drugset / Trial / NCT04936295

Fulvestrant Plus Anlotinib in HR(+)/HER2(-) Metastatic Breast Cancer With FGFR Mutation

NCT04936295 ↗

Phase 2 Unknown 61 enrolled Sun Yat-sen University
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

EvaluationDrugModalityDoseRoute
Subject Catequentinib Small molecule 20 mg Oral
Subject Fulvestrant Small molecule 500 mg Intramuscular

Indications