Trial 15 (international: IBIS II)

Coordinating Investigator: M. Stierer

Tamoxifen vs. anastrozole in postmenopausal patients with ductal carcinoma in situ (DCIS): A comparison of efficacy and tolerability
Trial start:	October '04
TRIAL OBJECTIVES	Primary objectives: • To assess whether anastrozole is as efficient as tamoxifen in locally controlling and preventing contralateral breast cancer after resection for hormone receptor-positive DCIS • To compare side effect profiles Secondary objectives: • To compare effectiveness with regard to the receptor status of primary cancers and recurrences • To examine the rates of breast cancer recurrences and contralateral tumors after discontinuation of treatment • To examine the effects on breast cancer mortality • To examine the effects on other cancers, cardiovascular disease, fracture rates and non-breast cancer-related deaths • To examine tolerability and the acceptability of side effects
TRIAL DESIGN	Multicenter, prospectively randomized, double-dummy, Phase III study Stratification criterion: Investigational site
PATIENTS	600 patients in Austria (4,000 throughout international trial)
INCLUSION CRITERIA	• Postmenopausal, hormone receptor-positive patients • DCIS removed within past 6 months • Bone mineral density measurement within past 2 years
EXCLUSION CRITERIA	• Any cancer disease within past 5 years • Concurrent treatment with anticoagulants • Previous deep vein thrombosis, pulmonary embolism, transient ischemic attack, apoplexy • Continued estrogen-based hormone replacement therapy