Phase III Study Comparing the Order of Anthracycline and Taxane Chemotherapy in Women with Locally Advanced HER2-negative Breast Cancer

What this Trial Is About

Researchers are evaluating the best sequence of chemotherapy drugs for treating locally advanced HER2-negative breast cancer. This phase III, open-label, randomized trial includes 494 female patients with invasive breast carcinoma stages IIB to III. The study compares starting treatment with either anthracyclines plus cyclophosphamide or taxanes, with or without carboplatin for triple-negative subtypes, to determine which sequence is more effective. Participants are randomly assigned to one of two treatment groups. One group receives doxorubicin and cyclophosphamide intravenously every 21 days for three cycles, followed by docetaxel every 21 days for four cycles or weekly paclitaxel for 12 weeks. The other group starts with docetaxel or paclitaxel followed by doxorubicin and cyclophosphamide on the same schedule. Other treatments like surgery, radiotherapy, and hormone therapy are given according to usual care and are not part of the study. Throughout the study, participants undergo regular assessments including cardiac function tests such as echocardiogram or MUGA before treatment starts. The main outcome measured is invasive disease-free survival over an average of eight years. The trial monitors patient health and treatment response but does not alter standard post-chemotherapy care. Participation involves signing informed consent and agreeing to use contraception during and after treatment as required.

Evaluation of Sequencing of Anthracyclines and Taxanes for Locally Advanced HER2-negative Breast Cancer