Exemestane Compared With Tamoxifen in Treating Women With Locally Recurrent or Metastatic Breast Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically or cytologically proven adenocarcinoma of the breast that is metastatic and progressive or locally recurrent and inoperable
• •At least one bidimensionally measurable or evaluable lesion
• •* Lytic bone lesions on x-ray/CT scan, surrounded by calcified bone, and at least 1 cm
• •* Bidimensionally measurable extraosseous disease required for patients on bisphosphonates
• •* The following are not considered evaluable:
• •* Previously irradiated lesions
• •* Lymphangitic spread
• •* Ascites
• •* Blastic bone lesions
• •* Pleural effusions
• •No rapidly progressive disease for which hormonal therapy is not indicated
• •No massive visceral disease (i.e., more than one third of any organ)
• •No brain metastases
• •Hormone receptor status:
• •* Estrogen receptor positive or progesterone receptor positive, defined by 1 of the following:
• •* At least 10 femtomoles H3-estrogen or at least 20 femtomoles
• •* H3 progesterone binding per mg of cytosol protein by DCC or sucrose density method
• •* At least 0.10 femtomoles H3-estrogen or at least 0.20 femtomoles
• •* H3-progesterone binding per mg of DNA by IF/EIA technique
• •* Positive immunohistochemistry noted on pathology report
• •* Unknown receptor status eligible provided:
• •* Disease-free interval of at least 2 years since adjuvant therapy or initial surgery (if no adjuvant therapy), including most recently treated tumor in bilateral breast cancer if status unknown in one primary tumor
• •PATIENT CHARACTERISTICS:
• •Age:
• •18 and over
• •Sex:
• •Female
• •Menopausal status:
• •Postmenopausal by 1 of the following:
• •* Natural menopause and more than 1 year since last menstrual period (LMP)
• •* Radiation-induced oophorectomy and more than 1 year since LMP
• •* Chemotherapy induced menopause if:
• •* At least 1 year since LMP (+ 1 year post-tamoxifen)
• •* Serum FSH and LH and plasma estradiol levels in postmenopausal range
• •* LHRH-induced amenorrhea
• •* Surgical castration
• •* Patients under age 56 with prior hysterectomy and 1 or both ovaries intact or tamoxifen-induced amenorrhea with at least 12 months since prior tamoxifen must have postmenopausal serum FSH and LH and plasma estradiol concentrations
• •Performance status:
• •ECOG (WHO) 0-2
• •Hematopoietic:
• •Absolute neutrophil count at least 1,500/mm\^3
• •Platelet count at least 100,000/mm\^3
• •Hepatic:
• •Bilirubin less than 1.5 times upper limit of normal (ULN)
• •SGOT/SGPT less than 2.5 times ULN (less than 5 times ULN with liver metastases)
• •Renal:
• •Creatinine less than 1.5 times ULN
• •Cardiovascular:
• •No deep venous thrombosis
• •Other:
• •No mental incapacitation
• •No severe concurrent disease
• •No prior or concurrent malignancy except curatively treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy:
• •No concurrent immunotherapy
• •Chemotherapy:
• •See Disease Characteristics
• •At least 3 weeks since chemotherapy for metastatic disease and recovered
• •No more than 1 prior chemotherapy regimen for metastatic disease
• •Prior adjuvant chemotherapy allowed if disease free for at least 6 months
• •No concurrent chemotherapy
• •Endocrine therapy:
• •No prior hormonal therapy for advanced disease (e.g., tamoxifen or LHRH agonists)
• •Prior adjuvant tamoxifen allowed if disease free for at least 6 months
• •No other concurrent hormonal therapy, including steroids
• •Radiotherapy:
• •Recovered from toxic effects of prior radiotherapy
• •Concurrent palliative radiotherapy, including whole brain irradiation, allowed
• •Surgery:
• •See Disease Characteristics
• •No prior ovariectomy for advanced disease
• •Other:
• •No other concurrent investigational drugs
• •Concurrent bisphosphonates allowed if short term (7 days) for hypercalcemia due to suspect tumor flare or if on prior bisphosphonates with bidimensionally measurable extraosseous lesion