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

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 cape

Trial Details

NCT ID
NCT04646759
Phase
PHASE3
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • Fulvestrant combined with Pyrotinib
  • Capecitabine combined with Pyrotinib
Locations (sample)
  • Guangzhou, Guangdong, China|23.11667,113.25

Key Eligibility Criteria

  • Adult female patients (aged 18-80 years, including 18 and 80 years) with metastatic breast cancer confirmed by pathology or imaging are not suitabl…
  • Pathological examination confirmed that ER and / or PR were positive, and HER-2 was positive (ER expression: immunohistochemical staining of tumor …
  • Postmenopausal patients (for premenopausal patients, ofs includes bilateral ovariectomy and GnRHa drugs);
  • The disease-free interval between the end of the last trastuzumab and tumor progression was more than 12 months;

For full eligibility, visit ClinicalTrials.gov.

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