A012103: OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy with Checkpoint Inhibitor Therapy
Objective
Primary objective: To compare quality of life (QOL) at approximately 27 weeks as assessed by the FACT-B Trial Outcome Index between patients randomized to adjuvant pembrolizumab versus observation. Hypothesis: QOL will be non-inferior in the pembrolizumab arm compared to the observation arm. Exploratory objectives: To describe trajectories of QOL over time among patients randomized to adjuvant pembrolizumab vs. observation To compare various QOL domains after approximately 27 weeks as assessed by the 5 subscales of the FACT-B Index between patients randomized to adjuvant pembrolizumab versus observation. This analysis is exploratory, though we anticipate the direction of the comparisons to be consistent with Primary and Secondary Hypotheses. To compare self-reported symptomatic adverse events as outlined in section 14.1.1 after approximately 27 weeks of the study assessed by the PRO-CTCAE between patients randomized to adjuvant pembrolizumab versus observation. This analysis is exploratory in nature.
