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

Recruiting Phase 3 Interventional Study
Anatomic Stage II Breast Cancer AJCC v8 Early Stage Triple-Negative Breast Carcinoma Anatomic Stage IIIA Breast Cancer AJCC v8 Anatomic Stage IIIB Breast Cancer AJCC v8
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About This Trial
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 r…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Age \>= 18 years * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 * Triple Negative Breast Cancer: * Patients with a history of clinical stage T1cN1-2 or T2-4N0-2 (clinical stage II or III prior to preoperative therapy) breast cancer at time of diagnosis a…
Contacts

Sara Tolaney, MD

617-632-2335

Sara_Tolaney@dfci.harvard.edu

CONTACT

Laura Hoffman

773-834-2546

lhoffman22@bsd.uchicago.edu

CONTACT