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ICI 182780 in Treating Women With Metastatic Breast Cancer

Phase II Trial Of Fulvestrant (Faslodex) In Women With Metastatic Breast Cancer And Failure on Aromatase Inhibitor Therapy

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00012025
Enrollment
80
Registered
2003-01-27
Start date
2001-05-31
Completion date
2008-08-31
Last updated
2016-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

stage IV breast cancer, recurrent breast cancer, stage IIIB breast cancer, stage IIIC breast cancer

Brief 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.

Detailed description

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.

Interventions

DRUGfulvestrant

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Alliance for Clinical Trials in Oncology
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
objective response rateUp to 10 years

Secondary

MeasureTime frame
overall survivalUp to 10 years
time to disease progressionUp to 10 years

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026