RecruitingPhase 2NCT06125834

Trastuzumab Emtansine (T-DM1) in HER2-positive Breast Cancer Patients With Progressive Disease After TKIs or HP Therapy

Trastuzumab Emtansine (T-DM1) Treatment in HER2-positive Breast Cancer Patients With Progressive Disease After TKIs or HP Therapy: a Multicenter, Single-arm, Phase II Study


Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

36 participants

Start Date

Jun 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn about the efficacy and safety of trastuzumab emtansine (T-DM1) in the treatment of patients with advanced HER2-positive breast cancer after TKIs or HP therapy. The main questions it aims to answer are: * The objective response rate of patients receiving T-DM1 therapy with advanced HER2-positive breast cancer after TKIs or HP therapy. * The adverse events and prognosis of patients with advanced HER2-positive breast cancer who receive the T-DM1 therapy. * Changes of anti-tumor immunity during T-DM1 therapy in patients with advanced HER2-positive breast cancer. Participants will receive T-DM1 treatment (3.6mg/kg, d1/21, IVD) until progressive diseases or intolerable adverse effects occurs.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying the drug T-DM1 (trastuzumab emtansine, a targeted therapy) in women with HER2-positive breast cancer whose disease got worse after receiving other targeted treatments such as tyrosine kinase inhibitors (TKIs) or a combination of trastuzumab and pertuzumab (HP therapy). **You may be eligible if:** - You are a woman aged 18 or older with HER2-positive invasive breast cancer - Your cancer progressed after anti-HER2 targeted therapy (TKIs or HP) either for stage IV disease or within one year of completing adjuvant treatment - You have at least one measurable lesion - Your blood counts, liver, and kidney function are within acceptable ranges - Your heart function is normal (LVEF at least 55%) **You may NOT be eligible if:** - You are male or have inflammatory breast cancer - You have had another cancer in the past 5 years (except certain skin or cervical in-situ cancers) - You are currently on another cancer treatment or clinical trial - You have previously used ADC (antibody-drug conjugate) drugs - You have heart disease above NYHA class 2 - You have dementia, cognitive problems, or a mental illness that prevents giving informed consent 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

DRUGTrastuzumab Emtansine (T-DM1)

Enrolled patients will receive Trastuzumab Emtansine (T-DM1) treatment (3.6mg/kg, d1/21, IVD) until progressive diseases or intolerable adverse effects occurs.


Locations(1)

JiangSu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

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NCT06125834


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