RecruitingPhase 2NCT05075512

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

A Prospective Study on Efficacy and Safety of Anlotinib Combined With Fulvestrant in Patients With HR-positive and HER2-negative, Secondary Endocrine-resistant, Locally Advanced or Metastatic Breast Cancer


Sponsor

Zhejiang Cancer Hospital

Enrollment

40 participants

Start Date

Sep 1, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying the combination of anlotinib (a drug that blocks tumor blood vessel growth) and fulvestrant (a hormone therapy) in women with hormone receptor-positive, HER2-negative advanced breast cancer. **You may be eligible if...** - You are a woman aged 18 or older - You have HR-positive, HER2-negative breast cancer that is advanced or metastatic - Your cancer relapsed within 12 months of at least 2 years of hormone therapy, or progressed after at least 6 months of hormone salvage therapy - You have not received more than one prior chemotherapy regimen for metastatic disease - You have at least one measurable tumor - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - You have previously received fulvestrant or anti-angiogenic drugs - Your cancer involves a life-threatening organ crisis (visceral crisis) - You have uncontrolled brain metastases - You are pregnant or breastfeeding - You have uncontrolled high blood pressure or significant clotting/bleeding problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGanlotinib, fulvestrant

anlotinib: 12 mg once daily on days 1-14, repeated every 21 days; fulvestrant: 500 mg on days 1 and 15 of cycle one, and then on day one of each subsequent 28 days cycle


Locations(1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

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NCT05075512


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