Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Pembrolizumab

Conditions

• Anatomic Stage II Breast Cancer AJCC v8
• Anatomic Stage IIIA Breast Cancer AJCC v8
• Anatomic Stage IIIB Breast Cancer AJCC v8
• Early Stage Triple-Negative Breast Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pembrolizumab — BIOLOGICAL
  Given IV
• Patient Observation — OTHER
  Undergo observation
• Biopsy — PROCEDURE
  Undergo biopsy
• Biospecimen Collection — PROCEDURE
  Undergo collection of blood
• Questionnaire Administration — OTHER
  Ancillary studies
• Quality-of-Life Assessment — OTHER
  Ancillary studies

Study Details

This phase III trial compares the effect of continuation of treatment with pembrolizumab (usual approach) to observation only at preventing cancer from coming back in patients with early-stage triple-negative breast cancer (TNBC) who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. The usual approach for patients with early-stage TNBC who receive preoperative chemotherapy plus pembrolizumab is to continue to receive pembrolizumab for up to 27 weeks after surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial may help researchers determine if observation is as good as receiving pembrolizumab for 27 weeks after surgery in triple-negative breast cancer patients who achieved a pathologic complete response after preoperative treatment with chemotherapy and pembrolizumab.

Key Dates

Start date

Jun 14, 2023

Status verified

Jun 2026

Primary completion

May 31, 2033

Completion

May 31, 2033

Study Design

Enrollment

1,295 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm I (pembrolizumab)
  Patients receive pembrolizumab IV over 25-40 minutes Q3W or Q6W for 27 weeks. Patients also undergo tumor biopsy and collection of blood throughout the study. Patients also undergo mammography, breast ultrasound or MRI and during follow-up.
• Experimental: Arm II (observation)
  Patients undergo observation for 27 weeks. Patients also undergo tumor biopsy and collection of blood throughout the study. Patients also undergo mammography, breast ultrasound or MRI during follow-up.

Primary Outcome Measure

Recurrence-free survival (RFS) [ Time Frame: Up to 10 years. ]

Central Contacts

• Sara Tolaney, MD
  617-632-2335
  [email protected]
• Laura Hoffman
  773-834-2546
  [email protected]

Locations (820)