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RECRUITING
NCT06734533

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

Sponsor: Hunan Cancer Hospital

View on ClinicalTrials.gov

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.

Official title: 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.

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

80

Start Date

2024-12-05

Completion Date

2025-12-30

Last Updated

2024-12-16

Healthy Volunteers

No

Interventions

OTHER

Anlotinib+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