Comparing Albumin-bound Paclitaxel with Carboplatin to Epirubicin with Docetaxel as Pre-Surgery Treatment for Triple-Negative Breast Cancer

What this Trial Is About

Researchers are investigating the effectiveness of albumin-bound paclitaxel combined with carboplatin compared to epirubicin combined with docetaxel as pre-surgery neoadjuvant treatment for triple-negative breast cancer. This type of breast cancer lacks certain hormone receptors, tends to be more aggressive, and has fewer treatment options, making chemotherapy the main approach. The study is a phase IV multicenter randomized controlled trial aiming to improve treatment outcomes for this challenging cancer type. Participants receive one of two chemotherapy regimens before surgery. In the trial group, albumin-bound paclitaxel is given intravenously at 125 mgm2 on days 1 and 8 of a 21-day cycle for six cycles, along with carboplatin administered intravenously on the same days. Carboplatin requires hydration for three days before use to protect the kidneys. The control group receives epirubicin intravenously at 90 mgm2 and docetaxel at 75 mgm2 every 21 days for four cycles. During the study, participants undergo assessments including tumor measurements and evaluations of their overall health and organ function. Researchers monitor pathologic complete remission rates five years after treatment, along with breast-conserving surgery rates, bone health, distant metastasis, disease-free survival, overall survival, and adverse events over five years. The trial includes safety monitoring and long-term follow-up to evaluate the treatments impact on patient outcomes.

Albumin-bound Paclitaxel and Carboplatin Versus Epirubicin and Docetaxel for Triple-negative Breast Cancer