ICI 182780 in Treating Women With Metastatic Breast Cancer

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