RecruitingPhase 4NCT06217185

The Efficacy and Safety of Pyrotinib, Trastuzumab Combined With Taxanes in the Treatment of Trastuzumab-treated HER2+ Advanced Breast Cancer (ABC).

The Efficacy and Safety of Pyrotinib, Trastuzumab Combined With Taxanes in the Treatment of Early Trastuzumab-treated HER2+ Advanced Breast Cancer (ABC).


Sponsor

Hebei Medical University Fourth Hospital

Enrollment

100 participants

Start Date

Jan 2, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multi-center real-world study, in which patients who meet the inclusion criteria will receive treatment with Pyrotinib + Trastuzumab + Taxanes. Taxanes will be used for 6-8 cycles or discontinued due to intolerable Adverse Events (AEs), after which Capecitabine will be used for rhythmic chemotherapy combined with Pyrotinib + Trastuzumab. The aim is to explore the efficacy and safety of Pyrotinib, Trastuzumab, and Taxanes in treating Trastuzumab-treated HER2+ Advanced Breast Cancer (ABC).


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying a combination of three drugs — pyrotinib, trastuzumab (Herceptin), and taxane chemotherapy — in women with HER2-positive advanced or metastatic breast cancer who have already been treated with trastuzumab and whose cancer has come back. **You may be eligible if...** - You are a woman aged 18–70 - Your breast cancer has been confirmed as HER2-positive (a specific protein that drives cancer growth) - Your cancer has returned or spread after prior trastuzumab-based treatment - You have not had more than 2 previous drug treatment regimens for advanced disease - You have at least one measurable tumor site and are in good enough health to receive treatment **You may NOT be eligible if...** - You have had more than 2 prior chemotherapy regimens for advanced breast cancer - You have known brain metastases that are symptomatic or unstable - You have serious heart problems or a heart function below a safe threshold - You are pregnant or breastfeeding - You have already been treated with pyrotinib or similar drugs 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

Pyrotinib 400mg qd po continuously

DRUGTrastuzumab

For Trastuzumab, the loading dose for the first treatment cycle is 8 mg/kg, and for subsequent cycles, 6 mg/kg. It is to be used once every three weeks

DRUGTaxanes

Taxanes: Usual clinical dose is administered, in a 21-day cycle.

DRUGCapecitabine

Capecitabine: 650mg/m2 each time, given twice daily


Locations(1)

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

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NCT06217185


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