Fulvestrant in Premenopausal Women With Hormone Receptor-Positive Breast Cancer

Study Overview
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Brief Summary
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The purpose of this study is to test the effectiveness and safety of fulvestrant in premenopausal women with advanced breast cancer.

Detailed Description
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Patients will receive an injection of fulvestrant on first day of treatment and then again 2 weeks later and again 2 weeks after that. Then patients will receive injections every 4 weeks. Routine blood tests will be performed each time an injection is given. Patients will be required to complete a hot flash diary, recording the number and severity of hot flashes they experience on a daily basis. After every 12 weeks of treatment, patients' disease will be assessed by x-rays or scans. If there is no disease progression, the patient will continue to receive injections every 4 weeks with reassessment every 8 weeks. Patients will continue to receive treatment as long as there is no disease progression or serious side effects.

Official Title
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A Phase II Study of Fulvestrant in Premenopausal Women With Hormone Receptor-Positive Breast Cancer

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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Inclusion Criteria: Histologically or cytologically confirmed invasive breast cancer, with stage IV disease. Tumors must be positive for estrogen receptors, progesterone receptors, or both. Patients must be premenopausal. Prior anti-estrogen therapy (with or without ovarian suppression) Platelet count > 100,000/mm3 Age older than 18 years ECOG performance status 0-2 Exclusion Criteria: Hormonal treatment for metastatic disease Pregnant or breast-feeding women Postmenopausal Concurrent hormonal therapy or chemotherapy Prior fulvestrant therapy More than three prior chemotherapy regimens for metastatic disease Concurrent, long-term anticoagulation therapy Severe, uncontrolled intercurrent illness History of hypersensitivity to castor oil

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fulvestrant|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine the clinical benefit and response rate of hormone receptor-positive metastatic breast cancer previously treated with anti-estrogen therapy in premenopausal women to treatment with fulvestrant |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the safety, time-to-progression, and duration of response for this patient population |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fulvestrant, Advanced breast cancer, Invasive breast cancer, Stage IV Breast Cancer, Hormone Receptor-Positive Breast Cancer