RecruitingPhase 2NCT06178159

DV in Combination With Pertuzumab With or Without Toripalimab Neoadjuvant Therapy With HER2-positive Breast Cancer

A Phase II, Multicenter, Open-Label Neoadjuvant Study to Evaluate the Safety and Efficacy of Disitamab Vedotin in Combination With Pertuzumab With or Without Toripalimab for HER2 Positive Breast Cancer


Sponsor

RemeGen Co., Ltd.

Enrollment

40 participants

Start Date

Nov 28, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin in combination with Pertuzumab with or without Toripalimab neoadjuvant therapy in patients with HER2-positive breast cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a neoadjuvant (pre-surgery) treatment combination for HER2-positive breast cancer: an antibody-drug conjugate (DV — disitamab vedotin) combined with pertuzumab, with or without a third immunotherapy drug (toripalimab), to see if this achieves better tumor shrinkage before surgery compared to standard approaches. **You may be eligible if...** - You are 18 or older with HER2-positive invasive breast cancer - Your tumor is 2 cm or larger (clinical T2-T3) and has not spread to distant organs - You have not received any prior anti-cancer treatment for your breast cancer - Your heart function is normal (ejection fraction 55% or higher) - You are willing and able to undergo breast cancer surgery after treatment **You may NOT be eligible if...** - Your breast cancer is HER2-negative - Your tumor has spread to distant organs (stage IV) - You have received any prior treatment for breast cancer - You have significant heart disease or poor cardiac function - 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 Injection

2.0mg/kg, intravenous infusion,D1, every 2 weeks, Every 6 weeks is a treatment cycle. A total of 3 cycles (18 weeks) of treatment are performed.

DRUGPertuzumab Injection

Initial dose 840mg, after 2nd dose 420mg intravenous infusion, every 3 weeks

DRUGToripalimab

3.0 mg/kg, intravenous infusion, D1, every 2 weeks


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

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NCT06178159


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