Fulvestrant 500mg in Patients With Advanced Breast Cancer

Fudan University

Status: Unknown

Conditions: Metastatic Breast Cancer

Treatments: Drug: Fulvestrant

Study type: Observational

Funder types: Other

Identifiers

NCT02909361

Fudan BR2016-21

Details and patient eligibility

About

Fulvestrant 500mg in Patients With Advanced Breast Cancer

Full 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

Enrollment: 500 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

500 participants in 1 patient group

Fulvestrant

Description:

500 mg on days 0, 14, and 28, and every 28 days thereafter

Treatment:

Drug: Fulvestrant