Study Comparing Nab-paclitaxel with Carboplatin Versus Nab-paclitaxel with Capecitabine for Advanced Triple-negative Breast Cancer in Women Aged 18 to 70

What this Trial Is About

Researchers are evaluating two combination chemotherapy treatments for advanced triple-negative breast cancer TNBC, a type of breast cancer lacking estrogen, progesterone, and HER2 receptors. TNBC often affects younger women and tends to be more aggressive. This phase 2 trial compares the safety and effectiveness of nab-paclitaxel combined with either carboplatin or capecitabine in patients who have had up to one prior systemic treatment for metastatic disease. Participants receive one of two treatment regimens nab-paclitaxel plus carboplatin or nab-paclitaxel plus capecitabine. Both treatments are given intravenously every 21 days for six cycles, with specific dosing schedules for each drug. After completing combination chemotherapy, patients continue maintenance therapy with oral capecitabine every 21 days until their disease progresses or side effects become intolerable. During the study, participants will be monitored regularly to assess treatment response and side effects. Researchers will measure outcomes such as progression-free survival over three years, response rates after six treatment cycles, overall survival, and adverse events. The study includes safety evaluations and follows patients for up to three years to gather comprehensive data on treatment effects and tolerability.

Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Capecitabine in the Treatment of Advanced Triple-negative Breast Cancer