Anastrozole and Fulvestrant Compared to Anastrozole as Adjuvant Treatment of Postmenopausal Patients With Breast Cancer

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.

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.