Fulvestrant in Premenopausal Women With Hormone Receptor-Positive Breast Cancer
This study has been completed.
Sponsor:
Dana-Farber Cancer Institute
Collaborators:
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Lowell General Hospital
Brigham and Women's Hospital
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00146601
First received: September 6, 2005
Last updated: December 20, 2007
Last verified: December 2007
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Purpose
The purpose of this study is to test the effectiveness and safety of fulvestrant in premenopausal women with advanced breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: Fulvestrant |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Fulvestrant in Premenopausal Women With Hormone Receptor-Positive Breast Cancer |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Fulvestrant
U.S. FDA Resources
Further study details as provided by Dana-Farber Cancer Institute:
Primary Outcome Measures:
- 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:
- To determine the safety, time-to-progression, and duration of response for this patient population
| Estimated Enrollment: | 35 |
| Study Start Date: | June 2004 |
| Study Completion Date: | July 2007 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00146601
Locations
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02115 | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| Lowell General Hospital | |
| Lowell, Massachusetts, United States, 01854 | |
Sponsors and Collaborators
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Lowell General Hospital
Brigham and Women's Hospital
Investigators
| Principal Investigator: | Craig A. Bunnell, MD | Dana-Farber Cancer Institute |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00146601 History of Changes |
| Other Study ID Numbers: | 04-075 |
| Study First Received: | September 6, 2005 |
| Last Updated: | December 20, 2007 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Dana-Farber Cancer Institute:
|
Fulvestrant Advanced breast cancer Invasive breast cancer Stage IV Breast Cancer Hormone Receptor-Positive Breast Cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Hormones Estradiol Fulvestrant Hormones, Hormone Substitutes, and Hormone Antagonists |
Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Estrogen Antagonists Estrogen Receptor Modulators Hormone Antagonists Antineoplastic Agents, Hormonal Estrogens |
ClinicalTrials.gov processed this record on May 16, 2013