ICI 182780 in Treating Women With Metastatic Breast Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically or cytologically confirmed adenocarcinoma of the breast
• * Progressive local-regional or metastatic disease
• * Unconfirmed new or progressive multiple pulmonary nodules or unequivocal radiographic evidence of multiple bone metastases allowed
• At least 1 measurable lesion
• * At least 20 mm by CT scan or MRI OR at least 10 mm by spiral CT scan
• * Nonmeasurable disease includes the following:
• * Bone lesions
• * Leptomeningeal disease
• * Ascites
• * Pleural/pericardial effusions
• * Lymphangitis cutis/pulmonis
• * Inflammatory breast disease
• * Abdominal masses not confirmed and followed by imaging techniques
• * Cystic lesions
• Disease progression after prior third-generation aromatase inhibitor (e.g., anastrozole, exemestane, letrozole, or vorozole)
• * Failed no more than 1 prior additive hormonal therapy (e.g., aromatase inhibitor with or without tamoxifen)
• * Disease recurrence identified no more than 12 months since the last prior adjuvant tamoxifen treatment
• * Oophorectomy, ovarian radiotherapy, and luteinizing hormone-releasing hormone (LH-RH) analogs not considered hormonal therapy regimens
• No brain or leptomeningeal metastases
• No hepatic metastases involving more than one-third of the liver
• No symptomatic pulmonary lymphangitic disease
• Evidence of hormone sensitivity as defined by:
• * Relapse after at least 12 months of adjuvant hormonal treatment
• * Tumor remission or stabilization before progression for at least 6 months after prior hormonal therapy for advanced disease
• Postmenopausal as defined by one of the following:
• * At least 12 months since last menstrual period
• * 4-11 months since last menstrual period and follicle-stimulating hormone (FSH) in the postmenopausal range
• * Prior castration and castrate FSH levels within the postmenopausal range
• * Hysterectomy without oophorectomy (FSH in postmenopausal range if age 60 and under)
• Hormone receptor status:
• * Estrogen-receptor and/or progesterone-receptor positive
• * At least 10 fmol/mg cytosol protein OR
• * Positive by immunohistochemistry
• PATIENT CHARACTERISTICS:
• Age:
• 18 and over
• Sex:
• Female
• Menopausal status:
• See Disease Characteristics
• Postmenopausal
• Performance status:
• ECOG 0-2
• Life expectancy:
• At least 3 months
• Hematopoietic:
• WBC at least 2,000/mm\^3
• Platelet count at least 100,000/mm\^3
• No history of bleeding diathesis
• Hepatic:
• See Disease Characteristics
• Bilirubin no greater than 0.8 mg/dL above upper limit of normal (ULN)
• INR no greater than 1.6
• No hepatitis B or C
• No severe hepatic impairment
• Renal:
• Calcium no greater than 10% above ULN
• Creatinine no greater than 1 mg/dL above ULN
• No severe renal impairment
• Cardiovascular:
• No unstable or uncompensated cardiac condition
• Pulmonary:
• No unstable or uncompensated respiratory condition
• Other:
• HIV negative
• No AIDS
• No other severe condition or systemic disease that would preclude study participation
• PRIOR CONCURRENT THERAPY:
• Biologic therapy:
• Prior trastuzumab (Herceptin) allowed
• Chemotherapy:
• Prior adjuvant chemotherapy allowed
• No more than 1 prior chemotherapy regimen for metastatic disease
• Endocrine therapy:
• See Disease Characteristics
• More than 4 weeks since prior estrogen replacement therapy
• More than 3 months since prior LH-RH analogs
• No other prior additive hormonal therapy except third-generation aromatase inhibitors or tamoxifen
• Radiotherapy:
• See Disease Characteristics
• Concurrent radiotherapy for control of bone pain or other reasons due to established bone lesions allowed if radiotherapy field is no more than 30% of bone marrow
• Surgery:
• See Disease Characteristics
• Other:
• More than 4 weeks since prior investigational drug for breast cancer
• No concurrent long-term warfarin
• Concurrent bisphosphonates allowed if dose stable
• Concurrent long-term antiplatelet therapy allowed