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NCT03734029

Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]

Version 9 to 10 · Daiichi Sankyo

Patch inspector

Version 9 to 10

60 operations 8 path groups ctgov_internal_history
ClinicalTrials.gov
Severity is deterministic uncalibrated triage metadata, not validated review priority. Operation-level severity is inferred from deterministic path rules. Rule matches shown per operation are approximate previews (they skip the pipeline's suppression passes); the authoritative classification is the stored event record.
Plain-language summary

Manual review pending.

Rules fired
arms_or_interventions_changeeligibility_criteria_changeprimary_outcome_any_changesecondary_outcome_any_change
Value signals
[
  {
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "signal": "timeline_significant_shift",
    "category": "timeline_significant_shift",
    "new_type": "ESTIMATED",
    "old_type": "ESTIMATED",
    "severity": "medium",
    "direction": "later",
    "new_value": "2023-01-01",
    "old_value": "2022-01-01",
    "delta_days": 365,
    "date_struct": "primaryCompletionDateStruct",
    "new_precision": "day",
    "old_precision": "day"
  },
  {
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "signal": "timeline_significant_shift",
    "category": "timeline_significant_shift",
    "new_type": "ESTIMATED",
    "old_type": "ESTIMATED",
    "severity": "medium",
    "direction": "later",
    "new_value": "2023-01-01",
    "old_value": "2022-01-01",
    "delta_days": 365,
    "date_struct": "completionDateStruct",
    "new_precision": "day",
    "old_precision": "day"
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 19:12:44+00
Raw hash
52a1a3c656c67fc3b30abf4a783a6c8d407cd3d0a176c9be76230172920a88ce
Payload
Source URL
Primary outcomes Outcome measures that define the trial's primary evidence target. Triage: Critical 1 ops
replace /protocolSection/outcomesModule/primaryOutcomes/0/description
Triage: Critical
Primary Outcome Change Operation 22
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
PFS based on BICR is defined as the time from randomization to the first objective (radiographic) documentation of disease progression or death.
After
Time from the date of randomization to the earliest date of the first objective documentation of radiographic disease progression via blinded independent central review (BICR) according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1 or death due to any cause.
Design Trial model, phase, allocation, masking, arms, or interventions. Triage: High 11 ops
replace /protocolSection/armsInterventionsModule/armGroups/0/label
Triage: High
Arm Intervention Change Operation 11
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
DS-8201a
After
Trastuzumab deruxtecan
replace /protocolSection/armsInterventionsModule/armGroups/0/description
Triage: High
Arm Intervention Change Operation 12
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
DS-8201a is administered as an intravenous (IV) infusion every 21 days (Q3W), initially for at least 90 minutes, then, if there is no infusion-related reaction, for a minimum of 30 minutes thereafter.
After
HER2-low, unresectable, and/or metastatic breast cancer participants previously treated with chemotherapy randomized to DS8201a
replace /protocolSection/armsInterventionsModule/armGroups/1/description
Triage: High
Arm Intervention Change Operation 13
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
<p>Physician&#x27;s choice comparative therapy will be administered in accordance with the locally approved label.
The physician&#x27;s choice is predefined, prior to randomization, from the following options:</p><ul><li>Capecitabine</li><li>Eribulin</li><li>Gemcitabine</li><li>Paclitaxel</li><li>Nab-paclitaxel</li></ul>
After
<p>HER2-low, unresectable, and&#x2F;or metastatic breast cancer participants previously treated with chemotherapy randomized to Physician&#x27;s choice from the following options:</p><ul><li>Capecitabine</li><li>Eribulin</li><li>Gemcitabine</li><li>Paclitaxel</li><li>Nab-paclitaxel</li></ul>
replace /protocolSection/armsInterventionsModule/interventions/0/description
Triage: High
Arm Intervention Change Operation 14
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
A lyophilized powder prepared by dilution for IV infusion at a dose of 5.4 mg&#x2F;kg
After
DS-8201a is a lyophilized powder reconstituted into a sterile aqueous solution (100 mg&#x2F;5 mL) to be administered intravenously
replace /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0
Triage: High
Arm Intervention Change Operation 15
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
DS-8201a
After
Trastuzumab deruxtecan
replace /protocolSection/armsInterventionsModule/interventions/0/otherNames/0
Triage: High
Arm Intervention Change Operation 16
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Experimental product
After
DS-8201a
remove /protocolSection/armsInterventionsModule/interventions/1/otherNames
Triage: High
Arm Intervention Change Operation 17
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
[
  "Anti-cancer drug"
]
remove /protocolSection/armsInterventionsModule/interventions/2/otherNames
Triage: High
Arm Intervention Change Operation 18
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
[
  "Anti-cancer Drug"
]
remove /protocolSection/armsInterventionsModule/interventions/3/otherNames
Triage: High
Arm Intervention Change Operation 19
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
[
  "Anti-cancer Drug"
]
remove /protocolSection/armsInterventionsModule/interventions/4/otherNames
Triage: High
Arm Intervention Change Operation 20
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
[
  "Anti-cancer Drug"
]
remove /protocolSection/armsInterventionsModule/interventions/5/otherNames
Triage: High
Arm Intervention Change Operation 21
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
[
  "Anti-cancer Drug"
]
Eligibility Criteria and population definition changes. Triage: High 1 ops
replace /protocolSection/eligibilityModule/eligibilityCriteria
Triage: High
Eligibility Change Operation 27
Matched rules
  • eligibility_criteria_change Eligibility criteria changes can alter the studied population.
Before
<p>Inclusion Criteria:</p><ul><li>Is the age of majority in their country</li><li><p>Has pathologically documented breast cancer that:</p><ol><li>Is unresectable or metastatic</li><li>Has low-HER2 expression defined as IHC 2+&#x2F;ISH- or IHC 1+ (ISH- or untested)</li><li>Is HR-positive or HR-negative</li><li>Has progressed on, and would no longer benefit from, endocrine therapy</li><li>Has been treated with 1 to 2 prior lines of chemotherapy&#x2F;adjuvant in the metastatic setting</li></ol></li><li>Has documented radiologic progression (during or after most recent treatment)</li><li><p>Has adequate tumor samples available or is wiling to provide fresh biopsies prior to randomization for:</p><ol><li>assessment of HER2 status</li><li>assessment of post-treatment status</li></ol></li><li>Has Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1</li><li>Has at least 1 protocol-defined measurable lesion</li><li>Has protocol-defined adequate cardiac, bone marrow, renal, hepatic and blood clotting functions</li><li>If of reproductive&#x2F;childbearing potential, agrees to follow instructions for method(s) of contraception and agrees to avoid preserving ova or sperm for at least 4.5 months after treatment (or longer, per locally approved labels)</li></ul><p>Exclusion Criteria:</p><ul><li>Is ineligible for all options in the physician&#x27;s choice arm</li><li>Has breast cancer ever assessed with high-HER2 expression</li><li>Has previously been treated with any anti-HER2 therapy, including an antibody drug conjugate</li><li>Has uncontrolled or significant cardiovascular disease</li><li>Has spinal cord compression or clinically active central nervous system metastases</li><li>Has history, current, or suspicion of interstitial lung disease&#x2F;pneumonitis</li><li>Has any medical history or condition that per protocol or in the opinion of the investigator is inappropriate for the study</li></ul>
After
<p>Inclusion Criteria:</p><ul><li>Is the age of majority in their country</li><li><p>Has pathologically documented breast cancer that:</p><ol><li>Is unresectable or metastatic</li><li>Has low-HER2 expression defined as IHC 2+&#x2F;ISH- or IHC 1+ (ISH- or untested)</li><li>Is HR-positive or HR-negative</li><li>Has progressed on, and would no longer benefit from, endocrine therapy</li><li>Has been treated with 1 to 2 prior lines of chemotherapy&#x2F;adjuvant in the metastatic setting</li><li>Was never previously HER2-positive (ICH 3+ or ISH+) on prior pathology testing (per American Society of Clinical Oncology-College of American Pathologists [ASCO-CAP] guidelines)</li></ol></li><li>Has documented radiologic progression (during or after most recent treatment)</li><li><p>Has adequate archival tumor samples available or is wiling to provide fresh biopsies prior to randomization for:</p><ol><li>assessment of HER2 status</li><li>assessment of post-treatment status</li></ol></li><li>Has at least 1 protocol-defined measurable lesion</li><li>Has protocol-defined adequate cardiac, bone marrow, renal, hepatic and blood clotting functions</li><li>Male and female participants of reproductive&#x2F;childbearing potential, agrees to follow instructions for method(s) of contraception and agrees to avoid preserving ova or sperm for at least 4.5 months after treatment (or longer, per locally approved labels)</li></ul><p>Exclusion Criteria:</p><ul><li>Is ineligible for all options in the physician&#x27;s choice arm</li><li>Has breast cancer ever assessed with high-HER2 expression</li><li>Has previously been treated with any anti-HER2 therapy, including an antibody drug conjugate</li><li>Has uncontrolled or significant cardiovascular disease</li><li>Has spinal cord compression or clinically active central nervous system metastases</li><li>Has history of (noninfectious) interstitial lung disease (ILD)&#x2F;pneumonitis that required steroids, has current ILD&#x2F;pneumonitis, or suspected ILD&#x2F;pneumonitis that cannot be ruled out by imaging at screening</li><li>Has any medical history or condition that per protocol or in the opinion of the investigator is inappropriate for the study</li></ul>
Secondary outcomes Additional endpoints and outcome descriptions. Triage: High 4 ops
replace /protocolSection/outcomesModule/secondaryOutcomes/0/description
Triage: High
Secondary Outcome Change Operation 23
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
PFS based on Investigator Assessment is defined as the time from randomization to the first clinical observation of disease progression or death.
After
Time from the date of randomization to the first objective documentation of radiographic disease progression via investigator assessment according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1 or death due to any cause.
replace /protocolSection/outcomesModule/secondaryOutcomes/1/description
Triage: High
Secondary Outcome Change Operation 24
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
OS is defined as the time from randomization to death
After
Time from the date of randomization to the date of death for any cause.
If there is no death reported for a participant before the data cutoff for OS analysis, OS will be censored at the last contact date at which the participant is known to be alive.
replace /protocolSection/outcomesModule/secondaryOutcomes/2/description
Triage: High
Secondary Outcome Change Operation 25
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
ORR is defined as the percentage of participants who achieved objective CR or PR, confirmed by a second assessment
After
Percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR), confirmed by a second assessment.
replace /protocolSection/outcomesModule/secondaryOutcomes/3/measure
Triage: High
Secondary Outcome Change Operation 26
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Duration of Response (DoR), based on BICR and Investigator assessment
After
Duration of Response (DoR), Based on Blinded Independent Central Review (BICR) and Investigator Assessment
Timeline Start, primary completion, and completion date movement. Triage: Medium 2 ops
replace /protocolSection/statusModule/primaryCompletionDateStruct/date
Triage: Medium
Timeline Shift Operation 4
Matched rules
  • primary_completion_timeline_change Primary completion date changes are operational timeline signals.
Before
2022-01-01
After
2023-01-01
replace /protocolSection/statusModule/completionDateStruct/date
Triage: Medium
Timeline Shift Operation 5
Matched rules
  • completion_timeline_change Completion date changes are operational timeline signals.
Before
2022-01-01
After
2023-01-01
Contacts and locations Site, contact, and location updates that are usually operational. Triage: Uncategorized 33 ops
add /protocolSection/contactsLocationsModule/locations/1
Triage: Uncategorized
Uncategorized Operation 28
After
{
  "zip": "90095-1690",
  "city": "Los Angeles",
  "state": "California",
  "status": "RECRUITING",
  "country": "United States",
  "contacts": [
    {
      "name": "Principal Investigator",
      "role": "CONTACT",
      "email": "nmcandrew@mednet.ucla.edu",
      "phone": "210-205-0771"
    }
  ],
  "facility": "UCLA School of Medicine",
  "geoPoint": {
    "lat": 34.05223,
    "lon": -118.24368
  }
}
add /protocolSection/contactsLocationsModule/locations/5
Triage: Uncategorized
Uncategorized Operation 29
After
{
  "zip": "07039",
  "city": "Livingston",
  "state": "New Jersey",
  "status": "RECRUITING",
  "country": "United States",
  "contacts": [
    {
      "name": "Principal Investigator",
      "role": "CONTACT",
      "email": "anya.litvak@rwjbh.org",
      "phone": "973-322-5200"
    }
  ],
  "facility": "Saint Barnabas Medical Center",
  "geoPoint": {
    "lat": 40.79593,
    "lon": -74.31487
  }
}
add /protocolSection/contactsLocationsModule/locations/6
Triage: Uncategorized
Uncategorized Operation 30
After
{
  "zip": "10065-6007",
  "city": "New York",
  "state": "New York",
  "status": "RECRUITING",
  "country": "United States",
  "contacts": [
    {
      "name": "Principal Investigator",
      "role": "CONTACT",
      "email": "modis@mskcc.org",
      "phone": "646-888-4564"
    }
  ],
  "facility": "Memorial Sloan Kettering Hospital",
  "geoPoint": {
    "lat": 40.71427,
    "lon": -74.00597
  }
}
add /protocolSection/contactsLocationsModule/locations/7
Triage: Uncategorized
Uncategorized Operation 31
After
{
  "zip": "97239",
  "city": "Portland",
  "state": "Oregon",
  "status": "RECRUITING",
  "country": "United States",
  "contacts": [
    {
      "name": "Principal Investigator",
      "role": "CONTACT",
      "email": "mitri@ohsu.edu",
      "phone": "503-494-9160"
    }
  ],
  "facility": "Oregon Health &amp; Science University",
  "geoPoint": {
    "lat": 45.52345,
    "lon": -122.67621
  }
}
add /protocolSection/contactsLocationsModule/locations/8
Triage: Uncategorized
Uncategorized Operation 32
After
{
  "zip": "15219",
  "city": "Pittsburgh",
  "state": "Pennsylvania",
  "status": "RECRUITING",
  "country": "United States",
  "contacts": [
    {
      "name": "Principal Investigator",
      "role": "CONTACT",
      "email": "brufskyam@upmc.edu",
      "phone": "412-641-6500"
    }
  ],
  "facility": "University of Pittsburgh Medical Center Health System",
  "geoPoint": {
    "lat": 40.44062,
    "lon": -79.99589
  }
}
add /protocolSection/contactsLocationsModule/locations/10
Triage: Uncategorized
Uncategorized Operation 33
After
{
  "zip": "37909",
  "city": "Knoxville",
  "state": "Tennessee",
  "status": "RECRUITING",
  "country": "United States",
  "contacts": [
    {
      "name": "Principal Investigator",
      "role": "CONTACT",
      "email": "rbrig@hcahealthcare.com",
      "phone": "865-549-4107"
    }
  ],
  "facility": "Brig Center for Cancer Care and Survivorship",
  "geoPoint": {
    "lat": 35.96064,
    "lon": -83.92074
  }
}
add /protocolSection/contactsLocationsModule/locations/13
Triage: Uncategorized
Uncategorized Operation 34
After
{
  "zip": "5020",
  "city": "Salzburg",
  "status": "RECRUITING",
  "country": "Austria",
  "contacts": [
    {
      "name": "Principal Investigator",
      "role": "CONTACT",
      "email": "r.greil@salk.at",
      "phone": "+43 5725557700"
    }
  ],
  "facility": "LKH - Universitätsklinikum der PMU Salzburg",
  "geoPoint": {
    "lat": 47.79941,
    "lon": 13.04399
  }
}
add /protocolSection/contactsLocationsModule/locations/14
Triage: Uncategorized
Uncategorized Operation 35
After
{
  "zip": "14076",
  "city": "Caen",
  "state": "Calvados",
  "status": "RECRUITING",
  "country": "France",
  "contacts": [
    {
      "name": "Principal Investigator",
      "role": "CONTACT",
      "email": "c.levy@baclesse.unicancer.fr",
      "phone": "+33 31455050"
    }
  ],
  "facility": "Centre François Baclesse",
  "geoPoint": {
    "lat": 49.18585,
    "lon": -0.35912
  }
}
add /protocolSection/contactsLocationsModule/locations/15
Triage: Uncategorized
Uncategorized Operation 36
After
{
  "zip": "22190",
  "city": "Plérin",
  "state": "Cotes d'Armor",
  "status": "RECRUITING",
  "country": "France",
  "contacts": [
    {
      "name": "Principal Investigator",
      "role": "CONTACT",
      "email": "ac.hardy@cario-sante.fr",
      "phone": "+33 296752216"
    }
  ],
  "facility": "CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie",
  "geoPoint": {
    "lat": 48.53451,
    "lon": -2.76975
  }
}
add /protocolSection/contactsLocationsModule/locations/16
Triage: Uncategorized
Uncategorized Operation 37
After
{
  "zip": "43012",
  "city": "Le Puy-en-Velay",
  "state": "Loiret",
  "status": "RECRUITING",
  "country": "France",
  "contacts": [
    {
      "name": "Principal Investigator",
      "role": "CONTACT",
      "email": "kheireddine.benmammar@ch-lepuy.fr"
    }
  ],
  "facility": "Centre Hospitalier Emile Roux",
  "geoPoint": {
    "lat": 45.04366,
    "lon": 3.88523
  }
}
add /protocolSection/contactsLocationsModule/locations/18
Triage: Uncategorized
Uncategorized Operation 38
After
{
  "zip": "84918",
  "city": "Avignon",
  "state": "Vaculuse",
  "status": "RECRUITING",
  "country": "France",
  "contacts": [
    {
      "name": "Principal Investigator",
      "role": "CONTACT",
      "email": "j.grenier@isc84.org",
      "phone": "+33149812459"
    }
  ],
  "facility": "Institut Sainte Catherine",
  "geoPoint": {
    "lat": 43.94834,
    "lon": 4.80892
  }
}
add /protocolSection/contactsLocationsModule/locations/19
Triage: Uncategorized
Uncategorized Operation 39
After
{
  "zip": "94160",
  "city": "Saint-Mandé",
  "state": "Val De Marne",
  "status": "RECRUITING",
  "country": "France",
  "contacts": [
    {
      "name": "Principal Investigator",
      "role": "CONTACT",
      "email": "carole.helissey@gmail.com",
      "phone": "+33143985981"
    }
  ],
  "facility": "Hôpital d&#x27;Instruction des Armees Begin*",
  "geoPoint": {
    "lat": 48.83864,
    "lon": 2.41579
  }
}
add /protocolSection/contactsLocationsModule/locations/20
Triage: Uncategorized
Uncategorized Operation 40
After
{
  "zip": "75005",
  "city": "Paris",
  "status": "RECRUITING",
  "country": "France",
  "contacts": [
    {
      "name": "Principal Investigator",
      "role": "CONTACT",
      "email": "jean-yves.pierga@curie.fr",
      "phone": "+33 144324680"
    }
  ],
  "facility": "Institut Curie - site de Paris",
  "geoPoint": {
    "lat": 48.85341,
    "lon": 2.3488
  }
}
add /protocolSection/contactsLocationsModule/locations/21
Triage: Uncategorized
Uncategorized Operation 41
After
{
  "zip": "75020",
  "city": "Paris",
  "status": "RECRUITING",
  "country": "France",
  "contacts": [
    {
      "name": "Principal Investigator",
      "role": "CONTACT",
      "email": "joseph.gligorov@aphp.fr",
      "phone": "+33 156016024"
    }
  ],
  "facility": "Hopital Tenon",
  "geoPoint": {
    "lat": 48.85341,
    "lon": 2.3488
  }
}
add /protocolSection/contactsLocationsModule/locations/22
Triage: Uncategorized
Uncategorized Operation 42
After
{
  "zip": "11528",
  "city": "Athens",
  "status": "RECRUITING",
  "country": "Greece",
  "contacts": [
    {
      "name": "Principal Investigator",
      "role": "CONTACT",
      "email": "mdimop@med.uoa.gr",
      "phone": "+30 2103381540"
    }
  ],
  "facility": "General Hospital of Athens &quot;Alexandra&quot;",
  "geoPoint": {
    "lat": 37.98376,
    "lon": 23.72784
  }
}
add /protocolSection/contactsLocationsModule/locations/23
Triage: Uncategorized
Uncategorized Operation 43
After
{
  "zip": "14564",
  "city": "Athens",
  "status": "RECRUITING",
  "country": "Greece",
  "contacts": [
    {
      "name": "Principal Investigator",
      "role": "CONTACT",
      "email": "garavantinos@yahoo.gr",
      "phone": "+30 2108003946"
    }
  ],
  "facility": "General Oncology Hospital of Kifissia &quot; Agioi Anargyroi&quot;",
  "geoPoint": {
    "lat": 37.98376,
    "lon": 23.72784
  }
}
add /protocolSection/contactsLocationsModule/locations/24
Triage: Uncategorized
Uncategorized Operation 44
After
{
  "zip": "15125",
  "city": "Athens",
  "status": "RECRUITING",
  "country": "Greece",
  "contacts": [
    {
      "name": "Principal Investigator",
      "role": "CONTACT",
      "email": "tsiatas@hotmail.com",
      "phone": "+30 2106157392"
    }
  ],
  "facility": "Athens Medical Center",
  "geoPoint": {
    "lat": 37.98376,
    "lon": 23.72784
  }
}
add /protocolSection/contactsLocationsModule/locations/25
Triage: Uncategorized
Uncategorized Operation 45
After
{
  "zip": "71110",
  "city": "Heraklion",
  "status": "RECRUITING",
  "country": "Greece",
  "contacts": [
    {
      "name": "Principal Investigator",
      "role": "CONTACT",
      "email": "mavrudis@med.uoc.gr",
      "phone": "+30 2810392750"
    }
  ],
  "facility": "University General Hospital of Heraklion",
  "geoPoint": {
    "lat": 35.32787,
    "lon": 25.14341
  }
}
add /protocolSection/contactsLocationsModule/locations/26
Triage: Uncategorized
Uncategorized Operation 46
After
{
  "zip": "54645",
  "city": "Thessaloniki",
  "status": "RECRUITING",
  "country": "Greece",
  "contacts": [
    {
      "name": "Principal Investigator",
      "role": "CONTACT",
      "email": "konstantinos.papazisis@gmail.com",
      "phone": "+30 2310895362"
    }
  ],
  "facility": "Euromedica General Clinic Thessaloniki",
  "geoPoint": {
    "lat": 40.64072,
    "lon": 22.93493
  }
}
add /protocolSection/contactsLocationsModule/locations/27
Triage: Uncategorized
Uncategorized Operation 47
After
{
  "zip": "56429",
  "city": "Thessaloniki",
  "status": "RECRUITING",
  "country": "Greece",
  "contacts": [
    {
      "name": "Principal Investigator",
      "role": "CONTACT",
      "email": "desaman@outlook.com",
      "phone": "+30 2313323692"
    }
  ],
  "facility": "General Hospital Papageorgiou",
  "geoPoint": {
    "lat": 40.64072,
    "lon": 22.93493
  }
}
add /protocolSection/contactsLocationsModule/locations/28
Triage: Uncategorized
Uncategorized Operation 48
After
{
  "zip": "57001",
  "city": "Thessaloniki",
  "status": "RECRUITING",
  "country": "Greece",
  "contacts": [
    {
      "name": "Principal Investigator",
      "role": "CONTACT",
      "email": "bakasofia@hotmail.com",
      "phone": "+30 2310239060"
    }
  ],
  "facility": "Interbalkan Hospital of Thessaloniki",
  "geoPoint": {
    "lat": 40.64072,
    "lon": 22.93493
  }
}
add /protocolSection/contactsLocationsModule/locations/30
Triage: Uncategorized
Uncategorized Operation 49
After
{
  "zip": "791-0280",
  "city": "Matsuyama",
  "state": "Ehime",
  "status": "RECRUITING",
  "country": "Japan",
  "contacts": [
    {
      "name": "See Central Contact",
      "role": "CONTACT"
    }
  ],
  "facility": "NHO Shikoku Cancer Center",
  "geoPoint": {
    "lat": 33.83916,
    "lon": 132.76574
  }
}
add /protocolSection/contactsLocationsModule/locations/38
Triage: Uncategorized
Uncategorized Operation 50
After
{
  "zip": "540-0006",
  "city": "Osaka",
  "state": "Osaka",
  "status": "RECRUITING",
  "country": "Japan",
  "contacts": [
    {
      "name": "See Central Contact",
      "role": "CONTACT"
    }
  ],
  "facility": "NHO Osaka National Hospital",
  "geoPoint": {
    "lat": 34.69379,
    "lon": 135.50107
  }
}
add /protocolSection/contactsLocationsModule/locations/39
Triage: Uncategorized
Uncategorized Operation 51
After
{
  "zip": "411-8777",
  "city": "Sunto-gun",
  "state": "Shizuoka",
  "status": "RECRUITING",
  "country": "Japan",
  "contacts": [
    {
      "name": "See Central Contact",
      "role": "CONTACT"
    }
  ],
  "facility": "Shizuoka Cancer Center"
}
add /protocolSection/contactsLocationsModule/locations/43
Triage: Uncategorized
Uncategorized Operation 52
After
{
  "zip": "120-752",
  "city": "Seoul",
  "status": "RECRUITING",
  "country": "South Korea",
  "contacts": [
    {
      "name": "See Central Contact",
      "role": "CONTACT"
    }
  ],
  "facility": "Severance Hospital, Yonsei University Health System",
  "geoPoint": {
    "lat": 37.566,
    "lon": 126.9784
  }
}
add /protocolSection/contactsLocationsModule/locations/44
Triage: Uncategorized
Uncategorized Operation 53
After
{
  "zip": "08003",
  "city": "Barcelona",
  "status": "RECRUITING",
  "country": "Spain",
  "contacts": [
    {
      "name": "Principal Investigator",
      "role": "CONTACT",
      "email": "ITusquets@imas.imim.es",
      "phone": "+34 932483137"
    }
  ],
  "facility": "Hospital del Mar",
  "geoPoint": {
    "lat": 41.38879,
    "lon": 2.15899
  }
}
add /protocolSection/contactsLocationsModule/locations/45
Triage: Uncategorized
Uncategorized Operation 54
After
{
  "zip": "08023",
  "city": "Barcelona",
  "status": "RECRUITING",
  "country": "Spain",
  "contacts": [
    {
      "name": "Principal Investigator",
      "role": "CONTACT",
      "email": "josemanuel.perez@quironsalud.es",
      "phone": "+34 932746085"
    }
  ],
  "facility": "Hospital Quironsalud Barcelona",
  "geoPoint": {
    "lat": 41.38879,
    "lon": 2.15899
  }
}
add /protocolSection/contactsLocationsModule/locations/46
Triage: Uncategorized
Uncategorized Operation 55
After
{
  "zip": "08035",
  "city": "Barcelona",
  "status": "RECRUITING",
  "country": "Spain",
  "contacts": [
    {
      "name": "Principal Investigator",
      "role": "CONTACT",
      "email": "csaura@vhio.net",
      "phone": "+34 932746085"
    }
  ],
  "facility": "Hospital Universitari Vall d&#x27;Hebron",
  "geoPoint": {
    "lat": 41.38879,
    "lon": 2.15899
  }
}
add /protocolSection/contactsLocationsModule/locations/47
Triage: Uncategorized
Uncategorized Operation 56
After
{
  "zip": "28034",
  "city": "Madrid",
  "status": "RECRUITING",
  "country": "Spain",
  "contacts": [
    {
      "name": "Principal Investigator",
      "role": "CONTACT",
      "email": "eholgadomartin@gmail.com; eholgado@oncologiahrc.com",
      "phone": "+34 917567984"
    }
  ],
  "facility": "Hospital Ruber Internacional",
  "geoPoint": {
    "lat": 40.4165,
    "lon": -3.70256
  }
}
add /protocolSection/contactsLocationsModule/locations/48
Triage: Uncategorized
Uncategorized Operation 57
After
{
  "zip": "85186",
  "city": "Sundsvall",
  "status": "RECRUITING",
  "country": "Sweden",
  "contacts": [
    {
      "name": "Principal Investigator",
      "role": "CONTACT",
      "email": "anna-karin.wennstig@rvn.se",
      "phone": "+46 60181000"
    }
  ],
  "facility": "Länssjukhuset Sundsvall-Härnösand",
  "geoPoint": {
    "lat": 62.39129,
    "lon": 17.3063
  }
}
add /protocolSection/contactsLocationsModule/locations/49
Triage: Uncategorized
Uncategorized Operation 58
After
{
  "zip": "75185",
  "city": "Uppsala",
  "status": "RECRUITING",
  "country": "Sweden",
  "contacts": [
    {
      "name": "Principal Investigator",
      "role": "CONTACT",
      "email": "henrik.lindman@igp.uu.se",
      "phone": "+46 1806110000"
    }
  ],
  "facility": "Akademiska Sjukhuset",
  "geoPoint": {
    "lat": 59.85882,
    "lon": 17.63889
  }
}
add /protocolSection/contactsLocationsModule/locations/50
Triage: Uncategorized
Uncategorized Operation 59
After
{
  "zip": "TR1 3LJ",
  "city": "Truro",
  "state": "Cornwall",
  "status": "RECRUITING",
  "country": "United Kingdom",
  "contacts": [
    {
      "name": "Principal Investigator",
      "role": "CONTACT",
      "email": "duncanwheatley@nhs.net",
      "phone": "+44 1872258342"
    }
  ],
  "facility": "Royal Cornwall Hospital",
  "geoPoint": {
    "lat": 50.26526,
    "lon": -5.05436
  }
}
add /protocolSection/contactsLocationsModule/locations/51
Triage: Uncategorized
Uncategorized Operation 60
After
{
  "zip": "NG5 1PB",
  "city": "Nottingham",
  "state": "Nottinghamshire",
  "status": "RECRUITING",
  "country": "United Kingdom",
  "contacts": [
    {
      "name": "Principal Investigator",
      "role": "CONTACT",
      "email": "srinivasan.madhusudan@nottingham.ac.uk",
      "phone": "+44 1158231850"
    }
  ],
  "facility": "Nottingham University Hospitals City Campus",
  "geoPoint": {
    "lat": 52.9536,
    "lon": -1.15047
  }
}
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 5 ops
replace /protocolSection/statusModule/statusVerifiedDate
Triage: Uncategorized
Uncategorized Operation 3
Before
2019-05
After
2019-07
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 6
Before
2019-05-07
After
2019-07-19
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 7
Before
2019-05-09
After
2019-07-23
replace /protocolSection/descriptionModule/briefSummary
Triage: Uncategorized
Uncategorized Operation 9
Before
<p>The reason for this trial is to compare DS-8201a to other treatments being used for HER2-low breast cancer that has spread to other parts of the body.</p><p>DS-8201a is a new medicine for breast cancer that has not been approved yet by the Food and Drug Administration.
It is made of a drug and an antibody.</p><p>Each participant has a 2 out of 3 chance of receiving the new medicine.</p>
After
<p>This study will compare DS-8201a to physician choice standard treatment.</p><p>Participants must have HER2-low breast cancer that has been treated before.</p><p>Participants&#x27; cancer:</p><ul><li>Cannot be removed by an operation</li><li>Has spread to other parts of the body</li></ul>
replace /protocolSection/descriptionModule/detailedDescription
Triage: Uncategorized
Uncategorized Operation 10
Before
<p>This is a randomized, 2-arm, Phase 3, open-label, multicenter study to compare the safety and efficacy of DS8201a versus the physician&#x27;s choice (2:1) in HER2-low, unresectable and&#x2F;or metastatic breast cancer subjects.</p><p>The study is expected to enroll ~360 DS-8201a subjects and ~180 physician&#x27;s choice subjects:</p><ul><li>60 hormone receptor (HR)-negative</li><li>240 HR-positive who have had prior therapy with a cyclin-dependent kinase (CDK) 4&#x2F;6 inhibitor</li><li>240 HR-positive who are naive to treatment with CDK 4&#x2F;6</li></ul><p>There will be approximately 161 sites, including but not limited to, North America, Western Europe, and Asia.</p><p>There are planned follow-up visits after permanent discontinuation of study treatment to obtain information about subsequent treatment(s) and survival status.</p><p>The Sponsor proposes to define a new HER2-low population in this trial including tumors with IHC 1+ and IHC 2+&#x2F;ISH- HER2 expression.</p>
After
<p>This is a randomized, 2-arm, Phase 3, open-label, multicenter study to compare the safety and efficacy of trastuzumab deruxtecan versus the physician&#x27;s choice (2:1) in HER2-low, unresectable and&#x2F;or metastatic breast cancer participants.</p><p>The Sponsor proposes to define a new HER2-low population in this trial including tumors with IHC 1+ and IHC 2+&#x2F;ISH- HER2 expression.</p>
Sponsor and administrative fields Sponsor, collaborator, oversight, or registry maintenance changes. Triage: Uncategorized 3 ops
add /protocolSection/identificationModule/secondaryIdInfos/2
Triage: Uncategorized
Uncategorized Operation 1
After
{
  "id": "DESTINY-B04",
  "type": "OTHER",
  "domain": "Daiichi Sankyo and AstraZeneca"
}
replace /protocolSection/identificationModule/briefTitle
Triage: Uncategorized
Uncategorized Operation 2
Before
DS-8201a Versus Investigator&#x27;s Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]
After
Trastuzumab Deruxtecan (DS-8201a) Versus Investigator&#x27;s Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]
add /protocolSection/sponsorCollaboratorsModule/collaborators
Triage: Uncategorized
Uncategorized Operation 8
After
[
  {
    "name": "Daiichi Sankyo Co., Ltd.",
    "class": "INDUSTRY"
  },
  {
    "name": "AstraZeneca",
    "class": "INDUSTRY"
  }
]
Raw JSON Patch 
[
  {
    "op": "add",
    "path": "/protocolSection/identificationModule/secondaryIdInfos/2",
    "value": {
      "id": "DESTINY-B04",
      "type": "OTHER",
      "domain": "Daiichi Sankyo and AstraZeneca"
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/identificationModule/briefTitle",
    "value": "Trastuzumab Deruxtecan (DS-8201a) Versus Investigator&#x27;s Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2019-07"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "value": "2023-01-01"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "value": "2023-01-01"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2019-07-19"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2019-07-23"
  },
  {
    "op": "add",
    "path": "/protocolSection/sponsorCollaboratorsModule/collaborators",
    "value": [
      {
        "name": "Daiichi Sankyo Co., Ltd.",
        "class": "INDUSTRY"
      },
      {
        "name": "AstraZeneca",
        "class": "INDUSTRY"
      }
    ]
  },
  {
    "op": "replace",
    "path": "/protocolSection/descriptionModule/briefSummary",
    "value": "<p>This study will compare DS-8201a to physician choice standard treatment.</p><p>Participants must have HER2-low breast cancer that has been treated before.</p><p>Participants&#x27; cancer:</p><ul><li>Cannot be removed by an operation</li><li>Has spread to other parts of the body</li></ul>"
  },
  {
    "op": "replace",
    "path": "/protocolSection/descriptionModule/detailedDescription",
    "value": "<p>This is a randomized, 2-arm, Phase 3, open-label, multicenter study to compare the safety and efficacy of trastuzumab deruxtecan versus the physician&#x27;s choice (2:1) in HER2-low, unresectable and&#x2F;or metastatic breast cancer participants.</p><p>The Sponsor proposes to define a new HER2-low population in this trial including tumors with IHC 1+ and IHC 2+&#x2F;ISH- HER2 expression.</p>"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/0/label",
    "value": "Trastuzumab deruxtecan"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/0/description",
    "value": "HER2-low, unresectable, and&#x2F;or metastatic breast cancer participants previously treated with chemotherapy randomized to DS8201a"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/1/description",
    "value": "<p>HER2-low, unresectable, and&#x2F;or metastatic breast cancer participants previously treated with chemotherapy randomized to Physician&#x27;s choice from the following options:</p><ul><li>Capecitabine</li><li>Eribulin</li><li>Gemcitabine</li><li>Paclitaxel</li><li>Nab-paclitaxel</li></ul>"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/description",
    "value": "DS-8201a is a lyophilized powder reconstituted into a sterile aqueous solution (100 mg&#x2F;5 mL) to be administered intravenously"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0",
    "value": "Trastuzumab deruxtecan"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/otherNames/0",
    "value": "DS-8201a"
  },
  {
    "op": "remove",
    "path": "/protocolSection/armsInterventionsModule/interventions/1/otherNames"
  },
  {
    "op": "remove",
    "path": "/protocolSection/armsInterventionsModule/interventions/2/otherNames"
  },
  {
    "op": "remove",
    "path": "/protocolSection/armsInterventionsModule/interventions/3/otherNames"
  },
  {
    "op": "remove",
    "path": "/protocolSection/armsInterventionsModule/interventions/4/otherNames"
  },
  {
    "op": "remove",
    "path": "/protocolSection/armsInterventionsModule/interventions/5/otherNames"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
    "value": "Time from the date of randomization to the earliest date of the first objective documentation of radiographic disease progression via blinded independent central review (BICR) according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1 or death due to any cause."
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
    "value": "Time from the date of randomization to the first objective documentation of radiographic disease progression via investigator assessment according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1 or death due to any cause."
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
    "value": "Time from the date of randomization to the date of death for any cause.\nIf there is no death reported for a participant before the data cutoff for OS analysis, OS will be censored at the last contact date at which the participant is known to be alive."
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
    "value": "Percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR), confirmed by a second assessment."
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
    "value": "Duration of Response (DoR), Based on Blinded Independent Central Review (BICR) and Investigator Assessment"
  },
  {
    "op": "replace",
    "path": "/protocolSection/eligibilityModule/eligibilityCriteria",
    "value": "<p>Inclusion Criteria:</p><ul><li>Is the age of majority in their country</li><li><p>Has pathologically documented breast cancer that:</p><ol><li>Is unresectable or metastatic</li><li>Has low-HER2 expression defined as IHC 2+&#x2F;ISH- or IHC 1+ (ISH- or untested)</li><li>Is HR-positive or HR-negative</li><li>Has progressed on, and would no longer benefit from, endocrine therapy</li><li>Has been treated with 1 to 2 prior lines of chemotherapy&#x2F;adjuvant in the metastatic setting</li><li>Was never previously HER2-positive (ICH 3+ or ISH+) on prior pathology testing (per American Society of Clinical Oncology-College of American Pathologists [ASCO-CAP] guidelines)</li></ol></li><li>Has documented radiologic progression (during or after most recent treatment)</li><li><p>Has adequate archival tumor samples available or is wiling to provide fresh biopsies prior to randomization for:</p><ol><li>assessment of HER2 status</li><li>assessment of post-treatment status</li></ol></li><li>Has at least 1 protocol-defined measurable lesion</li><li>Has protocol-defined adequate cardiac, bone marrow, renal, hepatic and blood clotting functions</li><li>Male and female participants of reproductive&#x2F;childbearing potential, agrees to follow instructions for method(s) of contraception and agrees to avoid preserving ova or sperm for at least 4.5 months after treatment (or longer, per locally approved labels)</li></ul><p>Exclusion Criteria:</p><ul><li>Is ineligible for all options in the physician&#x27;s choice arm</li><li>Has breast cancer ever assessed with high-HER2 expression</li><li>Has previously been treated with any anti-HER2 therapy, including an antibody drug conjugate</li><li>Has uncontrolled or significant cardiovascular disease</li><li>Has spinal cord compression or clinically active central nervous system metastases</li><li>Has history of (noninfectious) interstitial lung disease (ILD)&#x2F;pneumonitis that required steroids, has current ILD&#x2F;pneumonitis, or suspected ILD&#x2F;pneumonitis that cannot be ruled out by imaging at screening</li><li>Has any medical history or condition that per protocol or in the opinion of the investigator is inappropriate for the study</li></ul>"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/1",
    "value": {
      "zip": "90095-1690",
      "city": "Los Angeles",
      "state": "California",
      "status": "RECRUITING",
      "country": "United States",
      "contacts": [
        {
          "name": "Principal Investigator",
          "role": "CONTACT",
          "email": "nmcandrew@mednet.ucla.edu",
          "phone": "210-205-0771"
        }
      ],
      "facility": "UCLA School of Medicine",
      "geoPoint": {
        "lat": 34.05223,
        "lon": -118.24368
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/5",
    "value": {
      "zip": "07039",
      "city": "Livingston",
      "state": "New Jersey",
      "status": "RECRUITING",
      "country": "United States",
      "contacts": [
        {
          "name": "Principal Investigator",
          "role": "CONTACT",
          "email": "anya.litvak@rwjbh.org",
          "phone": "973-322-5200"
        }
      ],
      "facility": "Saint Barnabas Medical Center",
      "geoPoint": {
        "lat": 40.79593,
        "lon": -74.31487
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/6",
    "value": {
      "zip": "10065-6007",
      "city": "New York",
      "state": "New York",
      "status": "RECRUITING",
      "country": "United States",
      "contacts": [
        {
          "name": "Principal Investigator",
          "role": "CONTACT",
          "email": "modis@mskcc.org",
          "phone": "646-888-4564"
        }
      ],
      "facility": "Memorial Sloan Kettering Hospital",
      "geoPoint": {
        "lat": 40.71427,
        "lon": -74.00597
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/7",
    "value": {
      "zip": "97239",
      "city": "Portland",
      "state": "Oregon",
      "status": "RECRUITING",
      "country": "United States",
      "contacts": [
        {
          "name": "Principal Investigator",
          "role": "CONTACT",
          "email": "mitri@ohsu.edu",
          "phone": "503-494-9160"
        }
      ],
      "facility": "Oregon Health &amp; Science University",
      "geoPoint": {
        "lat": 45.52345,
        "lon": -122.67621
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/8",
    "value": {
      "zip": "15219",
      "city": "Pittsburgh",
      "state": "Pennsylvania",
      "status": "RECRUITING",
      "country": "United States",
      "contacts": [
        {
          "name": "Principal Investigator",
          "role": "CONTACT",
          "email": "brufskyam@upmc.edu",
          "phone": "412-641-6500"
        }
      ],
      "facility": "University of Pittsburgh Medical Center Health System",
      "geoPoint": {
        "lat": 40.44062,
        "lon": -79.99589
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/10",
    "value": {
      "zip": "37909",
      "city": "Knoxville",
      "state": "Tennessee",
      "status": "RECRUITING",
      "country": "United States",
      "contacts": [
        {
          "name": "Principal Investigator",
          "role": "CONTACT",
          "email": "rbrig@hcahealthcare.com",
          "phone": "865-549-4107"
        }
      ],
      "facility": "Brig Center for Cancer Care and Survivorship",
      "geoPoint": {
        "lat": 35.96064,
        "lon": -83.92074
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/13",
    "value": {
      "zip": "5020",
      "city": "Salzburg",
      "status": "RECRUITING",
      "country": "Austria",
      "contacts": [
        {
          "name": "Principal Investigator",
          "role": "CONTACT",
          "email": "r.greil@salk.at",
          "phone": "+43 5725557700"
        }
      ],
      "facility": "LKH - Universitätsklinikum der PMU Salzburg",
      "geoPoint": {
        "lat": 47.79941,
        "lon": 13.04399
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/14",
    "value": {
      "zip": "14076",
      "city": "Caen",
      "state": "Calvados",
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