| NCT#: | NCT05812807 |
| NCT QR Code |  |
| Title: | OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy With Checkpoint Inhibitor Therapy |
| Protocol: | A012103 |
| Cancer Type | Breast |
| Study Sponsor: | Alliance/NCI |
| Brief Summary: | 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. |
| Study Type: | Interventional |
| Date Opened at SVH: | August 3, 2023 |
| Recruitment Status: | Recruiting |
| Study Population: | |
| Eligibility Criteria: | See SCHEMA |
| Principal Investigator: | Geetha N. Varma, MD, Oncology, Salinas Valley Health Cancer Care, (831) 755-1701 |
| Participating Institution: | Salinas Valley Health |
| Salinas Valley Health Clinical Research Program: | Terri Nielsen, MSJ, RN, CCRP, Clinical Research Program Manager, [email protected] |
| Link to ClinicalTrials.gov | https://classic.clinicaltrials.gov/ct2/show/NCT05812807?term=NCT05812807&draw=2&rank=1 |
| Schema | Schema |
(Tumor Board) & Other Clinical Trials at Salinas Valley Health
