IBCSG 30-04 / NCIC CTG MA.27

Phase 3

Completed

• Conditions: Receptor positive primary breast cancer; Cancer - Breast

• Registration Number: ACTRN12605000389606
• Lead Sponsor: Australia and New Zealand Breast Cancer Trials Group Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-14
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 5800

Inclusion Criteria

Postmenopausal women with completely resected, histologically proven, hormone receptor-positive primary breast cancer who have a minimum life expectancy of 5 years and are accessible for follow up.

Exclusion Criteria

Premenopausal women; patients with only receptor negative primary tumours; patients with locally recurrent or metastatic breast cancer; patients with history of other (non-breast) malignancies; patients receiving concurrent hormonal therapy with estrogens, progesterones, androgens, or SERMs; patients having received prior treatment with a recognised aromatase inhibitor; any prior treatment with tamoxifen or SERMS other than raloxifene; any prior treatment with hormones or steroids if not discontinued at least 3 weeks prior to randomization; patients with a prior diagnosis of an in-situ carcinoma in the contralateral breast treated with partial mastectomy and/or hormonal therapy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare event free survival between women treated with exemestane or anastrozole as adjuvant therapy. The total duration of the study will be about 5 years.[It will be measured when 847 events have been observed. It is estmated that 3.2 years of accrual and another 2 years of follow up will be required.]