Overview

Fulvestrant 500mg in Patients With Advanced Breast Cancer

Status:
Unknown status
Trial end date:
2020-10-01
Target enrollment:
0
Participant gender:
Female
Summary
Fulvestrant 500mg in Patients With Advanced Breast Cancer
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fudan University
Treatments:
Estradiol
Fulvestrant
Criteria
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.