NeoCARD: Anthracycline-Free Neoadjuvant Chemoimmunotherapy in Triple-Negative Breast Cancer Patients (NCT06845319) | Clinical Trial Compass
RecruitingPhase 2
NeoCARD: Anthracycline-Free Neoadjuvant Chemoimmunotherapy in Triple-Negative Breast Cancer Patients
United States43 participantsStarted 2025-10-20
Plain-language 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
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Measurable or evaluable tumor in the breast larger than 1 cm, with or without axillary involvement.
✓. Patients with multifocal or multicentric disease are eligible, provided the dominant tumor focus is ER and/or PR ≤10% and HER2 negative.
✓. Female or male, age ≥18 years.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
✓. Medically fit to undergo curative-intent breast surgery per institutional standard of care.
✓. No prior chemotherapy, immunotherapy, radiation therapy, or surgery for the current breast cancer (diagnostic core or vacuum-assisted biopsies allowed).
✓. Ability to be followed by a cardiologist and/or primary care physician for optimization of cardiac comorbidities, as needed.
Exclusion criteria
✕. Subject is planning to participate, currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
✕. Current diagnosis of metastatic or inflammatory breast cancer.
✕. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy (7-day clearance period for immunosuppressant therapy prior to starting study treatment, if applicable).