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RecruitingPhase 2NCT06389006

To Evaluate the Efficacy and Safety of Disitamab Vedotin Combined With Toripalimab Sequential Chemotherapy as Neoadjuvant Treatment in Patients With HR-positive, HER2-low Breast Cancer

A Single-arm, Open-label, Multicenter Phase II Clinical Trial to Evaluate the Efficacy and Safety of Disitamab Vedotin Combined With Toripalimab Sequential Chemotherapy as Neoadjuvant Treatment in Patients With HR-positive, HER2-low Breast Cancer

Sponsor

RemeGen Co., Ltd.

Enrollment

79 participants

Start Date

Apr 29, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

Summary

The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin combined with Toripalimab sequential chemotherapy as in patients with HR-positive, HER2-low breast cancer

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two drugs — disitamab vedotin (an antibody-drug that targets HER2) and toripalimab (an immune checkpoint drug) — given before surgery in women with hormone receptor-positive, HER2-low breast cancer (cancer that has a small amount of the HER2 protein but not enough to qualify for standard HER2-targeted treatment). **You may be eligible if...** - You are 18 or older - You have confirmed invasive breast cancer at clinical stage T1c-T3 with lymph node involvement (cN1-2) or large tumor (T3) with or without node involvement - Your tumor is HER2-low (IHC 1+ or IHC 2+ without amplification) and hormone receptor-positive (ER or PR ≥ 1%) - You have not received any prior breast cancer treatment - Your heart pumping function (ejection fraction) is at least 50% **You may NOT be eligible if...** - You have received prior systemic treatment for breast cancer - You have active heart failure (NYHA Grade 3 or 4) - You have serious liver, kidney, or blood count problems - You are pregnant or breastfeeding 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

DRUGDisitamab Vedotin for Injection

2.0mg/kg, intravenous infusion，D1, every 2 weeks, Every 6 weeks is a treatment cycle. A total of 2 cycles (12 weeks) of treatment are performed

DRUGToripalimab

3.0 mg/kg, intravenous infusion, D1, every 2 weeks, every 6 weeks is a treatment cycle. A total of 2 cycles (12 weeks) of treatment are performed. Sequential therapy 3.0 mg/kg, intravenous infusion, D1, every 2 weeks,every 6 weeks is a treatment cycle. A total of 2 cycles (12 weeks) of treatment are performed.

DRUGEpirubicin

According to body surface area, 90mg/m2, intravenous infusion, D1, every 3 weeks, Every 6 weeks is a treatment cycle. A total of 12 weeks of treatment are performed.

DRUGCyclophosphamide

According to body surface area,600mg/m2, intravenous infusion, D1, every 3 weeks , Every 6 weeks is a treatment cycle. A total of 12 weeks of treatment are performed

Locations(1)

Jiong Wu

Shanghai, Fudan University Shanghai Cancer Center, China

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NCT06389006

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