This study focuses on patients who have been diagnosed with early-stage, triple-negative breast cancer (TNBC) and have recently completed preoperative chemotherapy in combination with the immunotherapy drug pembrolizumab, followed by breast surgery. The purpose of the study is to determine whether observation is as effective as continuation of pembrolizumab postoperatively for treating TNBC breast cancer. The usual approach for patients with early-stage TNBC who receive preoperative chemotherapy plus pembrolizumab is to continue to receive pembrolizumab for up to 27 weeks (total of 1 year) after surgery. Researchers aim to compare the effectiveness of up to 27 weeks of post-surgical observation to up to 27 weeks of post-surgery pembrolizumab at reducing the risk of breast cancer returning or death in these patients, who achieved a pathologic complete response (no remaining invasive cancer found) after preoperative chemotherapy in combination with pembrolizumab. Pembrolizumab works by helping the immune system to fight cancer and is approved by the U.S. Food and Drug Administration. Participants will be randomly assigned to 1 of 2 groups. Group 1 will receive 27 weeks of pembrolizumab treatment after breast surgery; Group 2 will be observed by the study doctors and will not receive pembrolizumab.
What is the full name of this clinical trial?
A012103: OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy with Checkpoint Inhibitor Therapy
Andrew Horodner, Benjamin King, David Chan, Dorothy Park, Hugo Hool, Jin Sun Bitar, Johnny Chang, Julie Huynh, Marc Botnick, Maryliza El-Masry, Monica Mita, Natasha Banerjee, Philomena McAndrew, Robert Reznik, Ryan Ponec, Swati Sikaria, Syed Jilani, Thomas Lowe, Vanessa Dickey