Study Comparing Nab-paclitaxel Plus Carboplatin and Nab-paclitaxel Plus Epirubicin as Pre-Surgery Treatment for Triple-Negative Breast Cancer in Women Aged 18 to 70

What this Trial Is About

Researchers are evaluating treatments for triple-negative breast cancer TNBC, a type of breast cancer that lacks estrogen and progesterone receptors and does not overexpress HER2. This study compares two neoadjuvant therapy options to shrink tumors before surgery, aiming to improve operability and support breast-conserving surgery. The trial is a multicenter, open-label, randomized Phase 2 study involving 520 patients. Participants will receive one of two treatment combinations nab-paclitaxel with carboplatin, or nab-paclitaxel with epirubicin. Both regimens are given intravenously every 21 days for six cycles, with specific dosing schedules on days 1 and 8 for nab-paclitaxel and day 1 for the other drugs. The study compares the effects and safety of these two approaches in the neoadjuvant setting. During the study, patients will be closely monitored through blood tests, tumor tissue samples, and imaging to measure tumor response, including pathological complete response after three years. Researchers will also track objective response rates, disease-free survival, and adverse events over three years. The study includes assessments of heart and bone marrow function and requires participants to adhere to treatment plans and follow-up schedules for comprehensive evaluation.

Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Epirubicin in the Neoadjuvant Therapy for Breast Cancer