ici 182780 in treating women with metastatic breast cancer

Conditions: Breast Cancer

Summary: rationale: estrogen can stimulate the growth of breast cancer cells. hormone therapy using ici 182780 may fight breast cancer by blocking the activity of estrogen in the tumor cells. purpose: phase ii trial to study the effectiveness of ici 182780 in treating patients who have metastatic breast cancer that has not responded to previous hormone therapy.

objectives: * determine the complete and partial objective response rate and duration of response in women with metastatic breast cancer who have failed aromatase inhibitor therapy treated with fulvestrant. * determine the time to disease progression and overall survival of women treated with this drug. * determine the toxicity of this drug in these women. outline: patients receive fulvestrant intramuscularly on day 1. courses repeat approximately every 28 days in the absence of disease progression or unacceptable toxicity. patients are followed every 3 months for 5 years or until disease progression. after disease progression, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Eligibility criteria:
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

Keywords: stage iv breast cancer recurrent breast cancer stage iiib breast cancer stage iiic breast cancer