NCT06992882View on ClinicalTrials.gov

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)

PHASE3RecruitingINTERVENTIONAL

Enrollment

2,306

Participants

Timeline

Start Date

July 8, 2025

Primary Completion Date

June 8, 2028

Study Completion Date

June 10, 2030

Conditions

HER2-positive Breast Cancer

Interventions

DRUG

Capecitabine

capecitabine (1000-1250mg/m2, orally, bid, D1-14, q3w) and trastuzumab (first dose 8mg/kg, q3w; Follow-up maintenance 6 mg/kg, q3w, subcutaneous or intravenous for 1 year)

DRUG

Paclitaxel

paclitaxel (80mg/m2, qw, D1, 8, 15, intravenous, q3w) trastuzumab (first dose 8mg/kg, q3w; Follow-up maintenance 6mg/kg, q3w, subcutaneous or intravenous for 1 year)

Trial Locations (1)

200032

RECRUITING

Fudan University Shanghai Cancer Center Shanghai, China, 200032, Shanghai

All Listed Sponsors

lead

Fudan University

OTHER