NeoCARD: Anthracycline-Free Neoadjuvant Chemoimmunotherapy in Triple-Negative Breast Cance
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.
| Condition(s) | Triple Negative Breast Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | 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 disease, defined in accordance with current ASCO-CAP HER2 guidelines. 2. Measurable or evaluable tumor in the breast larger than 1 cm, with or without axillary involvement. 3. Patients with multifocal or multicent |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Medical University of South Carolina |
| Locations | Charleston, South Carolina, United States |
| Start date | 2025-10-20 |
| NCT ID | NCT06845319 |
| Official listing | https://clinicaltrials.gov/study/NCT06845319 |