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: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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

Primary Measures

• Frequency of events (Disseminated Tumour Cells present in bone marrow samples)
  • Time Frame: after 12 months of randomised treatment
    Safety Issue?: No
• Clinical recurrence and/or death
  • Time Frame: after 12 months of randomised treatment
    Safety Issue?: Yes

Secondary Measures

• Frequency of adverse events
  • Time Frame: after 12 and 24 months of randomised treatment
    Safety Issue?: Yes

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

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Breast Cancer Established Brands Team Medical Science Director, MD Study Director AstraZeneca  

Information obtained from ClinicalTrials.gov on November 19, 2008

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