A012103

Official Title

OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy with Checkpoint Inhibitor Therapy

 

 

Study Purpose

To evaluate whether observation results in a non-inferior recurrence free survival compared to adjuvant pembrolizumab in early-stage TNBC patients who achieve a pathological complete response after neoadjuvant chemotherapy with pembrolizumab

 

Diagnosis

TNBC=Triple Negative Breast Cancer (hormone negative and HER2 negative) pCR=pathological complete response (no cancer identified in surgical specimen) after chemotherapy treatment then surgery

Eligibility

Triple Negative Breast Cancer

 

Patients with a history of stage T1cN1-2 or T2-4N0-2 breast cancer according to the primary tumor-regional lymph node anatomic staging criteria as determined by the investigator in radiologic assessment, clinical assessment or both.

 

Patients must have no residual invasive disease in the breast or lymph nodes after the completion of neoadjuvant therapy and then surgery.

 

ER and PR ≤10%; HER2-negative

Intervention

Pembrolizumab versus Observation