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Study 12 of 223 for search of: | United States, Alaska |
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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) National Cancer Institute of Canada |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00075764 |
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using drugs such as anastrozole and fulvestrant may fight breast cancer by blocking the use of estrogen. It is not yet known whether anastrozole is more effective with or without fulvestrant in treating breast cancer.
PURPOSE: This randomized phase III trial is studying giving anastrozole together with fulvestrant to see how well it works compared to anastrozole alone as first-line therapy in treating postmenopausal women with metastatic breast cancer.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: anastrozole Drug: fulvestrant |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Phase III Randomized Trial of Anastrozole Versus Anastrozole and Fulvestrant as First Line Therapy for Post Menopausal Women With Metastatic Breast Cancer |
Estimated Enrollment: | 690 |
Study Start Date: | April 2004 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Active Comparator
Patients receive oral anastrozole once daily on days 1-28.
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Drug: anastrozole
Given orally
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Arm II: Experimental
Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses.
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Drug: anastrozole
Given orally
Drug: fulvestrant
Given intramuscularly
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OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior adjuvant tamoxifen therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.
In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed for up to 4 years.
PROJECTED ACCRUAL: A total of 690 patients (345 per treatment arm) will be accrued for this study within 3 years.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed breast cancer meeting 1 of the following criteria:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Postmenopausal, as defined by 1 of the following:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
At least 12 months since prior adjuvant luteinizing hormone-releasing hormone (LHRH) analogues
Radiotherapy
Surgery
Other
Investigator: | Rita S. Mehta, MD | Chao Family Comprehensive Cancer Center |
Study Chair: | Theodore A. Vandenberg, MD | London Regional Cancer Program at London Health Sciences Centre |
Study ID Numbers: | CDR0000349337, SWOG-S0226, CAN-NCIC-MAC7 |
Study First Received: | January 9, 2004 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00075764 |
Health Authority: | Unspecified |
stage IV breast cancer recurrent breast cancer |
Anastrozole Skin Diseases Fulvestrant Breast Neoplasms |
Menopause Breast Diseases Recurrence |
Estrogen Antagonists Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists |
Enzyme Inhibitors Pharmacologic Actions Estrogen Receptor Modulators Neoplasms Neoplasms by Site Therapeutic Uses Aromatase Inhibitors |