Status:
COMPLETED
Fulvestrant in Premenopausal Women With Hormone Receptor-Positive Breast Cancer
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to test the effectiveness and safety of fulvestrant in premenopausal women with advanced breast cancer.
Detailed Description
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 blo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2007
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00146601
Start Date
June 1 2004
End Date
July 1 2007
Last Update
December 21 2007
Active Locations (4)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
4
Lowell General Hospital
Lowell, Massachusetts, United States, 01854