Fulvestrant 500mg in Patients With Advanced Breast Cancer

Metastatic Breast Cancer Clinical Trial

Official title:

A Multicenter, Prospective, Real-world Study to Evaluate the Safety Profile and Effectiveness in Chinese Patients Who Received Fulvestrant 500mg as First-line Endocrine Treatment for Advanced Breast Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02909361
• Other study ID #: Fudan BR2016-21
• Status: Active, not recruiting
• Start date: October 11, 2017
• Est. completion date: October 2022

Study information

• Verified date: April 2022
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Fulvestrant 500mg in Patients With Advanced Breast Cancer

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: October 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• Fulvestrant
500 mg on days 0, 14, and 28, and every 28 days thereafter

Locations

Country	Name	City	State
China	Fudan University Cancer Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence, nature and severity of all Adverse Events assessed by CTCAE V4.0	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.
Secondary	ORR	Objective Response Rate	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.
Secondary	CBR	Clinical Benefit Rate	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.
Secondary	PFS	Progression Free Survival	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.
Secondary	OS	Overall Survival	From date of randomization until the date of date of death from any cause or last visit, assessed up to 100 months.