RecruitingPhase 3NCT04646759

Fulvestrant or Capecitabine Combined With Pyrotinib in HR+/HER2+ Metastatic Breast Cancer

Fulvestrant or Capecitabine Combined With Pyrotinib in HR-positive and HER2-Positive Metastatic Breast Cancer: A Multicenter, Randomized, Phase III Study


Sponsor

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

Enrollment

516 participants

Start Date

Oct 14, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

Capecitabine combined with pyrotinib is the standard protocol for HR+/HER2+ advanced breast cancer after trastuzumab failure, but the incidence of grade 3 hand-foot-syndrome was 16.4%. Therefore, the search for efficient and low toxicity alternatives has become a research hotspot. Our previous basic studies have shown that ER inhibitor fulvestrant and HER2 inhibitor pyrotinib have a synergistic effect. The preliminary analysis of our prospective shows that the efficacy is close to that of capecitabine combined with pyrotinib, and the adverse events are significantly improved compared with capecitabine combined with pyrotinib. Therefore, it is necessary to further carry out a head-to-head phase III randomized controlled clinical trial to study the efficacy and safety of fulvestrant combined with pyrotinib in the treatment of HR + / HER2 + advanced breast cancer.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial tests combinations of targeted drugs (pyrotinib with either fulvestrant or capecitabine) in women with a specific type of metastatic breast cancer that is both hormone receptor-positive (HR+) and HER2-positive. **You may be eligible if...** - You are a woman aged 18–80 with metastatic breast cancer confirmed as HR+ and HER2+ - You are postmenopausal (or have had ovarian suppression if premenopausal) - You have received prior trastuzumab-based treatment - You have at least one measurable tumor - Your general health score (WHO performance status) is 0–2 - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - You are male - You have not had prior trastuzumab treatment, or you have had more than one line of trastuzumab-based therapy for metastatic disease - Your cancer has not been confirmed as HR+ and HER2+ - Your health status is too poor to tolerate treatment 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

DRUGFulvestrant combined with Pyrotinib

Fulvestrant 500mg was injected intramuscularly on D1, D15, D28 and D28 Pyrotinib 400mg daily

DRUGCapecitabine combined with Pyrotinib

Capecitabine 1000mg/m\^2 bid d1-d14,every 21 days Pyrotinib 400mg daily


Locations(1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

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NCT04646759


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