Anastrozole and Fulvestrant Compared to Anastrozole as Adjuvant Treatment of Postmenopausal Patients With Breast Cancer
Purpose is to compare the frequency of events (presence of Disseminated Tumour Cells, clinical recurrence and/or death) after 1 and 2 years of adjuvant treatment with anastrozole and fulvestrant or anastrozole alone in patients with early breast cancer...
Brief Summary
Official Title: “A Randomised Phase II Study Comparing Anastrozole and Fulvestrant to Anastrozole for Adjuvant Treatment of Postmenopausal Patients With Early Breast Cancer and Disseminated Tumour Cells in Bone Marrow”
Purpose is to compare the frequency of events (presence of Disseminated Tumour Cells, clinical recurrence and/or death) after 1 and 2 years of adjuvant treatment with anastrozole and fulvestrant or anastrozole alone in patients with early breast cancer.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: October 2008
Intervention(s) in this Clinical Trial
- Drug: Fulvestrant
- intramuscular injection
- Drug: Anastrozole
- 1 mg oral tablet
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: 1
- Anastrozole monotherapy
- Experimental: 2
- Anastrozole + Fulvestrant
Outcome Measures for this Clinical Trial
Primary Measures
- Patients Event-free at 12 Months (Where Event = Death (From Any Cause), Disseminated Tumour Cells (DTC) Positive at 12 Months or Clinical Disease Recurrence)
- Time Frame: 12 month period following randomisation
Safety Issue?: No
- Time Frame: 12 month period following randomisation
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Postmenopausal women with hormone receptor-positive early breast cancer and a positive Disseminated Tumour Cell immunocytochemical result from bone marrow aspiration prior to randomisation
Exclusion Criteria:
- Inflammatory and/or metastatic breast cancer.
- Current or previous malignancy within previous 5 years (other than Breast cancer or adequately treated non-melanoma skin cancer or in-situ cervical cancer).
- History of bleeding diathesis.
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: AstraZeneca Industry
Overall Clinical Trial Officials and Contacts
Breast Cancer Established Brands Team Medical Science Director, MD Study Director AstraZeneca
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00357110
Study ID Number: D6990C00001
ClinicalTrials.gov Identifier: NCT00357110
Health Authority: Austria: Federal Ministry for Health and Women
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00357110
