RecruitingPhase 4NCT06641544

The Efficacy and Safety of Different Combination Regimens of Inetetamab in First-line Treatment of HER2 Positive Metastatic Breast Cancer


Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Enrollment

200 participants

Start Date

Oct 17, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study is to explore the efficacy and safety of the first-line treatment of HER2 positive recurrent/metastatic breast cancer with Inetetamab combined with Pertuzumab or Pyrotinib combined with chemotherapy, hoping to have better clinical benefits and provide a new treatment mode for targeted treatment.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing different drug combinations involving inetetamab (an anti-HER2 antibody) as a first-line treatment for women with HER2-positive breast cancer that has spread or come back. **You may be eligible if...** - You are a woman between 18 and 70 years old - Your breast cancer has been confirmed as HER2-positive by lab testing - Your cancer has come back locally or spread to other organs - You have not previously received first-line anti-HER2 treatment, or completed prior HER2 treatment more than 12 months ago - Your general health is good enough to tolerate treatment (ECOG 0-2) - Your heart function is adequate (LVEF at least 50%) **You may NOT be eligible if...** - Your cancer has spread to the brain and is symptomatic - You have significant heart problems - You have active hepatitis B or C, or HIV - You are pregnant or breastfeeding - You have had a major surgery within the past 4 weeks 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

DRUGInetetamab

Group A received Inetetamab+Pertuzumab+TPC, while Group B received Inetetamab+Pyrotinib+TPC.


Locations(1)

Sun Yat sen Memorial Hospital of Sun Yat sen University Shenzhen Shantou Central Hospital

Shanwei, Guangdong, China

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NCT06641544


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