A012103: OPTIMICE-PCR Trial — Reducing Therapy Intensity in Triple-Negative Breast Cancer After a Complete Response

Study Overview:
This trial focuses on patients with early-stage triple-negative breast cancer (TNBC) who have achieved a pathologic complete response (pCR) after chemotherapy plus pembrolizumab. The study compares close monitoring after surgery versus continuing pembrolizumab treatment for up to 27 weeks to determine whether additional therapy is necessary.

Key Study Details:

  • Phase & Design: Randomized interventional

  • Population: Early-stage TNBC patients with confirmed pCR

  • Treatment Arms: Observation only vs. continued pembrolizumab

  • Primary Objective: Evaluate recurrence-free survival

  • Why It Matters: Avoiding unnecessary treatment reduces toxicity, costs, and long-term side effects.