Study on Pre-menopausal Patients With Advanced ER and PR + BC Treated With Arimidex Plus Zoladex

AstraZeneca

Status and phase

Completed

Phase 2

Conditions

Breast Cancer

Treatments

Drug: Anastrozole and goserelin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00235937

THR 0104233 C

D5390L00061 Roche Study

Details and patient eligibility

About

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.

Enrollment

45 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.