None listed
Conditions
Brief summary
For further information, please see www.clinicaltrials.gov NCT00066573
Interventions
IBCSG 30-04 / NCIC CTG MA.27 is co-ordinated by the National Cancer Institute of Canada, Clinical Trials Group (NCIC CTG). The International Breast Cancer Study Group (IBCSG) is participating in the NCIC CTG MA.27 trial, and the ANZ Breast Cancer Trials Group (ANZ BCTG) contribution is part of the IBCSG collaboration. The trial is conducted in Australia and New Zealand by the ANZ Breast Cancer Trials Group.
This study will investigate which of two drugs (exemestane and anastrozole), if either
IBCSG 30-04 / NCIC CTG MA.27 is co-ordinated by the National Cancer Institute of Canada, Clinical Trials Group (NCIC CTG). The International Breast Cancer Study Group (IBCSG) is participating in the NCIC CTG MA.27 trial, and the ANZ Breast Cancer Trials Group (ANZ BCTG) contribution is part of the IBCSG collaboration. The trial is conducted in Australia and New Zealand by the ANZ Breast Cancer Trials Group. This study will investigate which of two drugs (exemestane and anastrozole), if either, is better at preventing a recurrence of breast cancer in postmenopausal women with receptor positive, adequately excised, primary breast cancer. IBCSG 30-04 / NCIC CTG MA.27 is an international, multicentre, randomised phase III clinical trial of 5800 postmenopausal women who have had histologically or cytologically confirmed, receptor-positive primary breast cancer. Women will be randomised in a 2-arm design to receive one of the following: a. Exemestane 25mg b. Anastrozole 1mg All treatment will be on a daily basis for 5 years until recurrence or second malignancy is documented.
Sponsors
Australia and New Zealand Breast Cancer Trials Group Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed