Phase III Study Comparing Oral Capecitabine Plus Trastuzumab Versus Paclitaxel Plus Trastuzumab in Adjuvant Treatment of HER2-positive, Lymph Node-negative Early Breast Cancer

What this Trial Is About

Researchers are studying HER2-positive, lymph node-negative early breast cancer in females to find the best adjuvant treatment strategy while reducing side effects. This phase III, randomized, open-label trial compares two treatments in patients with stage IA breast cancer, where tumors measure up to 2 cm and lymph nodes are negative. The study aims to evaluate the effectiveness and safety of combining paclitaxel plus trastuzumab with or without capecitabine in this setting. Participants are randomly assigned to one of two treatment groups. One group receives oral capecitabine plus trastuzumab, with capecitabine given twice daily for 14 days every 3 weeks and trastuzumab administered initially at 8 mg/kg every 3 weeks, followed by maintenance doses of 6 mg/kg subcutaneously or intravenously for one year. The second group receives paclitaxel intravenously at 80 mg/m2 weekly on days 1, 8, and 15 every 3 weeks, alongside the same trastuzumab dosing schedule. Treatment lasts for one year with close monitoring. Throughout the study, participants undergo evaluations to assess invasive disease-free survival at 5 years as the primary outcome, plus distant disease-free survival and overall survival as secondary outcomes. Organ function tests, cardiac monitoring including ECG and left ventricular ejection fraction, and laboratory blood tests ensure safety. Follow-up lasts up to 5 years post-treatment to observe long-term effects. Participants provide informed consent and are expected to comply with follow-up visits and procedures.

A Randomized, Open-label, Multi-center Phase III Study Comparing the Efficacy of Oral Chemotherapy Combined With Trastuzumab Versus Paclitaxel Combined With Trastuzumab in the Adjuvant Treatment of HER2-positive, Lymph Node-negative Early Breast Cancer Patients(ORCHID-PLUS)