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Sponsored by: |
Intarcia Therapeutics |
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Information provided by: | Intarcia Therapeutics |
ClinicalTrials.gov Identifier: | NCT00044291 |
The purpose of this study is to determine whether the first line combination hormonal therapy of an experimental drug, atamestane, plus an FDA-approved drug, toremifene (Fareston®), is more effective than another approved drug, letrozole (Femara®), in delaying the growth of breast cancer in postmenopausal patients with locally advanced or metastatic breast cancer, and whether the side effects of the combination are different from the side effects of letrozole.
Condition | Intervention | Phase |
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Breast Neoplasms Neoplasms, Hormone-Dependent |
Drug: atamestane Drug: toremifene Drug: letrozole Drug: aromatase inhibition Procedure: hormone therapy Procedure: endocrine therapy Procedure: antiestrogen therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 842 |
Study Start Date: | June 2002 |
Study Completion Date: | January 2006 |
Arms | Assigned Interventions |
---|---|
Atamestane + toremifene: Experimental | Drug: atamestane Drug: toremifene Drug: aromatase inhibition Procedure: hormone therapy Procedure: endocrine therapy Procedure: antiestrogen therapy |
Letrozole + placebo: Active Comparator | Drug: letrozole Drug: aromatase inhibition Procedure: hormone therapy Procedure: endocrine therapy |
Breast cancer cells are often very dependent on estrogens to continue to grow. Atamestane blocks the formation of estrogens and androgenic precursors in the body. Toremifene blocks circulating and intracellular estrogens from stimulating estrogen receptors in breast cancer cells. The goal of therapy with atamestane, an aromatase inhibitor, in combination with the estrogen receptor antagonist, toremifene, is to achieve maximal suppression of estrogen stimulation of breast cancer cells. This study is designed to determine whether combination therapy will lengthen the time to disease progression and the rate of objective response compared to single agent aromatase inhibitor therapy with letrozole.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Chair: | Paul Goss, M.D. | Princess Margaret Hospital, Canada |
Study ID Numbers: | Biomed 777-CLP-29 |
Study First Received: | August 23, 2002 |
Last Updated: | August 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00044291 |
Health Authority: | United States: Food and Drug Administration |
Atamestane Toremifene Letrozole Aromatase inhibitor Receptor-positive First line therapy Estrogen blocker Metastatic breast cancer |
Locally advanced breast cancer Locally recurrent breast cancer stage IV breast cancer ductal breast carcinoma lobular breast carcinoma stage IIIA breast cancer stage IIIB breast cancer recurrent breast cancer |
Carcinoma, Lobular Skin Diseases Atamestane Neoplasms, Hormone-Dependent Breast Neoplasms Letrozole |
Carcinoma, Ductal, Breast Toremifene Breast Diseases Recurrence Carcinoma |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Bone Density Conservation Agents Enzyme Inhibitors |
Selective Estrogen Receptor Modulators Pharmacologic Actions Estrogen Receptor Modulators Neoplasms Neoplasms by Site Therapeutic Uses Aromatase Inhibitors |