NCT01147016
Version 8 to 9 · Barbara Ann Karmanos Cancer Institute
Patch inspector
Manual review pending.
arms_or_interventions_changeeligibility_criteria_change None recorded.
9b7f5154e4c5d116091db6bb273c8fca566239306ece783cbc9396ded718e453/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure. [ "HER2Bi-armed activated T cells + Neoadjuvant Chemotherapy" ]
/protocolSection/armsInterventionsModule/interventions/1/armGroupLabels arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure. [ "HER2Bi-armed activated T cells + Neoadjuvant Chemotherapy" ]
/protocolSection/armsInterventionsModule/interventions/1/otherNames arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure. [ "Cytoxan®¶" ]
/protocolSection/armsInterventionsModule/interventions/2/armGroupLabels arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure. [ "HER2Bi-armed activated T cells + Neoadjuvant Chemotherapy" ]
/protocolSection/armsInterventionsModule/interventions/2/otherNames arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure. [ "Adriamycin®¶", "Rubex®¶" ]
/protocolSection/armsInterventionsModule/interventions/3/armGroupLabels arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure. [ "HER2Bi-armed activated T cells + Neoadjuvant Chemotherapy" ]
/protocolSection/armsInterventionsModule/interventions/3/otherNames arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure. [ "Abraxane®", "Onxol®", "Taxol" ]
/protocolSection/armsInterventionsModule/interventions/4/armGroupLabels arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure. [ "HER2Bi-armed activated T cells + Neoadjuvant Chemotherapy" ]
/protocolSection/armsInterventionsModule/interventions/5/armGroupLabels arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure. [ "HER2Bi-armed activated T cells + Neoadjuvant Chemotherapy" ]
/protocolSection/armsInterventionsModule/interventions/6/armGroupLabels arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure. [ "HER2Bi-armed activated T cells + Neoadjuvant Chemotherapy" ]
/protocolSection/armsInterventionsModule/armGroups arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure. [
{
"type": "EXPERIMENTAL",
"label": "HER2Bi-armed activated T cells + Neoadjuvant Chemotherapy",
"description": "<p>HER2Bi-armed activated T cells - Total of 4 of the T cell infusions IV over a period of 1 month</p><p>Cyclophosphamide, doxorubicin hydrochloride, paclitaxel -As prescribed by physician, standard of care.</p>",
"interventionNames": [
"Biological: HER2Bi-armed activated T cells",
"Drug: cyclophosphamide",
"Drug: doxorubicin hydrochloride",
"Drug: paclitaxel",
"Other: laboratory biomarker analysis",
"Procedure: neoadjuvant therapy",
"Procedure: therapeutic conventional surgery"
]
}
] /protocolSection/eligibilityModule/eligibilityCriteria eligibility_criteria_change Eligibility criteria changes can alter the studied population. <p>DISEASE CHARACTERISTICS:</p><ul><li><p>Diagnosis of adenocarcinoma of the breast by core-needle biopsy</p><ul><li>Palpable primary breast tumor measuring ≥ 2.0 cm on physical exam or imaging</li><li>Stage II or III disease</li><li>HER2-negative disease by IHC or FISH (0-2+)</li><li>cN0 or cN1 disease allowed (no ipsilateral cN2a, cN2b, or cN3 disease)</li><li>Operable disease</li></ul></li><li><p>Patients with either skeletal pain or alkaline phosphatase (ALP) that is > upper limit of normal (ULN) but ≤ 2.5 times ULN are eligible provided bone scans do not demonstrate metastatic disease</p><ul><li>Suspicious findings on bone scan must be confirmed to be benign by x-ray, MRI, or biopsy</li></ul></li><li>No other definitive clinical or radiologic evidence of metastatic disease</li><li>No synchronous bilateral breast cancer (invasive or ductal carcinoma in situ [DCIS])</li><li><p>No prior invasive breast cancer</p><ul><li>DCIS and lobular carcinoma in situ (LCIS) allowed</li></ul></li><li>Estrogen receptor-negative (< 10% by IHC) and progesterone receptor-negative (< 10% by IHC) disease</li></ul><p>PATIENT CHARACTERISTICS:</p><ul><li>Menopausal status not specified</li><li>ECOG performance status 0-1</li><li>ANC ≥ 1,200/mm^3</li><li>Platelet count ≥ 100,000/mm^3</li><li>Hemoglobin ≥ 10 g/dL</li><li>Total bilirubin ≤ ULN (unless the patient has a grade 1 bilirubin elevation [> ULN to 1.5 times ULN] resulting from Gilbert disease or similar syndrome due to slow conjugation of bilirubin)</li><li>ALP ≤ 2.5 times ULN*</li><li>AST ≤ 1.5 times ULN* NOTE: *ALP and AST may not both be > ULN. Patients with AST or ALP > ULN must not have demonstrable metastatic disease on liver imaging.</li><li>Serum creatinine ≤ ULN</li><li>Not pregnant or nursing</li><li>Fertile patients must use effective non-hormonal contraception during and for ≥ 3 months after completion of study treatment</li><li>Sufficient material in pre-treatment core biopsy for correlative studies</li><li>VEF > 50% (by MUGA or ECHO)</li><li>Pulmonary function test-FEV_1, DLCO, and forced vital capcity ≥ 50% of predicted</li><li>No history of invasive breast cancer (history of DCIS or LCIS allowed)</li><li>No other malignancies except for carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin unless the patient is considered to be disease-free for ≥ 5 years before randomization and is deemed by her physician to be at low risk for recurrence</li><li><p>No cardiac disease that would preclude the use of anthracyclines, including any of the following:</p><ul><li>Angina pectoris requiring antianginal medication</li><li>History of documented congestive heart failure</li><li>Serious cardiac arrhythmia requiring medication</li><li>Sever conduction abnormality</li><li>Valvular disease with documented cardiac function compromise</li><li>Uncontrolled hypertension defined as BP > 140/90 mm Hg on antihypertensive therapy (patients with hypertension that is well-controlled on medication are eligible)</li></ul></li><li>No history of myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LV function</li><li>No symptomatic peripheral vascular disease</li><li>No sensory or motor neuropathy ≥ grade 2, as defined by the NCI's CTCAE v3.0</li><li>No other nonmalignant systemic disease (e.g., cardiovascular, renal, hepatic, etc.) that would preclude treatment with any of the treatment regimens or would prevent required follow-up</li><li>No psychiatric or addictive disorders or other conditions that, in the opinion of the investigators, would preclude the patient from complying with study treatment</li></ul><p>PRIOR CONCURRENT THERAPY:</p><ul><li>No prior anthracyclines or taxanes for any malignancy</li><li>No prior treatment for this cancer, including radiotherapy, chemotherapy, biotherapy, and/or hormonal therapy</li><li>More than 30 days since prior investigational agents</li><li>At least 1 week since prior and no concurrent sex hormone therapy (e.g., birth control pills, hormonal replacement therapy)</li><li><p>No concurrent steroids except for adrenal failure, septic shock, pulmonary toxicity, or hormones administered for non-disease-related conditions (e.g., insulin for diabetes)</p><ul><li>Hydrocortisone for severe adverse reactions related to HER2Bi-armed activated T cells allowed</li></ul></li></ul>
<p>Inclusion Criteria</p><ul><li>Signed and dated institutional review board (IRB)-approved consent form</li><li>Women of reproductive potential must agree to use an effective nonhormonal method of contraception during therapy</li><li>Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 and/or Karnofsky PS of >= 70%</li><li>Diagnosis of invasive adenocarcinoma of the breast made by core needle biopsy</li><li>Palpable primary breast tumor measuring >= 2.0 cm on physical exam or imaging</li><li>Patients with stage II-IIIA breast cancer that is HER2-negative by immunohistochemistry (IHC) (0-2+) or fluorescence in situ hybridization (FISH) (HER2/chromosome enumeration probe [CEP]17 amplification ratio < 2.2) for whom definitive surgical treatment after "third generation" neoadjuvant chemoT is planned; Patients with HER2 (3+) cancer by IHC that also demonstrate a FISH ratio <2.2 are also eligible. Estrogen receptor (ER) or progesterone receptor (PR) status can be positive or negative; the receptor status needs to be recorded</li><li>Patients may have lymph node positive or negative disease, as long as they have clinical stage II or IIIA breast cancer; patients may have the lymph nodes assessed by any method deemed appropriate by the treating physicians, including pre-neoadjuvant therapy sentinel lymph node biopsy</li><li>Patients must discontinue sex hormone therapy prior to registration, e.g. birth control pills, hormonal replacement therapy</li><li>Absolute neutrophil count (ANC) must be >= 1200/mm^3</li><li>Platelet count must be >= 100,000/mm^3</li><li>Hemoglobin must be >= 9.0 mg/dL</li><li>Total bilirubin must be =< the upper limit of normal (ULN) for the lab unless the patient has a grade 1 bilirubin elevation (> ULN to 1.5 x ULN) resulting from Gilbert's disease or similar syndrome due to slow conjugation of bilirubin; and</li><li>Alkaline phosphatase must be =< 2.5 x ULN for the lab</li><li>Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) must be =< 1.5 x ULN for the lab</li><li>Alkaline phosphatase and AST/ALT may not both be > the ULN; for example, if the alkaline phosphatase is > the ULN but =< 2.5 x ULN, then the AST/ALT must be =< the ULN; if the AST/ALT is > the ULN but =< 1.5 x ULN, then the alkaline phosphatase must be =< ULN</li><li>Patients with either skeletal pain or alkaline phosphatase that is > ULN must have a bone scan showing they do not have metastatic disease; suspicious findings on bone scan must be confirmed as benign by x-ray, magnetic resonance imaging (MRI), or biopsy</li><li>Patients with AST/ALT or alkaline phosphatase > ULN must have liver imaging that does not demonstrate metastatic disease</li><li>Patients with AST/ALT > ULN must have negative hepatitis studies</li><li>Patients with stage II disease and clinical suspicion for metastatic disease based on reported symptoms, physical examination findings, or laboratory abnormalities must have staging studies demonstrating no evidence of metastatic disease (with exception of axillary lymph nodes or mammary nodes); patients with stage IIIA disease must have staging studies demonstrating no evidence of metastatic disease (with exception of axillary lymph nodes or mammary nodes), even if asymptomatic with normal physical examination and laboratory values; such staging studies must include: chest imaging (chest X-ray, computed tomography [CT], or MRI), abdominal/pelvis imaging (CT or MRI), and bone imaging (bone scan or positron emission tomography [PET]-scan); abnormalities that are indeterminate and too small to biopsy should be followed with further imaging, as appropriate, but do not exclude patients from the study; abnormalities that are suspicious and large enough to biopsy exclude patients from the study, unless a biopsy is performed and is negative for metastatic disease</li><li>Serum creatinine =< 1.5 x ULN for the lab</li><li>Pre-entry core biopsy with sufficient material for correlative studies</li><li>Left Ventricular Ejection Fraction (LVEF) >= 50 % (by multigated acquisition scan [MUGA] or echocardiography)</li></ul><p>Exclusion Criteria</p><ul><li>Tumor determined to be HER2-positive by immunohistochemistry (3+) or by fluorescent in situ hybridization (HER2/CEP17 amplification ratio >= 2.0)</li><li>Tumors clinically staged as T4 or N3</li><li>Definitive evidence of metastatic disease with exception of axillary lymph nodes or mammary nodes</li><li>Synchronous bilateral breast cancer (invasive or ducal carcinoma in situ [DCIS])</li><li>Treatment including radiation therapy, chemoT, biotherapy, and/or hormonal therapy for the currently diagnosed breast cancer prior to study entry</li><li>Any sex hormonal therapy, e.g., birth control pills, ovarian hormonal replacement therapy, etc. (These patients are eligible if this therapy is discontinued 1 week prior to registration)</li><li>Prior history of invasive breast cancer (Patients with a history of DCIS or lobular carcinoma in situ [LCIS] are eligible)</li><li>Prior therapy with anthracyclines for any malignancy</li><li>Other malignancies unless the patient is considered to be disease-free for 5 or more years prior to randomization and is deemed by the physician to be at low risk for recurrence; patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell or squamous cell carcinoma of the skin</li><li><p>Known cardiac disease that would preclude the use of anthracyclines; this includes:</p><ul><li>Angina pectoris that requires the use of anti-anginal medication</li><li>History of documented congestive heart failure</li><li>Serious cardiac arrhythmia requiring medication</li><li>Severe conduction abnormality</li><li>Valvular disease with documented cardiac function compromise; and</li><li>Uncontrolled hypertension defined as blood pressure (BP) that is consistently > 150/90 on antihypertensive therapy at the time of registration (Patients with hypertension that is well controlled on medication are eligible)</li></ul></li><li>History of myocardial infarction (MI) documented by elevated cardiac enzymes with persistent regional wall motion abnormality on assessment of left ventricular (LV) function (Patients with history of MI must have an echo instead of/in addition to a MUGA to evaluate LV wall motion)</li><li>Symptomatic peripheral vascular disease</li><li>Sensory/motor neuropathy >= grade 2, as defined by the National Cancer Institute (NCI)'s Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0)</li><li>Other non-malignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude treatment with any of the treatment regimens or would prevent required follow-up</li><li>Chronic ongoing steroid use at the time of registration for any condition (such as asthma, rheumatoid arthritis, etc)</li><li>Administration of any investigational agents within 30 days before study entry</li><li>Pregnancy or lactation at the time of registration</li><li>Psychiatric or addictive disorders or other conditions that in the opinion of the investigators would preclude the patient from complying with the study protocol.</li></ul><p>Minor changes from these guidelines will be allowed at the discretion of the research team under special circumstances. The reasons for exceptions will be documented</p>
/protocolSection/contactsLocationsModule/overallOfficials/0/name Zeina Nahleh, MD
Lawrence Lum, M.D.
/protocolSection/contactsLocationsModule/locations/0/contacts/1 {
"name": "Zaid Al-Kadhimi, M.D.",
"role": "SUB_INVESTIGATOR"
} /protocolSection/contactsLocationsModule/locations/0/contacts/2 {
"name": "Rouba Ali-Fehmi, M.D.",
"role": "SUB_INVESTIGATOR"
} /protocolSection/contactsLocationsModule/locations/0/contacts/3 {
"name": "Lydia Choi, M.D.",
"role": "PRINCIPAL_INVESTIGATOR"
} /protocolSection/contactsLocationsModule/locations/0/contacts/4 {
"name": "Abhinav Deol, M.D.",
"role": "SUB_INVESTIGATOR"
} /protocolSection/contactsLocationsModule/locations/0/contacts/5 {
"name": "Neb Duric, Ph.D.",
"role": "SUB_INVESTIGATOR"
} /protocolSection/contactsLocationsModule/locations/0/contacts/6 {
"name": "Lawrence Flaherty, M.D.",
"role": "SUB_INVESTIGATOR"
} /protocolSection/contactsLocationsModule/locations/0/contacts/7 {
"name": "David Gorski, M.D., Ph.D.",
"role": "SUB_INVESTIGATOR"
} /protocolSection/contactsLocationsModule/locations/0/contacts/8 {
"name": "Sayeh Lavasani, M.D.",
"role": "SUB_INVESTIGATOR"
} /protocolSection/contactsLocationsModule/locations/0/contacts/9 {
"name": "Michael Simon, M.D., MPH",
"role": "SUB_INVESTIGATOR"
} /protocolSection/contactsLocationsModule/locations/0/contacts/10 {
"name": "Archana Thakur",
"role": "SUB_INVESTIGATOR"
} /protocolSection/statusModule/statusVerifiedDate 2012-01
2012-08
/protocolSection/statusModule/lastUpdateSubmitDate 2012-01-10
2012-08-17
/protocolSection/statusModule/lastUpdatePostDateStruct/date 2012-01-11
2012-08-21
/protocolSection/oversightModule {
"oversightHasDmc": true
} [
{
"op": "replace",
"path": "/protocolSection/statusModule/statusVerifiedDate",
"value": "2012-08"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2012-08-17"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2012-08-21"
},
{
"op": "add",
"path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels",
"value": [
"HER2Bi-armed activated T cells + Neoadjuvant Chemotherapy"
]
},
{
"op": "add",
"path": "/protocolSection/armsInterventionsModule/interventions/1/armGroupLabels",
"value": [
"HER2Bi-armed activated T cells + Neoadjuvant Chemotherapy"
]
},
{
"op": "add",
"path": "/protocolSection/armsInterventionsModule/interventions/1/otherNames",
"value": [
"Cytoxan®¶"
]
},
{
"op": "add",
"path": "/protocolSection/armsInterventionsModule/interventions/2/armGroupLabels",
"value": [
"HER2Bi-armed activated T cells + Neoadjuvant Chemotherapy"
]
},
{
"op": "add",
"path": "/protocolSection/armsInterventionsModule/interventions/2/otherNames",
"value": [
"Adriamycin®¶",
"Rubex®¶"
]
},
{
"op": "add",
"path": "/protocolSection/armsInterventionsModule/interventions/3/armGroupLabels",
"value": [
"HER2Bi-armed activated T cells + Neoadjuvant Chemotherapy"
]
},
{
"op": "add",
"path": "/protocolSection/armsInterventionsModule/interventions/3/otherNames",
"value": [
"Abraxane®",
"Onxol®",
"Taxol"
]
},
{
"op": "add",
"path": "/protocolSection/armsInterventionsModule/interventions/4/armGroupLabels",
"value": [
"HER2Bi-armed activated T cells + Neoadjuvant Chemotherapy"
]
},
{
"op": "add",
"path": "/protocolSection/armsInterventionsModule/interventions/5/armGroupLabels",
"value": [
"HER2Bi-armed activated T cells + Neoadjuvant Chemotherapy"
]
},
{
"op": "add",
"path": "/protocolSection/armsInterventionsModule/interventions/6/armGroupLabels",
"value": [
"HER2Bi-armed activated T cells + Neoadjuvant Chemotherapy"
]
},
{
"op": "add",
"path": "/protocolSection/armsInterventionsModule/armGroups",
"value": [
{
"type": "EXPERIMENTAL",
"label": "HER2Bi-armed activated T cells + Neoadjuvant Chemotherapy",
"description": "<p>HER2Bi-armed activated T cells - Total of 4 of the T cell infusions IV over a period of 1 month</p><p>Cyclophosphamide, doxorubicin hydrochloride, paclitaxel -As prescribed by physician, standard of care.</p>",
"interventionNames": [
"Biological: HER2Bi-armed activated T cells",
"Drug: cyclophosphamide",
"Drug: doxorubicin hydrochloride",
"Drug: paclitaxel",
"Other: laboratory biomarker analysis",
"Procedure: neoadjuvant therapy",
"Procedure: therapeutic conventional surgery"
]
}
]
},
{
"op": "replace",
"path": "/protocolSection/eligibilityModule/eligibilityCriteria",
"value": "<p>Inclusion Criteria</p><ul><li>Signed and dated institutional review board (IRB)-approved consent form</li><li>Women of reproductive potential must agree to use an effective nonhormonal method of contraception during therapy</li><li>Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 and/or Karnofsky PS of >= 70%</li><li>Diagnosis of invasive adenocarcinoma of the breast made by core needle biopsy</li><li>Palpable primary breast tumor measuring >= 2.0 cm on physical exam or imaging</li><li>Patients with stage II-IIIA breast cancer that is HER2-negative by immunohistochemistry (IHC) (0-2+) or fluorescence in situ hybridization (FISH) (HER2/chromosome enumeration probe [CEP]17 amplification ratio < 2.2) for whom definitive surgical treatment after "third generation" neoadjuvant chemoT is planned; Patients with HER2 (3+) cancer by IHC that also demonstrate a FISH ratio <2.2 are also eligible.\nEstrogen receptor (ER) or progesterone receptor (PR) status can be positive or negative; the receptor status needs to be recorded</li><li>Patients may have lymph node positive or negative disease, as long as they have clinical stage II or IIIA breast cancer; patients may have the lymph nodes assessed by any method deemed appropriate by the treating physicians, including pre-neoadjuvant therapy sentinel lymph node biopsy</li><li>Patients must discontinue sex hormone therapy prior to registration, e.g.\nbirth control pills, hormonal replacement therapy</li><li>Absolute neutrophil count (ANC) must be >= 1200/mm^3</li><li>Platelet count must be >= 100,000/mm^3</li><li>Hemoglobin must be >= 9.0 mg/dL</li><li>Total bilirubin must be =< the upper limit of normal (ULN) for the lab unless the patient has a grade 1 bilirubin elevation (> ULN to 1.5 x ULN) resulting from Gilbert's disease or similar syndrome due to slow conjugation of bilirubin; and</li><li>Alkaline phosphatase must be =< 2.5 x ULN for the lab</li><li>Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) must be =< 1.5 x ULN for the lab</li><li>Alkaline phosphatase and AST/ALT may not both be > the ULN; for example, if the alkaline phosphatase is > the ULN but =< 2.5 x ULN, then the AST/ALT must be =< the ULN; if the AST/ALT is > the ULN but =< 1.5 x ULN, then the alkaline phosphatase must be =< ULN</li><li>Patients with either skeletal pain or alkaline phosphatase that is > ULN must have a bone scan showing they do not have metastatic disease; suspicious findings on bone scan must be confirmed as benign by x-ray, magnetic resonance imaging (MRI), or biopsy</li><li>Patients with AST/ALT or alkaline phosphatase > ULN must have liver imaging that does not demonstrate metastatic disease</li><li>Patients with AST/ALT > ULN must have negative hepatitis studies</li><li>Patients with stage II disease and clinical suspicion for metastatic disease based on reported symptoms, physical examination findings, or laboratory abnormalities must have staging studies demonstrating no evidence of metastatic disease (with exception of axillary lymph nodes or mammary nodes); patients with stage IIIA disease must have staging studies demonstrating no evidence of metastatic disease (with exception of axillary lymph nodes or mammary nodes), even if asymptomatic with normal physical examination and laboratory values; such staging studies must include: chest imaging (chest X-ray, computed tomography [CT], or MRI), abdominal/pelvis imaging (CT or MRI), and bone imaging (bone scan or positron emission tomography [PET]-scan); abnormalities that are indeterminate and too small to biopsy should be followed with further imaging, as appropriate, but do not exclude patients from the study; abnormalities that are suspicious and large enough to biopsy exclude patients from the study, unless a biopsy is performed and is negative for metastatic disease</li><li>Serum creatinine =< 1.5 x ULN for the lab</li><li>Pre-entry core biopsy with sufficient material for correlative studies</li><li>Left Ventricular Ejection Fraction (LVEF) >= 50 % (by multigated acquisition scan [MUGA] or echocardiography)</li></ul><p>Exclusion Criteria</p><ul><li>Tumor determined to be HER2-positive by immunohistochemistry (3+) or by fluorescent in situ hybridization (HER2/CEP17 amplification ratio >= 2.0)</li><li>Tumors clinically staged as T4 or N3</li><li>Definitive evidence of metastatic disease with exception of axillary lymph nodes or mammary nodes</li><li>Synchronous bilateral breast cancer (invasive or ducal carcinoma in situ [DCIS])</li><li>Treatment including radiation therapy, chemoT, biotherapy, and/or hormonal therapy for the currently diagnosed breast cancer prior to study entry</li><li>Any sex hormonal therapy, e.g., birth control pills, ovarian hormonal replacement therapy, etc. (These patients are eligible if this therapy is discontinued 1 week prior to registration)</li><li>Prior history of invasive breast cancer (Patients with a history of DCIS or lobular carcinoma in situ [LCIS] are eligible)</li><li>Prior therapy with anthracyclines for any malignancy</li><li>Other malignancies unless the patient is considered to be disease-free for 5 or more years prior to randomization and is deemed by the physician to be at low risk for recurrence; patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell or squamous cell carcinoma of the skin</li><li><p>Known cardiac disease that would preclude the use of anthracyclines; this includes:</p><ul><li>Angina pectoris that requires the use of anti-anginal medication</li><li>History of documented congestive heart failure</li><li>Serious cardiac arrhythmia requiring medication</li><li>Severe conduction abnormality</li><li>Valvular disease with documented cardiac function compromise; and</li><li>Uncontrolled hypertension defined as blood pressure (BP) that is consistently > 150/90 on antihypertensive therapy at the time of registration (Patients with hypertension that is well controlled on medication are eligible)</li></ul></li><li>History of myocardial infarction (MI) documented by elevated cardiac enzymes with persistent regional wall motion abnormality on assessment of left ventricular (LV) function (Patients with history of MI must have an echo instead of/in addition to a MUGA to evaluate LV wall motion)</li><li>Symptomatic peripheral vascular disease</li><li>Sensory/motor neuropathy >= grade 2, as defined by the National Cancer Institute (NCI)'s Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0)</li><li>Other non-malignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude treatment with any of the treatment regimens or would prevent required follow-up</li><li>Chronic ongoing steroid use at the time of registration for any condition (such as asthma, rheumatoid arthritis, etc)</li><li>Administration of any investigational agents within 30 days before study entry</li><li>Pregnancy or lactation at the time of registration</li><li>Psychiatric or addictive disorders or other conditions that in the opinion of the investigators would preclude the patient from complying with the study protocol.</li></ul><p>Minor changes from these guidelines will be allowed at the discretion of the research team under special circumstances.\nThe reasons for exceptions will be documented</p>"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/overallOfficials/0/name",
"value": "Lawrence Lum, M.D."
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/0/contacts/1",
"value": {
"name": "Zaid Al-Kadhimi, M.D.",
"role": "SUB_INVESTIGATOR"
}
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/0/contacts/2",
"value": {
"name": "Rouba Ali-Fehmi, M.D.",
"role": "SUB_INVESTIGATOR"
}
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/0/contacts/3",
"value": {
"name": "Lydia Choi, M.D.",
"role": "PRINCIPAL_INVESTIGATOR"
}
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/0/contacts/4",
"value": {
"name": "Abhinav Deol, M.D.",
"role": "SUB_INVESTIGATOR"
}
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/0/contacts/5",
"value": {
"name": "Neb Duric, Ph.D.",
"role": "SUB_INVESTIGATOR"
}
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/0/contacts/6",
"value": {
"name": "Lawrence Flaherty, M.D.",
"role": "SUB_INVESTIGATOR"
}
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/0/contacts/7",
"value": {
"name": "David Gorski, M.D., Ph.D.",
"role": "SUB_INVESTIGATOR"
}
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/0/contacts/8",
"value": {
"name": "Sayeh Lavasani, M.D.",
"role": "SUB_INVESTIGATOR"
}
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/0/contacts/9",
"value": {
"name": "Michael Simon, M.D., MPH",
"role": "SUB_INVESTIGATOR"
}
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/0/contacts/10",
"value": {
"name": "Archana Thakur",
"role": "SUB_INVESTIGATOR"
}
},
{
"op": "add",
"path": "/protocolSection/oversightModule",
"value": {
"oversightHasDmc": true
}
}
]