Pyrotinib in Combination With Fulvestrant in Patients With HER2 Positive,HR-Positive Metastatic Breast Cancer
Status:
Recruiting
Trial end date:
2022-07-06
Target enrollment:
Participant gender:
Summary
HR+/HER2+(Human epidermal growth factor receptor 2 positive and hormone receptor
positive)metastatic breast cancer is a special subtype of HER2+breast cancer. Conventional
guidelines recommend chemotherapy combined with trastuzumab targeted therapy for this subtype
of patients. However, the choice of treatment for these patients after treatment progress is
a research hotspot in this field. Pyrotinib is a new class I small molecule Tyrosine kinase
inhibitors(TKI) drug with high efficacy and low toxicity after the progress of trastuzumab
therapy. Fulvestrant is the most preferred single-drug therapy for HR + metastatic breast
cancer recommended unanimously by the guidelines, and fulvestrant and small molecule TKI have
synergistic effects. Therefore, we envisage that fulvestrant combined with Pyrotinib in the
treatment of HR+/HER2+ metastatic breast cancer in clinical practice has the advantages of
improving efficacy and survival. To this end, we intend to conduct a prospective,
multi-center, phase II clinical trial to evaluate the efficacy and safety of erlotinib in
combination with fulvestrant in patients with human epidermal growth factor receptor 2 (HER2)
positive,hormone receptor-positive metastatic breast cancer.
Phase:
Phase 2
Details
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University