ICI 182780 in Treating Women With Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Estradiol; Fulvestrant

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