An Open, Multicentre Phase I Clinical Study to Assess the Tolerability of Fulvestrant 500 mg in Postmenopausal Women With Hormone Receptor Positive Advanced or Recurrent Breast Cancer
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Female
Advanced Breast Cancer
Female
Advanced Breast Cancer
Trial Information
An Open, Multicentre Phase I Clinical Study to Assess the Tolerability of Fulvestrant 500 mg in Postmenopausal Women With Hormone Receptor Positive Advanced or Recurrent Breast Cancer
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
The primary objective of this study is to assess the tolerability of 500mg fulvestrant
Outcome Time Frame:
assessed when all patients have been in the study for 6 months
Safety Issue:
Yes
Principal Investigator
Breast Cancer Established Brands Team Medical Science Director, MD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
D6995C00004
NCT ID:
NCT00328120
Start Date:
April 2004
Completion Date:
June 2010
Related Keywords:
- Advanced Breast Cancer
- Advanced breast cancer
- Faslodex
- Breast Neoplasms
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