RecruitingPhase 3NCT06992882

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)


Sponsor

Fudan University

Enrollment

2,306 participants

Start Date

Jul 8, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two chemotherapy-plus-targeted-therapy treatment plans for women with early-stage, HER2-positive breast cancer that has not spread to the lymph nodes. You may be eligible if... - You are a woman between 18 and 70 years old - You have early-stage HER2-positive breast cancer (the tumor is no larger than 2 cm and has not spread to lymph nodes) - Your surgery was completed within the past 8 weeks - Your heart, blood, liver, and kidney function are within acceptable ranges You may NOT be eligible if... - You received chemotherapy, targeted therapy, radiation, or hormone treatment before surgery - You have cancer that has spread to other parts of the body - You are pregnant or breastfeeding - You have serious heart, lung, liver, or kidney problems - You have uncontrolled high blood pressure or poorly managed diabetes Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCapecitabine

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)

DRUGPaclitaxel

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)


Locations(1)

Fudan University Shanghai Cancer Center Shanghai, China, 200032

Shanghai, Shanghai Municipality, China

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NCT06992882


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