Alliance A012103
Clinical Trial Title | OptimICE-pCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy with Checkpoint Inhibitor Therapy |
Trial Status | Open to Enrollment |
Start Date | 07/31/2023 |
Location | hospitals |
Trial Type | Cancer - Adult Oncology |
Specific Condition | Breast cancer |
Description | 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. |
Eligibility Criteria | Eligibility Criteria
Please contact Legacy Oncology Research for additional study inclusion/exclusion information.
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IRB Number | Central IRB |
Notes | Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Pembrolizumab - Full Text View - ClinicalTrials.gov |
Principal Investigator | Mei Dong, MD |
Contact Name | Oncology Clinical Research |
Contact Phone | 503-413-8199 |
Contact Fax | 503-413-6920 |
Contact E-Mail | oncologyresearch@lhs.org |