RecruitingNCT06548919

Current Status of Treatment for Chinese Patients With ESR1-mutated HR+/HER2-advanced Breast Cancer

Effectiveness and Safety of Different Treatment Regimens in Patients With ESR1-mutated HR+/HER2-advanced Breast Cancer After Failure of Prior Endocrine Therapy: a Prospective, Non-interventional, Real-world Study

Sponsor

SciClone Pharmaceuticals

Enrollment

450 participants

Start Date

Aug 8, 2024

Study Type

OBSERVATIONAL

Conditions

Advanced Breast Cancer ESR1 Gene Mutation

Summary

This is a prospective, non-interventional real-world study to observe the efficacy and safety of different treatment regimens in patients with ESR1-mutated HR+/HER2-advanced breast cancer after failure of endocrine therapy. Epidemiological data, efficacy and safety measures will be collected for each subject. Data on efficacy and safety assessment indicators will be collected every 2-3 months until disease progression, receipt of a new anti-tumour treatment modality, death, loss to follow-up, and arrival at the data collection cut-off date. The cut-off date for data collection is defined as 8 weeks after completion of 6 visits for each subject, or 4 weeks after treatment discontinuation and subject discontinuation/withdrawal. Subjects receiving a different treatment regimen remained subject to assessment of safety indicators 4 weeks after discontinuation of the original treatment regimen.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This observational study is collecting real-world data on Chinese women with advanced breast cancer that is hormone receptor-positive (HR+), HER2-negative, and has a specific genetic mutation called ESR1. This mutation makes certain hormone-blocking treatments less effective. The study aims to understand how these patients are being treated in practice and what outcomes they experience. **You may be eligible if...** - You are a woman aged 18 or older - You have been diagnosed with advanced or metastatic breast cancer that is ER-positive, HER2-negative, and has an ESR1 mutation - You are postmenopausal (either naturally, after ovary removal, or via ovarian suppression therapy) - You have received at least one prior endocrine (hormone-blocking) therapy **You may NOT be eligible if...** - Your cancer does not have the ESR1 mutation - You are premenopausal without ovarian suppression therapy - You have not yet started any endocrine therapy - Your cancer is HER2-positive 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

DRUGEndocrine therapy

All endocrine treatment regimens approved for advanced breast cancer, including tamoxifen, aromatase inhibitors, fulvestrant, etc.

DRUGChemotherapy Prednisone

All chemotherapy treatment regimens approved for advanced breast cancer

Locations(1)

Tianjin Haidafu Internet Hospital

Suzhou, Jiangsu, China

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NCT06548919

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