Adjuvant Tamoxifen Compared With Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ

DISEASE CHARACTERISTICS:

• Diagnosis of ductal carcinoma in situ within the past 6 months

• Locally excised with tumor-free margins at least 1 mm

• Hormone receptor status:

• Estrogen or progesterone receptor positive

• Equal to or greater than 5% positive cells

PATIENT CHARACTERISTICS:

Age

• 40 to 70

Sex

• Female

Menopausal status

• Postmenopausal, defined as meeting at least 1 of the following criteria:

• Over age 60

• Prior bilateral oophorectomy

• Age 60 or under with a uterus AND amenorrhea for at least the past 12 months

• Age 60 or under without a uterus AND follicle-stimulating hormone greater than 20 IU/L

Performance status

• Not specified

Life expectancy

• At least 10 years

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Cardiovascular

• No prior deep vein thrombosis

• No prior transient ischemic attack

• No prior cerebrovascular accident

Pulmonary

• No prior pulmonary embolism

Other

• No unexplained postmenopausal bleeding

• No other cancer within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix

• No other concurrent medical condition that would preclude study therapy, place the patient at unusual risk, or confound study results

• No evidence of osteoporosis

• Fragility fractures within the spine allowed if T-score level is greater than -4 and consist of no more than 2 fractures

• Psychologically and physically suitable for 5 years of study therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• No prior or concurrent tamoxifen use lasting more than 6 months unless treatment was completed more than 5 years ago. Women in IBIS-I can join if off trial therapy for at least 5 years.

• No prior or concurrent raloxifene use lasting more than 6 months unless treatment was completed more than 5 years ago.

• No other prior or concurrent selective estrogen-receptor modulator use lasting more than 6 months unless treatment was completed more than 5 years ago

• No concurrent systemic estrogen-based hormone replacement therapy, including vaginal estrogen preparations

Radiotherapy

• Not specified

Surgery

• See Disease Characteristics

• No prior mastectomy

• No planned prophylactic mastectomy

Other

• At least 3 months since prior unapproved or experimental agents

• No concurrent anticoagulants