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NCT03414684

Carboplatin +/- Nivolumab in Metastatic Triple Negative Breast Cancer

Version 17 to 18 · Dana-Farber Cancer Institute

Patch inspector

Version 17 to 18

31 operations 3 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
primary_outcome_any_changesecondary_outcome_any_change
Value signals

None recorded.

Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 19:11:22+00
Raw hash
a923c8d0708cf63110457801dbbcf184629bc55b1a76f918e915cf0f8115855a
Payload
Source URL
Primary outcomes Outcome measures that define the trial's primary evidence target. Triage: Critical 3 ops
replace /protocolSection/outcomesModule/primaryOutcomes/0/measure
Triage: Critical
Primary Outcome Change Operation 4
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
Progression-free survival (PFS)
After
Progression-free survival
replace /protocolSection/outcomesModule/primaryOutcomes/0/description
Triage: Critical
Primary Outcome Change Operation 5
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
To compare the efficacy of carboplatin in combination with nivolumab versus carboplatin alone, as defined by progression-free survival (PFS), as first-line therapy in the metastatic setting for patients with unselected (by PD-L1 status)metastatic TNBC.
After
Defined as the time from randomization (or registration) to the earlier of progression or death due to any cause.
Participants alive without disease progression are censored at date of last disease evaluation
replace /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame
Triage: Critical
Primary Outcome Change Operation 6
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
2 years
After
3.5 years
Secondary outcomes Additional endpoints and outcome descriptions. Triage: High 25 ops
replace /protocolSection/outcomesModule/secondaryOutcomes/0/measure
Triage: High
Secondary Outcome Change Operation 7
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Overall Response Rate
After
Objective response rate by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1
replace /protocolSection/outcomesModule/secondaryOutcomes/0/description
Triage: High
Secondary Outcome Change Operation 8
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
To compare the efficacy of carboplatin in combination with nivolumab versus carboplatin alone, as defined by overall response rate (ORR) according to RECIST 1.1 and immune-related response criteria (irRC), in patients with unselected metastatic TNBC.
After
Defined as the proportion of patients achieving a complete response (complete disappearance of all target and non-target lesions; no new lesions) or partial response (at least 30% decrease in the sum of the diameters of target lesions; persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits [i.e., "non-CR/non-PD" in non-target lesions]; and no new lesions) based on RECIST 1.1
replace /protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame
Triage: High
Secondary Outcome Change Operation 9
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
2 years
After
3.5 years
replace /protocolSection/outcomesModule/secondaryOutcomes/1/measure
Triage: High
Secondary Outcome Change Operation 10
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Overall Survival
After
Objective response rate by Immune-Related Response Criteria (irRC)
replace /protocolSection/outcomesModule/secondaryOutcomes/1/description
Triage: High
Secondary Outcome Change Operation 11
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
To compare the efficacy of carboplatin in combination with nivolumab versus carboplatin alone, as defined by overall survival (OS), in patients with unselected metastatic TNBC.
After
Defined as the proportion of patients achieving an immune-related complete response (complete disappearance of all target and non-target lesions; no new measurable/unmeasurable lesions) or immune-related partial response (a decrease of the immune-related sum of product diameters [irSPD] of 50% or greater) based on irRC
replace /protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame
Triage: High
Secondary Outcome Change Operation 12
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
2 years
After
3.5 years
replace /protocolSection/outcomesModule/secondaryOutcomes/2/measure
Triage: High
Secondary Outcome Change Operation 13
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Clinical Benefit Rate
After
Overall survival
replace /protocolSection/outcomesModule/secondaryOutcomes/2/description
Triage: High
Secondary Outcome Change Operation 14
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
To compare the efficacy of carboplatin in combination with nivolumab versus carboplatin alone, as defined by clinical benefit rate (CBR) according to RECIST 1.1, in patients with unselected metastatic TNBC.
After
Defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive
replace /protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame
Triage: High
Secondary Outcome Change Operation 15
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
2 years
After
3.5 years
replace /protocolSection/outcomesModule/secondaryOutcomes/3/measure
Triage: High
Secondary Outcome Change Operation 16
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Duration of Response
After
Clinical benefit rate
replace /protocolSection/outcomesModule/secondaryOutcomes/3/description
Triage: High
Secondary Outcome Change Operation 17
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
To evaluate the duration of response (DOR) of carboplatin in combination with nivolumab versus carboplatin alone, in patients with unselected metastatic TNBC.
After
Defined as the proportion of patients achieving a complete response or partial response by RECIST 1.1, or stable disease lasting greater than or equal to 24 weeks
replace /protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame
Triage: High
Secondary Outcome Change Operation 18
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
2 years
After
3.5 years
replace /protocolSection/outcomesModule/secondaryOutcomes/4/measure
Triage: High
Secondary Outcome Change Operation 19
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Time to Objective Response
After
Duration of response
replace /protocolSection/outcomesModule/secondaryOutcomes/4/description
Triage: High
Secondary Outcome Change Operation 20
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
To evaluate the time to objective response (TTOR) of carboplatin in combination with nivolumab versus carboplatin alone, in patients with unselected metastatic TNBC.
After
Defined as the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented.
Patients without events reported are censored at the last disease evaluation
replace /protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame
Triage: High
Secondary Outcome Change Operation 21
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
2 years
After
3.5 years
replace /protocolSection/outcomesModule/secondaryOutcomes/5/measure
Triage: High
Secondary Outcome Change Operation 22
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
BRCA carriers
After
Time to objective response
replace /protocolSection/outcomesModule/secondaryOutcomes/5/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
To explore the efficacy of carboplatin alone or in combination with nivolumab, as defined by progression free survival (PFS), for metastatic TNBC in patients with germline BRCA1 or BRCA2 mutations.
After
Defined as the time from registration to the date of the first documented CR or PR by RECIST 1.1, whichever is first recorded
replace /protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame
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
2 years
After
3.5 years
replace /protocolSection/outcomesModule/secondaryOutcomes/6/measure
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
Incidence Rate of each Toxicity (safety and tolerability)
After
Efficacy among PD-L1-positive patients
replace /protocolSection/outcomesModule/secondaryOutcomes/6/description
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
To evaluate the safety and tolerability of carboplatin in combination with nivolumab, and compare to that of carboplatin alone, in patients with metastatic TNBC previously treated with 0 to 1 line of chemotherapy in the metastatic setting.
After
PFS, ORR according to RECIST 1.1 and irRC, CBR, DOR, TTOR and OS, among patients with PD-L1-positive disease, defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1 (all efficacy endpoints defined as above in outcomes 1-7)
replace /protocolSection/outcomesModule/secondaryOutcomes/6/timeFrame
Triage: High
Secondary Outcome Change Operation 27
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
2 years
After
3.5 years
replace /protocolSection/outcomesModule/secondaryOutcomes/7/measure
Triage: High
Secondary Outcome Change Operation 28
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Incidence Rate of each Toxicity (safety and tolerability) for crossover patients
After
Efficacy among BRCA-mutant patients
replace /protocolSection/outcomesModule/secondaryOutcomes/7/description
Triage: High
Secondary Outcome Change Operation 29
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
• To evaluate the safety and tolerability of nab-paclitaxel in combination with nivolumab, as second-line therapy in patients with metastatic TNBC who crossover after progression on carboplatin alone.
After
PFS, ORR according to RECIST 1.1 and irRC, CBR, DOR, TTOR and OS, among patients with germline BRCA1 or BRCA2 mutations (all efficacy endpoints defined as above in outcomes 1-7)
replace /protocolSection/outcomesModule/secondaryOutcomes/7/timeFrame
Triage: High
Secondary Outcome Change Operation 30
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
2 years
After
3.5 years
add /protocolSection/outcomesModule/secondaryOutcomes/8
Triage: High
Secondary Outcome Change Operation 31
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
{
  "measure": "Efficacy of nab-paclitaxel during second-course therapy, among crossover patients",
  "timeFrame": "3.5 years",
  "description": "PFS, ORR according to RECIST 1.1 and irRC, CBR, DOR, TTOR and OS among patients who crossover to receive nab-paclitaxel + nivolumab + carboplatin after progression on carboplatin alone (all efficacy endpoints defined as above in outcomes 1-7)"
}
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 3 ops
replace /protocolSection/statusModule/statusVerifiedDate
Triage: Uncategorized
Uncategorized Operation 1
Before
2022-09
After
2022-10
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 2
Before
2022-09-19
After
2022-10-03
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 3
Before
2022-09-21
After
2022-10-05
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2022-10"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2022-10-03"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2022-10-05"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
    "value": "Progression-free survival"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
    "value": "Defined as the time from randomization (or registration) to the earlier of progression or death due to any cause.\nParticipants alive without disease progression are censored at date of last disease evaluation"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
    "value": "3.5 years"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
    "value": "Objective response rate by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
    "value": "Defined as the proportion of patients achieving a complete response (complete disappearance of all target and non-target lesions; no new lesions) or partial response (at least 30% decrease in the sum of the diameters of target lesions; persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits [i.e., "non-CR/non-PD" in non-target lesions]; and no new lesions) based on RECIST 1.1"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
    "value": "3.5 years"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
    "value": "Objective response rate by Immune-Related Response Criteria (irRC)"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
    "value": "Defined as the proportion of patients achieving an immune-related complete response (complete disappearance of all target and non-target lesions; no new measurable/unmeasurable lesions) or immune-related partial response (a decrease of the immune-related sum of product diameters [irSPD] of 50% or greater) based on irRC"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
    "value": "3.5 years"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
    "value": "Overall survival"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
    "value": "Defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
    "value": "3.5 years"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
    "value": "Clinical benefit rate"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/description",
    "value": "Defined as the proportion of patients achieving a complete response or partial response by RECIST 1.1, or stable disease lasting greater than or equal to 24 weeks"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
    "value": "3.5 years"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/4/measure",
    "value": "Duration of response"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/4/description",
    "value": "Defined as the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented.\nPatients without events reported are censored at the last disease evaluation"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame",
    "value": "3.5 years"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/5/measure",
    "value": "Time to objective response"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/5/description",
    "value": "Defined as the time from registration to the date of the first documented CR or PR by RECIST 1.1, whichever is first recorded"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame",
    "value": "3.5 years"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/6/measure",
    "value": "Efficacy among PD-L1-positive patients"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/6/description",
    "value": "PFS, ORR according to RECIST 1.1 and irRC, CBR, DOR, TTOR and OS, among patients with PD-L1-positive disease, defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1 (all efficacy endpoints defined as above in outcomes 1-7)"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/6/timeFrame",
    "value": "3.5 years"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/7/measure",
    "value": "Efficacy among BRCA-mutant patients"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/7/description",
    "value": "PFS, ORR according to RECIST 1.1 and irRC, CBR, DOR, TTOR and OS, among patients with germline BRCA1 or BRCA2 mutations (all efficacy endpoints defined as above in outcomes 1-7)"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/7/timeFrame",
    "value": "3.5 years"
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/8",
    "value": {
      "measure": "Efficacy of nab-paclitaxel during second-course therapy, among crossover patients",
      "timeFrame": "3.5 years",
      "description": "PFS, ORR according to RECIST 1.1 and irRC, CBR, DOR, TTOR and OS among patients who crossover to receive nab-paclitaxel + nivolumab + carboplatin after progression on carboplatin alone (all efficacy endpoints defined as above in outcomes 1-7)"
    }
  }
]