Faslodex 500mg Multiple Dose Tolerability Study in BC Patients
Phase 1
Completed
- Conditions
- Advanced Breast Cancer
- Registration Number
- NCT00328120
- Lead Sponsor
- AstraZeneca
- Brief Summary
The primary objective of this study is to assess the tolerability of 500mg fulvestrant in postmenopausal women with hormone receptor positive, advanced or recurrent breast cancer
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 20
Inclusion Criteria
- Provision of written informed consent
- Postmenopausal woman who fulfils any one of the following criteria:
- Histological or cytological confirmation of breast cancer
- Estrogen receptor positive (ER+) or progesterone receptor positive (PgR+).
Exclusion Criteria
- Having received any one of the following therapy for advanced or recurrent breast cancer
- 2 or more regimens of hormonal therapy or immunotherapy or 2 or more regimens of chemotherapy, etc
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method The primary objective of this study is to assess the tolerability of 500mg fulvestrant assessed when all patients have been in the study for 6 months
- Secondary Outcome Measures
Name Time Method Pharmacokinetics each visit Time to progression assessed when all patients have been in the study for 6 months ORR assessed when all patients have been in the study for 6 months Clinical benefit rate assessed when all patients have been in the study for 6 months Time to response assessed when all patients have been in the study for 6 months duration of response and changes in serum tumour markers assessed when all patients have been in the study for 6 months
Trial Locations
- Locations (1)
Research Site
🇯🇵Tokyo, Japan