Medical University of South Carolina
This is a single-arm Phase II study to assess the efficacy of a 12-18 week neoadjuvant carboplatin, paclitaxel, and pembrolizumab (CPP) regimen in a response-adaptive manner for triple-negative breast cancer (TNBC) patients who are ineligible for anthracycline-based therapy due to underlying cardiac conditions.
Clinical trial participation among patients with cardiac co-morbidities is limited, creating challenges for oncologists managing aggressive cancers like Triple Negative Breast Cancer (TNBC) in this demographic. At MUSC and its affiliated rural sites, a significant portion of our patient population presents with complex medical histories and co-morbidities that increase their risk for anthracycline-induced cardiotoxicity. Therefore, proposing a dedicated study focused on patients with pre-existing cardiomyopathy or those at high risk for cardiotoxicity-using a non-anthracycline-based regimen-is…
Inclusion Criteria: To be eligible to participate in this study, an individual must meet all of the following criteria: 1. Histologically confirmed triple-negative breast cancer (TNBC) or hormone receptor-low invasive breast carcinoma, with clinical anatomic Stage II or Stage IIIA/B disease as defined by the AJCC 8th Edition Breast Cancer Stating System. a) The invasive tumor must be hormone receptor-negative or low, defined as estrogen receptor (ER) and/or progesterone receptor (PR) staining present in ≤10% of invasive cancer cells by immunohistochemistry (IHC). b) HER2-negative dis…
Carboplatin target AUC 5 every 3 weeks for 12-18 weeks OR target AUC 1.5 every week for 12-18 weeks (per investigator's choice).
80mg/m2 weekly
200 mg every 3 weeks for 4 cycles
Arctuva estimate
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