500mg Fulvestrant Versus Everolimus Plus Exemestane in MBC Patients Refractory to Previous AI

Completed

• Conditions: Breast Cancer

• Registration Number: NCT03695341
• Lead Sponsor: Fudan University

Brief Summary

500mg Fulvestrant versus Everolimus plus Exemestane in MBC patients refractory to previous AI

Detailed Description

Fulvestrant versus Everolimus plus Exemestane for patients with Metastatic Breast Cancer resistant to Aromatase Inhibitors: the clinical experience from real -world

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-05-14
• Study First Submitted: 2018-10-02
• Study First Submitted QC: 2018-10-02
• Study First Posted: 2018-10-04
• Primary Completion: 2019-03-10
• Study Completion: 2019-05-15
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-16
• Last Update Posted: 2019-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 130

Inclusion Criteria

1. Patients diagnosed with ER/PR+，HER2- Metastatic Breast Cancer
2. Patients who were refractory to previous Aromatase Inhibitors
3. Patients treated with Fulvestrant or Everolimus plus Exemestane in any line in metastatic setting in Fudan University Shanghai Cancer Center，starting from 2013.06.01-2016.06.01
4. Available medical history

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Exclusion Criteria

1.Incomplete medical history

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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