior hemiblock (bifascicular block); Ongoing cardiac dysrhythmias of NCI CTCAE ≥ Grade 2; Atrial fibrillation of any grade (≥ Grade 2 in the case of asymptomatic lone atrial fibrillation).</li><li>corrected QT (Fridericia method) (QTcF) > 470 msec.</li><li>Active, uncontrolled bacterial, fungal or viral infection, including (but not limited to) hepatitis B virus (HBV), hepatitis C virus (HCV), and known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.</li><li>Active inflammatory gastrointestinal disease, chronic diarrhea, known uncontrolled diverticular disease, or previous gastric resection or lap band surgery.</li><li>Cirrhosis meeting criteria for Child Pugh B and C.</li><li>Prior treatment for breast cancer including systemic therapy (eg, chemotherapy, hormonal therapy), radiation, surgery, or any investigational agents.</li><li>Any live vaccines within 14 days of planned start of first dose of study drug.</li><li>Major surgery (as defined by the Investigator) within four weeks of first dose of study drug.</li></ul>"
},
{
"op": "replace",
"path": "/hasResults",
"value": true
},
{
"op": "add",
"path": "/resultsSection",
"value": {
"moreInfoModule": {
"pointOfContact": {
"email": "clinicaltrialsARV-471@arvinas.com",
"phone": "475-345-3366",
"title": "Arvinas Estrogen Receptor, Inc.",
"organization": "Arvinas Estrogen Receptor, Inc"
},
"certainAgreement": {
"piSponsorEmployee": false,
"restrictiveAgreement": true
}
},
"adverseEventsModule": {
"timeFrame": "From first study drug administration up to approximately 6.5 months.",
"description": "Safety Analysis Set consisting of all enrolled participants who received at least 1 dose of study intervention.\nFor All-Cause Mortality, Full Analysis Set was used which included all the enrolled participants who were randomized.",
"eventGroups": [
{
"id": "EG000",
"title": "Arm A: ARV-471 (Experimental)",
"description": "Participants received 200 mg ARV-471 (2*100 mg tablets) once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days).",
"otherNumAtRisk": 101,
"deathsNumAtRisk": 102,
"otherNumAffected": 72,
"seriousNumAtRisk": 101,
"deathsNumAffected": 0,
"seriousNumAffected": 4
},
{
"id": "EG001",
"title": "Arm B: Anastrozole",
"description": "Participants received 1 mg Anastrozole tablet orally once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days).",
"otherNumAtRisk": 48,
"deathsNumAtRisk": 50,
"otherNumAffected": 32,
"seriousNumAtRisk": 48,
"deathsNumAffected": 0,
"seriousNumAffected": 5
}
],
"otherEvents": [
{
"term": "Anaemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 3,
"numAffected": 3
}
],
"organSystem": "Blood and lymphatic system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "Vertigo",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 7,
"numAffected": 7
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Ear and labyrinth disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "Constipation",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 19,
"numAffected": 16
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 3,
"numAffected": 3
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "Nausea",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 16,
"numAffected": 15
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 2,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "Asthenia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 24,
"numAffected": 21
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 5,
"numAffected": 5
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "Fatigue",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 14,
"numAffected": 13
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 3,
"numAffected": 3
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "COVID-19",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 6,
"numAffected": 6
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "Nasopharyngitis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 4,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 3,
"numAffected": 3
}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "Urinary tract infection",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 10,
"numAffected": 8
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "Alanine aminotransferase increased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 6,
"numAffected": 6
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Investigations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "Decreased appetite",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 10,
"numAffected": 8
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "Arthralgia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 16,
"numAffected": 14
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 15,
"numAffected": 15
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "Dizziness",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 5,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 3,
"numAffected": 3
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "Headache",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 10,
"numAffected": 8
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "Insomnia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 10,
"numAffected": 9
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Psychiatric disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "Alopecia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 3,
"numAffected": 3
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "Hot flush",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 28,
"numAffected": 25
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 10,
"numAffected": 10
}
],
"organSystem": "Vascular disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "Hypertension",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 18,
"numAffected": 12
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 4,
"numAffected": 4
}
],
"organSystem": "Vascular disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
}
],
"seriousEvents": [
{
"term": "Angina pectoris",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "Cardiac arrest",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "Bacteraemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "COVID-19",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "Post procedural infection",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "Postoperative wound infection",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "Pyelonephritis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "Post procedural haematoma",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Injury, poisoning and procedural complications",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "Ataxia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "Encephalopathy",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
},
{
"term": "Mental status change",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 101,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 48,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Psychiatric disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 27.1"
}
],
"frequencyThreshold": "5"
},
"outcomeMeasuresModule": {
"outcomeMeasures": [
{
"type": "PRIMARY",
"title": "Percent Reduction in Ki-67 Expression From Baseline to Day 15 in Tumor Biopsies",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "93",
"groupId": "OG000"
},
{
"value": "46",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm A: ARV-471 (Experimental)",
"description": "Participants received 200 mg ARV-471 (2*100 mg tablets) once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days)."
},
{
"id": "OG001",
"title": "Arm B: Anastrozole",
"description": "Participants received 1 mg Anastrozole tablet orally once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days)."
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "71.4",
"groupId": "OG000",
"lowerLimit": "60.6",
"upperLimit": "79.3"
},
{
"value": "72.9",
"groupId": "OG001",
"lowerLimit": "57.8",
"upperLimit": "82.6"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "Baseline (during screening, prior to Day 1) and Day 15",
"description": "Tumor biopsy Ki-67 expression (% of tumor cells that are positive for Ki-67) at baseline and Cycle 1 Day 15 (C1D15) was collected.\nKi-67 expression was assessed by immunohistochemical staining in a central laboratory.\nThe log-transformed Ki-67 after approximately 2 weeks of treatment as a percentage of the baseline value, ie, the ratio between the Ki-67 measurements obtained from C1D15 visit and baseline was modelled using a generalized linear model (GLM) with both stratification factors (ie, baseline Ki-67 score and the tumor size) and treatment as co-variates.\nThe treatment effects were back transformed into geometric means and their Confidence Intervals.\nThe percent change, in other words, relative reduction, of Ki-67 after 2 weeks of treatment is reported as the complement of the ratio between the Ki-67 measurement from C1D15 and baseline, that is 100% × (1-Ki-67 from C1D15/Ki-67 from baseline).",
"unitOfMeasure": "Percent reduction",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "Ki-67 Evaluable Set included all enrolled participants who were randomized and received at least one dose of study treatment and had evaluable central Ki-67 measurements other than '0' or '< 1' from baseline and evaluable Ki-67 measurements from C1D15 visits.",
"measureCategoriesReviewUnit": {
"resetReasons": [
"The Measure Type appears inaccurate."
]
}
},
{
"type": "SECONDARY",
"title": "Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Study Drug Discontinuation",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "101",
"groupId": "OG000"
},
{
"value": "48",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm A: ARV-471 (Experimental)",
"description": "Participants received 200 mg ARV-471 (2*100 mg tablets) once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days)."
},
{
"id": "OG001",
"title": "Arm B: Anastrozole",
"description": "Participants received 1 mg Anastrozole tablet orally once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days)."
}
],
"classes": [
{
"title": "TEAEs",
"categories": [
{
"measurements": [
{
"value": "82",
"groupId": "OG000"
},
{
"value": "37",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Serious TEAEs",
"categories": [
{
"measurements": [
{
"value": "4",
"groupId": "OG000"
},
{
"value": "5",
"groupId": "OG001"
}
]
}
]
},
{
"title": "TEAEs leading to study drug discontinuation",
"categories": [
{
"measurements": [
{
"value": "3",
"groupId": "OG000"
},
{
"value": "4",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"timeFrame": "From signing of consent to minimum of 30 days after last administration of study drug (up to approximately 6.5 months)",
"description": "An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.\nAn AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention.\nA serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important.\nA TEAE is an AE that emerges or worsens on/after the first dose of ARV-471/Anastrozole to 30 days after the last administration of the study intervention (ie, study drug treatment or surgical resection, whichever occurs last).",
"unitOfMeasure": "Participants",
"reportingStatus": "POSTED",
"populationDescription": "Safety Analysis Set which consisted of all enrolled participants who received at least 1 dose of study intervention."
},
{
"type": "SECONDARY",
"title": "Pathologic Stage at the Time of Surgical Resection",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "102",
"groupId": "OG000"
},
{
"value": "50",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm A: ARV-471 (Experimental)",
"description": "Participants received 200 mg ARV-471 (2*100 mg tablets) once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days)."
},
{
"id": "OG001",
"title": "Arm B: Anastrozole",
"description": "Participants received 1 mg Anastrozole tablet orally once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days)."
}
],
"classes": [
{
"title": "Pathologic Tumor ypTx",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "OG000"
},
{
"value": "0",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathologic Tumor ypT0",
"categories": [
{
"measurements": [
{
"value": "1",
"groupId": "OG000"
},
{
"value": "0",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathologic Tumor ypTis",
"categories": [
{
"measurements": [
{
"value": "1",
"groupId": "OG000"
},
{
"value": "0",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathologic Tumor ypT1mi",
"categories": [
{
"measurements": [
{
"value": "1",
"groupId": "OG000"
},
{
"value": "0",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathologic Tumor ypT1a",
"categories": [
{
"measurements": [
{
"value": "6",
"groupId": "OG000"
},
{
"value": "1",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathologic Tumor ypT1b",
"categories": [
{
"measurements": [
{
"value": "7",
"groupId": "OG000"
},
{
"value": "2",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathologic Tumor ypT1c",
"categories": [
{
"measurements": [
{
"value": "36",
"groupId": "OG000"
},
{
"value": "14",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathologic Tumor ypT2",
"categories": [
{
"measurements": [
{
"value": "33",
"groupId": "OG000"
},
{
"value": "21",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathologic Tumor ypT3",
"categories": [
{
"measurements": [
{
"value": "4",
"groupId": "OG000"
},
{
"value": "2",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathologic Tumor ypT4a",
"categories": [
{
"measurements": [
{
"value": "1",
"groupId": "OG000"
},
{
"value": "0",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathologic Tumor ypT4b",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "OG000"
},
{
"value": "0",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathologic Tumor ypT4c",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "OG000"
},
{
"value": "0",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathologic Tumor Not Evaluable",
"categories": [
{
"measurements": [
{
"value": "12",
"groupId": "OG000"
},
{
"value": "10",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathological Lymph Nodes ypNX",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "OG000"
},
{
"value": "0",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathological Lymph Nodes ypN0",
"categories": [
{
"measurements": [
{
"value": "51",
"groupId": "OG000"
},
{
"value": "20",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathological Lymph Nodes ypN0(i+)",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "OG000"
},
{
"value": "0",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathological Lymph Nodes ypN1",
"categories": [
{
"measurements": [
{
"value": "5",
"groupId": "OG000"
},
{
"value": "4",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathological Lymph Nodes ypN0(mol+)",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "OG000"
},
{
"value": "0",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathological Lymph Nodes ypN1mi",
"categories": [
{
"measurements": [
{
"value": "4",
"groupId": "OG000"
},
{
"value": "3",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathological Lymph Nodes ypN1a",
"categories": [
{
"measurements": [
{
"value": "21",
"groupId": "OG000"
},
{
"value": "6",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathological Lymph Nodes ypN1b",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "OG000"
},
{
"value": "0",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathological Lymph Nodes ypN1c",
"categories": [
{
"measurements": [
{
"value": "1",
"groupId": "OG000"
},
{
"value": "0",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathological Lymph Nodes ypN2",
"categories": [
{
"measurements": [
{
"value": "2",
"groupId": "OG000"
},
{
"value": "2",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathological Lymph Nodes ypN2a",
"categories": [
{
"measurements": [
{
"value": "3",
"groupId": "OG000"
},
{
"value": "4",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathological Lymph Nodes ypN2b",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "OG000"
},
{
"value": "0",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathological Lymph Nodes ypN3",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "OG000"
},
{
"value": "0",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathological Lymph Nodes ypN3a",
"categories": [
{
"measurements": [
{
"value": "3",
"groupId": "OG000"
},
{
"value": "1",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathological Lymph Nodes ypN3b",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "OG000"
},
{
"value": "0",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathological Lymph Nodes ypN3c",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "OG000"
},
{
"value": "0",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Pathological Lymph Nodes Not evaluable",
"categories": [
{
"measurements": [
{
"value": "12",
"groupId": "OG000"
},
{
"value": "10",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"timeFrame": "At Cycle 6 Day 18 (approximately 5.5 months), each cycle is 28 days",
"reviewUnit": {
"resetReasons": [
"The description of the scale or categories does not include sufficient information to understand the results reported."
]
},
"description": "<p>Local pathological assessment of the tissue from surgical resection (performed after approximately 5.5 months of treatment), at minimum, included pathologic stage (ypT and ypN stage) as described in the Statistical Analysis Plan (SAP).\nThe number of participants with the following disease staging at post-surgery are summarized:</p><p>Pathologic Tumor - ypT (ypTx, ypT0, ypTis, ypT1mi, ypT1a, ypT1b, ypT1c, ypT2, ypT3, ypT4a, ypT4b, ypT4c) Pathological Lymph Nodes - ypN (ypNX, ypN0, ypN0[i+], ypN0[mol+], ypN1, ypN1mi, ypN1a, ypN1b, ypN1c, ypN2, ypN2a, ypN2b, ypN3, ypN3a, ypN3b, ypN3c).</p>",
"unitOfMeasure": "Participants",
"reportingStatus": "POSTED",
"populationDescription": "Full Analysis Set included all the enrolled participants who were randomized."
},
{
"type": "SECONDARY",
"title": "Pathological Complete Response(pCR) Rate at the Time of Surgical Resection",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "102",
"groupId": "OG000"
},
{
"value": "50",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm A: ARV-471 (Experimental)",
"description": "Participants received 200 mg ARV-471 (2*100 mg tablets) once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days)."
},
{
"id": "OG001",
"title": "Arm B: Anastrozole",
"description": "Participants received 1 mg Anastrozole tablet orally once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days)."
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "1",
"groupId": "OG000"
},
{
"value": "0",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "At Cycle 6 Day 18 (approximately 5.5 months), each cycle is 28 days",
"description": "pCR is defined as no invasive cancer in the breast and sampled axillary lymph nodes following completion of neoadjuvant systemic therapy (ie, Pathologic Tumor - ypT = ypT0 or ypTis, and Pathologic Lymph Nodes - ypN = ypN0 in the current American Joint Committee on Cancer (AJCC) staging system).\npCR rate is the percentage of participants with pCR.",
"unitOfMeasure": "percentage of participants",
"reportingStatus": "POSTED",
"populationDescription": "Full Analysis set included all the enrolled participants who were randomized."
},
{
"type": "SECONDARY",
"title": "Number of Participants With Modified Preoperative Endocrine Prognostic Index (mPEPI) Score of 0 at the Time of Surgical Resection",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "102",
"groupId": "OG000"
},
{
"value": "50",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm A: ARV-471 (Experimental)",
"description": "Participants received 200 mg ARV-471 (2*100 mg tablets) once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days)."
},
{
"id": "OG001",
"title": "Arm B: Anastrozole",
"description": "Participants received 1 mg Anastrozole tablet orally once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days)."
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "21",
"groupId": "OG000"
},
{
"value": "10",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"timeFrame": "At Cycle 6 Day 18 (approximately 5.5 months), each cycle is 28 days",
"description": "mPEPI score was derived from factors assigned a numerical score following Neoadjuvant endocrine treatment (NET).\nTotal mPEPI score assigned to each patient was the sum of the risk points derived from the pathological (pT) stage, lymph node (pN) stage and Ki67 level.\nNumber of participants with score 0 was reported.\nParticipants with mPEPI score of 0 have pathological stage pT1 or pT2, negative lymph nodes pN0 and proliferation index [Ki-67] of less than or equal to 2.7%.",
"unitOfMeasure": "Participants",
"reportingStatus": "POSTED",
"populationDescription": "Full Analysis Set included all the enrolled participants who were randomized."
},
{
"type": "SECONDARY",
"title": "Breast Conserving Surgery (BCS) Rate",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "102",
"groupId": "OG000"
},
{
"value": "50",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm A: ARV-471 (Experimental)",
"description": "Participants received 200 mg ARV-471 (2*100 mg tablets) once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days)."
},
{
"id": "OG001",
"title": "Arm B: Anastrozole",
"description": "Participants received 1 mg Anastrozole tablet orally once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days)."
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "69.6",
"groupId": "OG000",
"lowerLimit": "60.1",
"upperLimit": "77.7"
},
{
"value": "54.0",
"groupId": "OG001",
"lowerLimit": "40.4",
"upperLimit": "67.0"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "At Cycle 6 (from Day 141 to Day 168), each cycle is 28 days",
"description": "Breast conserving surgery (BCS) Rate is the percentage of participants received breast conserving surgery.",
"unitOfMeasure": "Percentage of participants",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "Full Analysis Set included all the enrolled participants who were randomized."
},
{
"type": "SECONDARY",
"title": "Radiographic Response Per Modified Response Evaluation Criteria in Solid Tumors (mRECIST) in Primary Tumor During Cycle 6",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "102",
"groupId": "OG000"
},
{
"value": "50",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm A: ARV-471 (Experimental)",
"description": "Participants received 200 mg ARV-471 (2*100 mg tablets) once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days)."
},
{
"id": "OG001",
"title": "Arm B: Anastrozole",
"description": "Participants received 1 mg Anastrozole tablet orally once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days)."
}
],
"classes": [
{
"title": "CR",
"categories": [
{
"measurements": [
{
"value": "5",
"groupId": "OG000"
},
{
"value": "4",
"groupId": "OG001"
}
]
}
]
},
{
"title": "PR",
"categories": [
{
"measurements": [
{
"value": "37",
"groupId": "OG000"
},
{
"value": "17",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Stable Disease",
"categories": [
{
"measurements": [
{
"value": "38",
"groupId": "OG000"
},
{
"value": "16",
"groupId": "OG001"
}
]
}
]
},
{
"title": "Progressive disease",
"categories": [
{
"measurements": [
{
"value": "3",
"groupId": "OG000"
},
{
"value": "1",
"groupId": "OG001"
}
]
}
]
},
{
"title": "NE",
"categories": [
{
"measurements": [
{
"value": "19",
"groupId": "OG000"
},
{
"value": "12",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"timeFrame": "At Cycle 6 (from Day 141 to Day 168), each cycle is 28 days",
"description": "The number of participants with Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD), Not Evaluable (NE) per mRECIST calculated.\nCR = disappearance of all target lesions, PR is >=30% decrease in sum of diameters of target lesions, progressive disease (PD) is >=20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions.",
"unitOfMeasure": "Participants",
"reportingStatus": "POSTED",
"populationDescription": "Full Analysis Set included all the enrolled participants who were randomized."
},
{
"type": "SECONDARY",
"title": "Percentage Change From Baseline at Cycle 6 Day 1 in Caliper Measurement of the Primary Tumor",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "45",
"groupId": "OG000"
},
{
"value": "19",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm A: ARV-471 (Experimental)",
"description": "Participants received 200 mg ARV-471 (2*100 mg tablets) once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days)."
},
{
"id": "OG001",
"title": "Arm B: Anastrozole",
"description": "Participants received 1 mg Anastrozole tablet orally once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days)."
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "-32.35",
"spread": "23.739",
"groupId": "OG000"
},
{
"value": "-42.88",
"spread": "18.041",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "MEAN",
"timeFrame": "Baseline (Day 1) and Cycle 6 Day 1 (At Day 141), each cycle is 28 days",
"description": "The percentage change from the baseline of the primary breast tumor size in physical exam calculated in caliper measurement.\nCaliper-based response is the maximum percentage decrease or minimum percentage increase if there is no decrease per participant.",
"unitOfMeasure": "Percent change",
"dispersionType": "Standard Deviation",
"reportingStatus": "POSTED",
"populationDescription": "Full Analysis Set included all the enrolled participants who were randomized.\nHere "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure."
}
]
},
"participantFlowModule": {
"groups": [
{
"id": "FG000",
"title": "Arm A: ARV-471 (Experimental)",
"description": "Participants received 200 mg ARV-471 (2*100 mg tablets) once daily for approximately 5.5 months prior to undergoing surgical resection (no later than Cycle 6 Day 18 [C6D18] + 14 days)."
},
{
"id": "FG001",
"title": "Arm B: Anastrozole",
"description": "Participants received 1 mg Anastrozole tablet orally once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days)."
}
],
"periods": [
{
"title": "Overall Study",
"milestones": [
{
"type": "STARTED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "102"
},
{
"groupId": "FG001",
"numSubjects": "50"
}
]
},
{
"type": "Treated",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "101"
},
{
"groupId": "FG001",
"numSubjects": "48"
}
]
},
{
"type": "COMPLETED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "94"
},
{
"groupId": "FG001",
"numSubjects": "41"
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