RecruitingNCT06754059

Pyrotinib Combined With Trastuzumab for Maintenance Therapy After First-line TH (P) Therapy for HER2+ABC

A Single-arm, Multicenter, Real-world Observational Study of Pyrotinib Combined With Trastuzumab for Maintenance Therapy After First-line TH (P) Therapy for HER2+ABC


Sponsor

zhangjie

Enrollment

60 participants

Start Date

Jun 1, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

A single-arm, multicenter, real-world observational study of pyrotinib combined with trastuzumab for maintenance therapy after first-line TH (P) therapy for HER2+ABC


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether combining pyrotinib (a targeted HER2-blocking drug taken as a pill) with trastuzumab (a HER2-targeting antibody) as maintenance therapy can prevent or delay cancer recurrence in women with HER2-positive metastatic breast cancer who responded to prior treatment. **You may be eligible if...** - You are female, aged 18–70 - You have HER2-positive invasive breast cancer that has spread (recurrent or metastatic) - You had a recurrence more than 1 year after trastuzumab treatment, or you were newly diagnosed with stage IV disease - You are in good health (ECOG 0–1) with expected survival of at least 6 months - Your blood counts, liver, kidney, and heart function are within required ranges **You may NOT be eligible if...** - You have brain metastases (cancer spread to the brain) - You have had gastrointestinal surgery or have difficulty swallowing pills - You are pregnant or breastfeeding - You have a known allergy to the study drugs - You have severe mental illness 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

DRUGPyrotinib

In this study, after at least 4 cycles of taxoid chemotherapy combined with trastuzumab ± pertuzumab, the evaluation result reached SD, CR or PR, and capecitabine combined with pyrotinib + trastuzumab was given successively in the later period (capecitabine was used for 4-6 cycles


Locations(1)

Fujian Union Medical College Hospital

Fuzhou, Fujian, China

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NCT06754059


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