S9630, Medroxyprogesterone in Treating Women With Breast Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• One of the following histologically proven diagnoses:
• * Primary invasive adenocarcinoma of the unilateral or bilateral breast
• * Stage I, IIA, or IIB (T1-3, N0-1, M0)
• * No recurrent invasive breast cancer
• * Ductal carcinoma in situ (DCIS)
• * Lobular carcinoma in situ (LCIS) with microinvasion
• * Paget's disease of the nipple
• No sarcoma, lymphoma, or apocrine, adenocystic, or squamous cell cancer of the breast
• Currently free of breast cancer (no evidence of disease)
• * No evidence of distant disease on chest x-ray or chest CT scan and mammogram of the opposite breast within the past year
• Prior definitive local treatment of primary lesion (mastectomy or breast-sparing procedure with radiotherapy) and either axillary node or sentinel node biopsy
• * Surgical margins clear of both infiltrating carcinoma (any type) and DCIS
• * No gross or microscopically positive margins except:
• * Invasive cancer or DCIS at the focal margin treated with definitive radiotherapy
• * Gross or LCIS at the final margin
• * Biopsy requirement waived for DCIS or LCIS with minimal microinvasion
• Patients with breast-sparing procedure must have received or be planning to receive radiotherapy at start of tamoxifen treatment
• No endometrial simple or cystic hyperplasia, proliferative changes, complex (adenomatous) or atypical hyperplasia, or carcinoma
• Patients must be planning one of the following:
• * Starting adjuvant tamoxifen for five years OR
• * Started tamoxifen within 28 days prior to study and planning to receive adjuvant tamoxifen for five years
• Hormone receptor status:
• * Candidate for adjuvant tamoxifen therapy
• PATIENT CHARACTERISTICS:
• Age:
• Adult
• Sex:
• Female
• Menopausal status:
• Postmenopausal defined as:
• * At least 1 year since last menstrual period
• * At least 2 months since bilateral oophorectomy prior to breast cancer diagnosis
• * 4-12 months since last menstrual period and FSH elevated to postmenopausal range
• * Postmenopausal estrogen therapy and 55 years of age or older
• Performance status:
• Not specified
• Life expectancy:
• Not specified
• Hematopoietic:
• Not specified
• Hepatic:
• Not specified
• Renal:
• Not specified
• Other:
• Fertile patients must use effective contraception during and for at least 2 months after study
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer currently in complete remission
• No concurrent nonmalignant-related illness that would preclude study
• PRIOR CONCURRENT THERAPY:
• Biologic therapy:
• Not specified
• Chemotherapy:
• Adjuvant chemotherapy allowed
• No concurrent chemotherapy
• Endocrine therapy:
• See Disease Characteristics
• No prior hormonal treatment for breast cancer (except tamoxifen)
• No concurrent postmenopausal estrogen therapy
• Radiotherapy:
• See Disease Characteristics
• Surgery:
• See Disease Characteristics
• No prior or concurrent hysterectomy
• Other:
• No prior or current participation in an adjuvant intergroup trial