drugset / Trial / NCT04936295
Fulvestrant Plus Anlotinib in HR(+)/HER2(-) Metastatic Breast Cancer With FGFR Mutation
NaSingle-groupOpen-labelTreatment
Summary
Previous studies have shown that the FGF signaling pathway is closely related to endocrine therapy resistance in breast cancer, but there is not sufficient evidence for the combination of endocrine therapy and FGFR inhibitors. Anlotinib is a highly effective VEGFRs, FGFRs, PDGFRs multi-target tyrosine kinase inhibitor. Therefore, we conducted this single-arm, single-center phase II clinical study to evaluate the efficacy and the safety of anlotinib combined with fulvestrant in patients with metastatic HR+/HER2- breast cancer patients with FGFR mutation and resistance to aromatase inhibitor therapy, to provide new treatment options for these patients.
Timeline
- Start
- 2021-06-16
- Primary completion
- 2023-06-01
- Completion
- 2025-06-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Catequentinib | Small molecule | 20 mg | Oral |
| Subject | Fulvestrant | Small molecule | 500 mg | Intramuscular |