RecruitingAnatomic Stage II Breast Cancer AJCC v8Early Stage Triple-Negative Breast CarcinomaAnatomic Stage IIIA Breast Cancer AJCC v8

Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Pembrolizumab

Eligible age

18+ yrs

Accepts

All genders

Locations

49 states

Healthy volunteers

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About this study

This phase III trial compares the effect of continuation of treatment with pembrolizumab (usual approach) to observation only at preventing cancer from coming back in patients with early-stage triple-negative breast cancer (TNBC) who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. The usual approach for patients with early-stage TNBC who receive preoperative chemotherapy plus pembrolizumab is to continue to receive pembrolizumab for up to 27 weeks after surgery. 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 is as good as receiving pembrolizumab for 27 weeks after surgery in triple-negative breast cancer patients who achieved a pathologic complete response after preoperative treatment with chemotherapy and pembrolizumab.

Sponsor: Alliance for Clinical Trials in Oncology

You may qualify if…

✓ Age \>= 18 years
✓ Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
✓ Triple Negative Breast Cancer:
✓ Patients with a history of clinical stage T1cN1-2 or T2-4N0-2 (clinical stage II or III prior to preoperative therapy) breast cancer at time of diagnosis 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 ductal carcinoma in situ (DCIS) is allowed. Isolated tumor cells are considered node-negative
✓ Estrogen receptor (ER) and progesterone receptor (PR) =\< 10%; HER2-negative by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines (immunohistochemistry \[IHC\] and fluorescence in situ hybridization \[FISH\])
✓ If invasive disease was present in both breasts, participation in the study is permitted as long as the eligibility criteria are met for both tumors/breasts
✓ Patients must have received neoadjuvant chemotherapy in combination with pembrolizumab for a minimum of 6 cycles. All systemic chemotherapy must have been completed preoperatively

You may not qualify if…

✕ No stage IV (metastatic) breast cancer
✕ No history of any prior (ipsi- or contralateral) invasive breast cancer. Prior DCIS is allowed
✕ No evidence of recurrent disease following preoperative therapy and surgery
✕ No known active liver disease, e.g. due to hepatitis B virus (HBV), hepatitis C virus (HCV), autoimmune hepatic disorders, or sclerosing cholangitis
✕ No history of intolerance, including Grade 3 or 4 infusion reaction or hypersensitivity to pembrolizumab or murine proteins or any components of the product
✕ \* Note: Prior immune-related adverse events (irAEs) are allowed if they resolved to ≤ grade 1 and the patient tolerated subsequent therapy without requiring chronic steroids for the irAE. The following are exceptions to this criterion: Grade 2 or lower immune mediated endocrinopathies due to neoadjuvant checkpoint inhibition but patients are stable on endocrine therapy and were able to continue checkpoint inhibition.
✕ No medical conditions that require chronic systemic steroids (\>10 mg prednisone daily or equivalent) or any other form of immunosuppressive medications and has required such therapy in the last two years. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic therapy
✕ Patients who are unable or unwilling to comply with the requirements of the protocol per investigator assessment are not eligible