RecruitingNCT06734533

Anlotinib-based Combination Therapy in Patients with Hormone Receptor-positive(HR+) Metastatic Breast Cancer(MBC) .

A New Option for Post-CDK4/6is Resistance Era: Multicenter Real-world Study of Anlotinib-based Combination Therapy in Hormone Receptor-positive Metastatic Breast Cancer Resistant to CDK4/6is.


Sponsor

Hunan Cancer Hospital

Enrollment

80 participants

Start Date

Dec 5, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

Cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitors combined with hormonal therapy are the current standard frontline treatment for patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER-2)-negative metastatic breast cancer (MBC). However, the optimal treatment after progression on CDK4/6 inhibitors remains unknown. Anlotinib is an oral multi-target tyrosine kinase inhibitor (TKI) that strongly inhibits VEGFR, PDGFR, FGFR, and c-kit. This study aimed to evaluate the safety and efficacy of anlotinib-based combination therapy in patients with HR+ MBC previously treated with a CDK4/6 inhibitor.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing combinations of medications that include anlotinib (a drug that cuts off blood supply to tumors) for women with hormone receptor-positive, HER2-negative breast cancer that has spread to other parts of the body and is no longer responding to standard treatments. **You may be eligible if...** - You are a woman between 18 and 75 years old - You have hormone receptor-positive (HR+), HER2-negative breast cancer that has spread (metastatic) - You have already tried multiple lines of treatment and have no remaining standard options - You have measurable disease that can be tracked by imaging - Your general health score (ECOG) is 0 or 1, and you are expected to survive at least 3 months **You may NOT be eligible if...** - You still have standard treatment options available - Your cancer is HER2-positive - You are in poor general health 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

OTHERAnlotinib+eribulin/nab-paclitaxel/etoposide/capecitabine/pembrolizumab/ sintilimab/ fulvestrant, etc

Anlotinib (8/10/12 mg daily, Day 1-14 of each cycle) was administered orally to fasting patients, with dose reductions to 10 mg or 8 mg in cases of intolerable toxicity. Combination agents included eribulin, nab-paclitaxel, etoposide, capecitabine, pembrolizumab, sintilimab, or fulvestrant, among others.


Locations(1)

Hunan Provincial Tumor Hospital

Changsha, Hunan, China

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NCT06734533


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