TRIAL 16 (S.A.L.S.A)

Coordinating Investigator: M. Gnant

Secondary Adjuvant Longterm Study with Anastrozole (S.A.L.S.A) in postmenopausal, hormone receptor-positive breast cancer patients
Trial start:	February '04
TRIAL OBJECTIVES	Primary objective: To compare disease-free survival Secondary objectives: • To compare overall survival • To compare fracture rates • To compare the emergence of secondary and contralateral cancers
TRIAL DESIGN	Prospectively randomized, open-lable, multicenter, Phase III trial Stratification criteria: Tumor stage, lymph node status, receptor status, adjuvant primary hormonal treatment, adjuvant chemotherapy, previous participation in an ABCSG trial, participating Austrian federal province
TIMETABLE	Recruitment period: February 2004 – February 2009 End of treatment period: February 2014 End of follow-up: February 2019
PATIENTS	3.500
INCLUSION CRITERIA	• Postmenopausal, hormone receptor-positive patients • Histologically verified (minimally) invasive breast cancer, local radical treatment • Endocrine treatment for 5 years (max. deviation +/- 12 months) • Treatment holiday (prior to pretreatment) ≤ 12 months • Freedom of recurrence at randomization• Age < 80 years
EXCLUSION CRITERIA	• In situ carcinoma, T4 at first diagnosis; M1 at randomization • Unknown or negative receptor status at diagnosis and/or begin of primary endocrine treatment • General contraindications against and/or hypersensitivity to anastrozole • Regular hormone preparation intake or hormone replacement therapy