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Sponsors and Collaborators: |
Beth Israel Deaconess Medical Center Dana-Farber Cancer Institute Faulkner Hospital Massachusetts General Hospital Lowell General Hospital University of Colorado at Denver and Health Sciences Center University of Maryland Greenebaum Cancer Center South Shore Hospital |
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Information provided by: | Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00585507 |
Fulvestrant has proven effective in the treatment of hormone receptor positive metastatic breast cancer. The dose used in studies so far has been well tolerated and may be too low for optimal effectiveness. In this study, a higher dose will be used to see whether an improved outcome will result.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: Fulvestrant |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Multi-Center Study to Evaluate the Efficacy and Safety of 500mg of Fulvestrant (Faslodex) as a First Line Hormonal Treatment in Postmenopausal Women With Hormone Receptor Positive Metastatic Breast Cancer |
Estimated Enrollment: | 40 |
Study Start Date: | April 2004 |
Estimated Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02115 | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
Massachusetts General Hosptial | |
Boston, Massachusetts, United States, 02114 | |
Lowell General Hospital | |
Lowell, Massachusetts, United States | |
South Shore Hospital | |
S. Weymouth, Massachusetts, United States |
Principal Investigator: | Steven Come, MD | Beth Israel Deaconess Medical Center |
Responsible Party: | Beth Israel Deaconess Medical Center ( Steven Come, MD ) |
Study ID Numbers: | 04-016 |
Study First Received: | December 22, 2007 |
Last Updated: | October 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00585507 History of Changes |
Health Authority: | United States: Institutional Review Board |
hormone receptor positive breast cancer Fulvestrant |
Estrogen Receptor Modulators Estrogen Antagonists Estrogens Antineoplastic Agents, Hormonal Skin Diseases Hormone Antagonists |
Hormones, Hormone Substitutes, and Hormone Antagonists Fulvestrant Breast Neoplasms Hormones Breast Diseases |
Estrogen Antagonists Antineoplastic Agents, Hormonal Skin Diseases Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Fulvestrant Hormones, Hormone Substitutes, and Hormone Antagonists |
Breast Neoplasms Hormones Pharmacologic Actions Estrogen Receptor Modulators Neoplasms Neoplasms by Site Therapeutic Uses Breast Diseases |