A Phase III, Randomized, Double-blind Study to Evaluate Pembrolizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy for Triple Negative Breast Cancer (TNBC)

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Record identity and dates

Source

ClinicalTrials.gov

Source record ID

NCT03036488

Title field or adapter rule

{'original_value': 'A Phase III, Randomized, Double-blind Study to Evaluate Pembrolizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy for Triple Negative Breast Cancer (TNBC)', 'source_field': 'protocolSection.identificationModule.officialTitle'}

Ingested At

2026-10-31T23:27:30.432596+00:00

Published At

2026-10-22T00:00:00+00:00

Record Updated At

2026-10-22

Results Posted At

2026-10-22

Source Retrieved At

2026-10-31T22:18:22.973355+00:00

Timestamp Basis

ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter

Date limitation

ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter

Fields recorded by this source

protocolSection.conditionsModule.conditions

["Triple Negative Breast Neoplasms"]

protocolSection.statusModule.lastUpdatePostDateStruct

{"date": "2026-10-22", "type": "ACTUAL"}

protocolSection.identificationModule.nctId

"NCT03036488"

protocolSection.identificationModule.officialTitle

"A Phase III, Randomized, Double-blind Study to Evaluate Pembrolizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy for Triple Negative Breast Cancer (TNBC)"

protocolSection.statusModule.overallStatus

"COMPLETED"

protocolSection.designModule.phases

["PHASE3"]

protocolSection.statusModule.resultsFirstPostDateStruct

{"date": "2026-10-22", "type": "ACTUAL"}

Study condition terms

• Triple Negative Breast Neoplasms (protocolSection.conditionsModule.conditions)

Interventions recorded in this study

• {'armGroupLabels': ['Pembrolizumab + Chemotherapy'], 'description': 'On Day 1 of each cycle in the neoadjuvant and adjuvant phases of the study for a total of 17 cycles; intravenous (IV) infusion.', 'name': 'Pembrolizumab', 'type': 'BIOLOGICAL'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['Pembrolizumab + Chemotherapy', 'Placebo + Chemotherapy'], 'description': 'On Day 1 of Cycles 1-4 of the neoadjuvant phase of the study OR on Days 1, 8, 15 of Cycles 1-4 of the neoadjuvant phase of the study; IV infusion.', 'name': 'Carboplatin', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['Pembrolizumab + Chemotherapy', 'Placebo + Chemotherapy'], 'description': 'On Days 1, 8 and 15 of Cycles 1-4 in the neoadjuvant phase of the study; IV infusion.', 'name': 'Paclitaxel', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['Pembrolizumab + Chemotherapy', 'Placebo + Chemotherapy'], 'description': 'On Day 1 of Cycles 5-8 of the neoadjuvant phase of the study; IV injection.', 'name': 'Doxorubicin', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['Pembrolizumab + Chemotherapy', 'Placebo + Chemotherapy'], 'description': 'On Day 1 of Cycles 5-8 of the neoadjuvant phase of the study; IV injection.', 'name': 'Epirubicin', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['Pembrolizumab + Chemotherapy', 'Placebo + Chemotherapy'], 'description': 'On Day 1 of Cycles 5-8 of the neoadjuvant phase of the study; IV infusion.', 'name': 'Cyclophosphamide', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['Placebo + Chemotherapy'], 'description': 'normal saline solution or dextrose: On Day 1 of each cycle in the neoadjuvant and adjuvant phases of the study for a total of 17 cycles; IV infusion', 'name': 'Placebo', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['Pembrolizumab + Chemotherapy', 'Placebo + Chemotherapy'], 'description': 'For prevention of neutropenia, filgrastim 5 μg/kg/day via subcutaneous (SC) injection administered per standard of care after chemotherapy OR pegfilgrastim 100 µg/kg (individualized) or 6 mg (general approach) via SC injection administered per standard of care.', 'name': 'Granulocyte colony stimulating factor: Filgrastim or Pegfilgrastim', 'type': 'BIOLOGICAL'} (protocolSection.armsInterventionsModule.interventions[])

An intervention appearing in a study record does not establish an effect or an approved use.

Drug names recorded in this source

• Carboplatin (protocolSection.armsInterventionsModule.interventions[].name)
• Paclitaxel (protocolSection.armsInterventionsModule.interventions[].name)
• Doxorubicin (protocolSection.armsInterventionsModule.interventions[].name)
• Epirubicin (protocolSection.armsInterventionsModule.interventions[].name)
• Cyclophosphamide (protocolSection.armsInterventionsModule.interventions[].name)
• Placebo (protocolSection.armsInterventionsModule.interventions[].name)

A recorded drug name is not by itself an indication or a condition-specific relationship.

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