Study of Anlotinib Combined With Fulvestrant for Women With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Resistant to Endocrine Therapy

What this Trial Is About

Researchers are investigating treatments for hormone receptor-positive, HER2-negative metastatic breast cancer that has become resistant to standard hormone therapy. This phase II clinical trial focuses on whether combining anlotinib, a new type of drug that blocks multiple pathways involved in tumor growth, with fulvestrant, an endocrine therapy, can improve outcomes for patients whose cancer has relapsed or progressed despite prior hormone treatments. Participants receive oral anlotinib daily for two weeks followed by a one-week break, repeated every 21 days, combined with intramuscular fulvestrant given on day 1 and 15 of the first cycle and then once every 28 days thereafter. Treatment continues until the disease worsens or side effects become intolerable. This single-arm study plans to enroll 40 patients to evaluate the effectiveness and safety of this combination therapy. During the trial, patients will be closely monitored through assessments including tumor measurements to evaluate progression-free survival over up to 60 months. Researchers will also track response rates, overall survival, and any side effects. Safety evaluations continue for 30 days after the last dose. The study aims to understand how well this combination may control the cancer and what side effects occur in this patient group.

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