OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy with Checkpoint Inhibitor Therapy

This study is being done to answer the following question: Among patients with early-stage triple-negative breast cancer (TNBC) who achieve a pathologic complete response (pCR) after preoperative chemotherapy in combination with pembrolizumab, will observation after surgery be as effective as completing 6 more months of pembrolizumab after surgery at preventing cancer from coming back? This study aims to find out if observation is as good as the usual approach for early-stage TNBC. The usual approach for patients with early-stage TNBC who receive preoperative chemotherapy plus pembrolizumab is to continue to receive FDA-approved pembrolizumab for up to 27 weeks after surgery.

Are you Eligible? (Inclusion Criteria)

• Are you 18 years of age or older? Have you recently completed treatment of triple-negative breast cancer (TNBC), involving preoperative chemotherapy in combination with pembrolizumab, followed by breast surgery, and the treatment resulted in a pathologic complete response (meaning that no remaining cancer was found during your breast surgery)? Are you willing to make regularly scheduled visits to the clinic for treatment and evaluation, including completing questionnaires?