Site for OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy with Checkpoint Inhibitor Therapy
Brief description of study
Site for OptimICE-pCR is a randomized phase III trial that is enrolling early-stage TNBC patients with a pCR after the completion of neoadjuvant therapy consisting of a minimum of 6 cycles of chemotherapy in combination with an ICI. Patients are randomized 1:1 to receive 27 weeks of adjuvant pembrolizumab or observation. Schedule of pembrolizumab is per physician’s choice, with a choice of either pembrolizumab 200 mg IV administered on day 1 of each 21-day cycle or 400 mg IV administered on day 1 of every 42-day cycle. If every 42 day (6 week dosing) is chosen, then 4 doses of 400 mg IV every 42 days can be administered followed by one cycle of 200 mg IV every 21 days, so that a total of 27 weeks of pembrolizumab is received.
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