An Open, Phase II Trial Assessing the Objective Response Rate After Combination of Arimidex® 1mg Per os/Day and Zoladex® 3.6 mg Sub Cut/Monthly as 1st Treatment for Premenopausal Receptor Positive Advanced or Metastatic Breast Cancer
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer
Female
Breast Cancer
Trial Information
An Open, Phase II Trial Assessing the Objective Response Rate After Combination of Arimidex® 1mg Per os/Day and Zoladex® 3.6 mg Sub Cut/Monthly as 1st Treatment for Premenopausal Receptor Positive Advanced or Metastatic Breast Cancer
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Determine the feasibility and efficacy of the combination of these 2 drugs in these patients
Principal Investigator
AstraZeneca France Medical Director, MD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
D5390L00061 Roche Study
NCT ID:
NCT00235937
Start Date:
December 2001
Completion Date:
December 2006
Related Keywords:
- Breast Cancer
- Premenopausal
- Advanced Breast Cancer
- Metastatic Breast Cancer
- Breast Neoplasms
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