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
Study on Investigational Medication for Triple-Negative Breast Cancer
Brief description of study.
Detailed description of study
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Triple Receptor-Negative Breast Cancer,Triple-Negative Breast Cancer,Triple Negative Breast Cancer,breast cancer,cancer,oncology
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Age: 18 years - 100 years
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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.
This study investigates the effects of an investigational medication in patients with triple-negative breast cancer (TNBC). Triple-negative breast cancer is a type of cancer that does not have estrogen receptors, progesterone receptors, or HER2 protein, which are common targets in other breast cancer treatments. The purpose of this study is to compare the survival of patients with TNBC who receive the investigational medication after chemotherapy to those who do not, focusing on both the entire study population and a subgroup with a specific protein called PD-L1.
Participants in the study will be randomly assigned to different study arms. One group will receive the investigational medication for one year, while the other group will not receive it. The study will involve procedures such as collecting tumor tissue samples to test for PD-L1, a protein that may affect how the investigational medication works. This will help determine the impact of the medication on the cancer.
- Who can participate: Patients with triple-negative breast cancer having residual disease of at least 1 cm or positive lymph nodes post-chemotherapy are eligible. They must not have metastatic or recurrent disease and should provide tissue samples for testing.
- Study details: Participants will be divided into study arms, with one group receiving the investigational medication and the other not receiving it. A placebo will not be used in this study. Tumor samples will be collected to test for specific proteins.
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