Study on Pre-menopausal Patients With Advanced ER and PR + BC Treated With Arimidex Plus Zoladex
Phase 2
Completed
- Conditions
- Breast Cancer
- Registration Number
- NCT00235937
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is to determine the efficacy and tolerance of the association of two drugs already marketed and used to treat your disease: Arimidex® 1 Mg per day per os and Zoladex® 3,6 Mg in injections under cutaneous once per month in subjects with breast cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 45
Inclusion Criteria
- Signed informed consent, premenopausal women 18 years or older, histologically or cytologically confirmed locally advanced or metastatic breast cancer, suitable for endocrine treatment, no curative treatment available,, one or more measurable lesions, life expectancy more than 6 months, normal biological parameters.
Exclusion Criteria
- Presence of life-threatening metastases, previous endocrine therapy or chemotherapy for advanced or metastatic disease, any previous treatment with hormone (LH-RH) severe or uncontrolled systemic disease, pituitary adenoma, High risk of medullar compression.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Determine the feasibility and efficacy of the combination of these 2 drugs in these patients
- Secondary Outcome Measures
Name Time Method To assess clinical benefit rate, time to progression, duartion of response and safety in patients treated with the combination of these 2 drugs