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Study identifier: NCT05812807 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Anatomic Stage II Breast Cancer AJCC v8 · Early Stage Triple-Negative Breast Carcinoma · Anatomic Stage IIIA Breast Cancer AJCC v8  ·  Sponsor: Alliance for Clinical Trials in Oncology

PhasePhase 3
Planned participants1295
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Sara Tolaney, MD  ·  617-632-2335  ·  Sara_Tolaney@dfci.harvard.edu

Laura Hoffman  ·  773-834-2546  ·  lhoffman22@bsd.uchicago.edu

Always discuss trial participation with your own doctor first.

Locations (842)

University of Alabama at Birmingham Cancer CenterBirmingham, Alabama, United StatesActive Not Recruiting
Thomas HospitalFairhope, Alabama, United StatesRecruiting
Mobile Infirmary Medical CenterMobile, Alabama, United StatesRecruiting
University of South Alabama Mitchell Cancer InstituteMobile, Alabama, United StatesRecruiting
Katmai Oncology GroupAnchorage, Alaska, United StatesRecruiting
CTCA at Western Regional Medical CenterGoodyear, Arizona, United StatesRecruiting
Kingman Regional Medical CenterKingman, Arizona, United StatesRecruiting
Cancer Center at Saint Joseph'sPhoenix, Arizona, United StatesRecruiting
Mayo Clinic Hospital in ArizonaPhoenix, Arizona, United StatesRecruiting
Highlands Oncology Group - FayettevilleFayetteville, Arkansas, United StatesRecruiting
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - JonesboroJonesboro, Arkansas, United StatesRecruiting
University of Arkansas for Medical SciencesLittle Rock, Arkansas, United StatesRecruiting

+ 830 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05812807