A Randomized Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer With ? 1 CM Residual Invasive Cancer or Positive Lymph Nodes (ypN+) After Neoadjuvant Chemotherapy

T
Tarah Ballinger, MD

Primary Investigator

Overview

This randomized phase III trial studies how well pembrolizumab works in treating patients with triple-negative breast cancer.

Description

The purpose of this study is to compare invasive disease-free survival (IDFS) of patients with triple-negative breast cancer (TNBC) who have either >= 1 cm residual invasive breast cancer and/or positive lymph nodes (> ypN+) after neoadjuvant chemotherapy randomized to receive 1 year of MK-3475 (pembrolizumab) adjuvant therapy compared to no MK-3475 (pembrolizumab), in both the entire study population and also in the PD-L1 positive subset.

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    breast cancer
  • Age: Between 18 Years - 100 Years
  • Gender: All

Inclusion Criteria
In order to be eligible to take part in this trial, patients must meet the following criteria:

  • 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 NOTE: Immunohistochemistry (IHC)-positive isolated tumor cells in the lymph node (N0 [i+]) are not considered node-positive and these patients also must have >= 1 cm residual invasive cancer in the breast in order to be eligible.
  • Patients must not have metastatic disease (i.e., must be M0); patients must not have locally recurrent disease.
  • Patients must have a minimum of five, available unstained slides from the residual (post-neoadjuvant) invasive tumor in primary site or lymph node; (these will be submitted to determine PD-L1 expression) the tumor tissue must be adequate for PD-L1 testing, which typically requires a minimum of 100 cancer cells per slide.

For a full list of participation criteria, please visit clinicaltrials.gov.


Additional Information:
Participants will not be paid for their participation.

Updated on 20 Nov 2022. Study ID: 1804152100 (S1418/BR006)

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