The phase III trial compares the effect of pembrolizumab to observation for the treatment of patients with early-stage triple-negative breast cancer who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial may help researchers determine if observation will result in the same risk of cancer coming back as pembrolizumab after surgery in triple-negative breast cancer patients who achieve pathologic complete response after preoperative chemotherapy with pembrolizumab.
Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Pembrolizumab
OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy With Checkpoint Inhibitor Therapy
Breast cancer
All genders
18+
Recruiting now
Overview
Principal Investigator: Ilana Schlam
Contact Us
Latoya Lashley
Study details
Inclusion Criteria
- 1. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- 2. Triple Negative Breast Cancer
- 3. Patients must have received neoadjuvant chemotherapy in combination with pembrolizumab for a minimum of 6 cycles.
Exclusion Criteria
- 1. No stage IV (metastatic) breast cancer
- 2. No history of any prior (ipsi- or contralateral) invasive breast cancer. Prior DCIS is allowed
- 3. No evidence of recurrent disease following preoperative therapy and surgery
Study Requirements
Patients are randomized to 1 of 2 arms after completing neoadjuvant chemotherapy in combination with pembrolizumab, followed by definitive breast surgery. ARM I (PEMBROLIZUMAB): Patients receive pembrolizumab intravenously (IV) on study. Patients also undergo tumor biopsy on study, and collection of blood on study and during follow-up. ARM II (OBSERVATION): Patients undergo observation on study. Patients also undergo tumor biopsy on study, and collection of blood on study and during follow-up.