ICI 182780 in Treating Women With Metastatic Breast Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: fulvestrant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fulvestrant<br>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. | Drug: fulvestrant<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective response rate |  | Up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | Up to 10 years | 
| time to disease progression |  | Up to 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV breast cancer, recurrent breast cancer, stage IIIB breast cancer, stage IIIC breast cancer