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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)

StatusRecruiting
PhasePhase 3
Started2025-07-08
View on ClinicalTrials.gov ↗

Amendment history

2025-07-15
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2025-06-10→2028-06-08
Start dateestimated 2025-06-01→confirmed 2025-07-08
Study sites0→1
2025-05-20
minor
Original filing
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.
Trial Details
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