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8110 Gatehouse Road, Falls Church, VA 22042

S1418/BR006, A Randomized, Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer with > 1 cm Residual Invasive Cancer or Positive Lymph Nodes (>pN1mic) After Neoadjuvant Chemotherapy

General Information

Age Group

Adult

Status

Recruiting

Protocol Number

NCT02954874

Background Information

This randomized phase III trial studies how well pembrolizumab works in treating triple-negative breast cancer. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread.

Offered At

Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031
A department of Inova Fairfax Hospital

Eligibility Information

  • Patients must have histologically confirmed estrogen receptor (ER)-, progesterone receptor (PR)- and HER2-negative (triple-negative, TNBC) or ER, PR, and HER2 equivocal status and must not have received and not be planning to receive adjuvant anti-HER2 or endocrine therapies after completion of neoadjuvant chemotherapy; patients who are HER2 positive by American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines are ineligible; HER2 negative and HER2 equivocal cases as per ASCO CAP guidelines that do not receive HER2-targeted therapy are eligible; patients with weekly ER or PR positive disease, defined as ER and/or PR < 5% by immunohistochemistry, are eligible if the treating physician considers the patient not eligible for adjuvant endocrine therapy; residual disease must be >= 1 cm in greatest dimension, and/or have positive lymph nodes (ypN+) observed on pathologic exam
  • Additional eligibility in protocol

Ineligibility Information

  • Patients must not have had prior immunotherapy with anti-PD-L1, anti-PD-1, anti-CTLA4 or similar drugs; patients must not be planning to receive any of the prohibited therapies during the screening or treatment phases of the study
  • Patients must not be planning to receive concomitantly other biologic therapy, hormonal therapy, other chemotherapy, surgery or other anti-cancer therapy except radiation therapy while receiving treatment on this protocol; however, patients receiving extended adjuvant endocrine therapy for an earlier ER positive breast cancer treated with curative intent and without recurrence for at least 5 years may continue with their endocrine therapy
  • Additional ineligibility in protocol

Additional information can be found at https://clinicaltrials.gov/ct2/show/study/NCT02954874?show_locs=Y#contacts?