Fulvestrant or Capecitabine Combined With Pyrotinib in HR+/HER2+ Metastatic Breast Cancer
Status:
Recruiting
Trial end date:
2030-12-14
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University