drugset / Trial / NCT05075512

The Efficacy and Safety of Anlotinib Combined With Fulvestrant in Patients With Advanced Breast Cancer

NCT05075512 ↗

Phase 2 Recruiting 40 enrolled Zhejiang Cancer Hospital
NaSingle-groupOpen-labelTreatment

Summary

The management of HR-positive, HER2-negative metastatic breast cancer includes endocrine monotherapy or combination regimens, both with benefit diminishing as resistance develops. Nowadays, various studies have demonstrated that estrogen interacts with many angiogenic pathways and is an important mechanism for resistance leading to the question of whether combination with antiangiogenesis and antiestrogen therapies could be an appropriate therapeutic modality. Anlotinib is a novel multi-target tyrosine kinase inhibitor that effectively inhibit VEGFR, FGFR, PDGFR, c-KIT, c-MET and RET. Previous studies have proven the efficacy of both anlotinib monotherapy and combination regimens in advanced breast cancer. This phase II study aims to preliminarily evaluate the efficacy and safety of anlotinib combined with endocrine therapy.

Timeline

Start
2021-09-01
Primary completion
2023-08-31
Completion
2026-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Catequentinib Small molecule 12 mg Oral
Subject Fulvestrant Small molecule 500 mg Intramuscular

Indications