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)

Although there is a certain risk of recurrence of HER2-positive small tumors, the overall prognosis is relatively good. In order to further reduce the toxicity and side effects of treatment and explore the best strategy for adjuvant therapy in patients with HER2-positive stage IA breast cancer, we designed this phase III, randomized, open-label study to evaluate the efficacy and safety of paclitaxel plus trastuzumab and capecitabine versus paclitaxel plus trastuzumab in the adjuvant treatment of patients with HER2-positive, node-negative breast cancer.

NCT Number	NCT06992882
Lead Sponsor	Fudan University
Conditions	HER2-positive Breast Cancer
Enrollment	2,306 participants
Start Date	2025-07-08
Primary Completion	2028-06-08 (estimated)
Study Completion	2030-06-10 (estimated)
Updated on ClinicalTrials.gov	2025-07-18