Fulvestrant in Premenopausal Women With Hormone Receptor-Positive Breast Cancer
A Phase II Study of Fulvestrant in Premenopausal Women With Hormone Receptor-Positive Breast Cancer
1 other identifier
interventional
35
1 country
4
Brief Summary
The purpose of this study is to test the effectiveness and safety of fulvestrant in premenopausal women with advanced breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 breast-cancer
Started Jun 2004
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 6, 2005
CompletedFirst Posted
Study publicly available on registry
September 7, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedDecember 21, 2007
December 1, 2007
3.1 years
September 6, 2005
December 20, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
To determine the safety, time-to-progression, and duration of response for this patient population
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- Beth Israel Deaconess Medical Centercollaborator
- Massachusetts General Hospitalcollaborator
- Lowell General Hospitalcollaborator
- Brigham and Women's Hospitalcollaborator
Study Sites (4)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Massachusetts General Hospital
Boston, Massachusetts, 02115, United States
Lowell General Hospital
Lowell, Massachusetts, 01854, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Craig A. Bunnell, MD
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 6, 2005
First Posted
September 7, 2005
Study Start
June 1, 2004
Primary Completion
July 1, 2007
Study Completion
July 1, 2007
Last Updated
December 21, 2007
Record last verified: 2007-12