500mg Fulvestrant in HR+ MBC

Completed

• Conditions: Breast Cancer

• Registration Number: NCT03708432
• Lead Sponsor: Fudan University

Brief Summary

To study the real world use of 500mg Fulvestrant in HR+ MBC.

Detailed Description

An observational, retrospective study of 500mg Fulvestrant in hormone receptor+/HER2- advanced breast cancer

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-07-15
• Primary Completion: 2018-06-15
• Study Completion: 2018-08-15
• Study First Submitted: 2018-10-13
• Study First Submitted QC: 2018-10-13
• Study First Posted: 2018-10-17
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-23
• Last Update Posted: 2024-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

1. Diagnosed with ER/PR+，HER2- advanced breast cancer
2. Advanced breast cancer included unresectable locally advanced breast cancer, de novo stage IV breast cancer, and recurrent metastatic breast cancer.

3.500mg Fulvestrant treatment of advanced breast cancer for at least one month, between Jan 2011 and Dec 2015.

4.Available medical history

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Exclusion Criteria

1. Incomplete medical history
2. HER2 overexpression or gene amplification, ie, immunohistochemistry (IHC) 3+ or fluorescence in situ hybridisation (FISH)+, where appropriate.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PFS	6 weeks	Progression free survival

Secondary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	6 weeks

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China