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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00146601 |
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Date of registration:
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06/09/2005 |
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Primary sponsor: |
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Public title:
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Fulvestrant in Premenopausal Women With Hormone Receptor-Positive Breast Cancer
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Scientific title:
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A Phase II Study of Fulvestrant in Premenopausal Women With Hormone Receptor-Positive Breast Cancer |
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Date of first enrolment:
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June 2004 |
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Target sample size:
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35 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00146601 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Craig A. Bunnell, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Dana-Farber Cancer Institute |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Cancer
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Intervention(s)
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Drug: Fulvestrant
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Primary Outcome(s)
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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
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Secondary Outcome(s)
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To determine the safety, time-to-progression, and duration of response for this patient population
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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