Fulvestrant in Premenopausal Women With Hormone Receptor-Positive Breast Cancer
NCT ID: NCT00146601
Last Updated: 2007-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
35 participants
INTERVENTIONAL
2004-06-30
2007-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Fulvestrant
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Beth Israel Deaconess Medical Center
OTHER
Massachusetts General Hospital
OTHER
Lowell General Hospital
OTHER
Brigham and Women's Hospital
OTHER
Dana-Farber Cancer Institute
OTHER
Principal Investigators
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Craig A. Bunnell, MD
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Lowell General Hospital
Lowell, Massachusetts, United States
Countries
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Other Identifiers
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04-075
Identifier Type: -
Identifier Source: org_study_id