Fulvestrant 500mg in Patients With Advanced Breast Cancer

• Conditions: Metastatic Breast Cancer
• Interventions: Drug: Fulvestrant

• Registration Number: NCT02909361
• Lead Sponsor: Fudan University

Brief Summary

Fulvestrant 500mg in Patients With Advanced Breast Cancer

Detailed Description

A multicenter, prospective study real-world to evaluate the safety profile and effectiveness in Chinese patients who received Fulvestrant 500mg as first-line endocrine treatment for Advanced breast cancer

Study Timeline

• Study First Submitted: 2016-09-12
• Study First Submitted QC: 2016-09-18
• Study First Posted: 2016-09-21
• Study Start: 2017-10-11
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-20
• Primary Completion: 2022-06
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 500

Inclusion Criteria

1. Chinese women with estrogen receptor positive, locally advanced or metastatic breast cancer who has already received Fulvestant 500mg treatment as determined by treating physician. Ovarian suppression in premenopausal women is permitted, including ovarian ablation and LHRHa.
2. Histologically confirmed positive oestrogen receptor status (ER positive) of primary breast cancer or metastatic tumour tissue, according to the local laboratory parameters.
3. Prior endocrine therapy for advanced disease was not permitted.
4. The prescription of the Fulvestant is clearly separated from the decision to include the subject in the NIS, and is part of normal medical practice. The recruitment of the patient to the study should be within 1 month of the first Fulvestant injection.
5. Provision of subject informed consent.

Exclusion Criteria

1. If participating in any controlled clinical trial, the subject cannot take part in this study.
2. HER2 overexpression or gene amplification, ie, immunohistochemistry (IHC) 3+ or fluorescence in situ hybridisation (FISH)+, where appropriate.
3. Pervious regimen of endocrine therapy for advanced disease.
4. More than one regimen of chemotherapy for advanced disease.
5. Pregnancy and lactation.
6. Severe hepatic impairment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fulvestrant	Fulvestrant	500 mg on days 0, 14, and 28, and every 28 days thereafter

Primary Outcome Measures

Name	Time	Method
Incidence, nature and severity of all Adverse Events assessed by CTCAE V4.0	From date of randomization until the date of date of death from any cause or last visit, assessed up to 100 months.	Incidence, nature and severity of all Adverse Events assessed by CTCAE V4.0

Secondary Outcome Measures

Name	Time	Method
PFS	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.	Progression Free Survival
ORR	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.	Objective Response Rate
CBR	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.	Clinical Benefit Rate
OS	From date of randomization until the date of date of death from any cause or last visit, assessed up to 100 months.	Overall Survival

Trial Locations

Locations (1)

Fudan University Cancer Hospital; 🇨🇳 Shanghai, China