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

  • Age ≥ 18 years
  • ECOG Performance Status 0-2
  • 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 of the American Joint Committee on Cancer (AJCC), 8th edition 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. Residual DCIS is allowed. Isolated tumor cells are considered node-negative.
  •     ER and PR ≤10%; HER2-negative by ASCO/CAP guidelines (IHC and FISH)
  • Patients must have received neoadjuvant chemotherapy in combination with pembrolizumab for a minimum of 6 cycles. All systemic chemotherapy must have been completed preoperatively.
  • An interval of no more than 12 weeks between the completion date of the final surgery and the date of randomization.
  • Use of investigational anti-cancer agents must be discontinued at time of registration.

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.


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 -
Principal Investigator Mei Dong, MD
Contact Name Oncology Clinical Research
Contact Phone 503-413-8199
Contact Fax 503-413-6920
Contact E-Mail