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| Sponsor: | Intarcia Therapeutics |
|---|---|
| Information provided by: | Intarcia Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00044291 |
Purpose
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 |
|---|---|---|
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Arizona Clinical Research Center | |
| Tucson, Arizona, United States, 85712 | |
| Midwest Internal Medicine, PLLC | |
| Lake Havasu City, Arizona, United States, 86403 | |
| United States, California | |
| California Cancer Care, Inc. | |
| Greenbrae, California, United States, 94904-2007 | |
| Sharp Memorial Hospital | |
| San Diego, California, United States, 92123 | |
| United States, Florida | |
| Innovative Medical Research of South Florida Inc. | |
| Miami Shores, Florida, United States, 33138 | |
| United States, Georgia | |
| Georgia Cancer Specialists | |
| Tucker, Georgia, United States, 30084 | |
| United States, Maryland | |
| Maryland Hematology/Oncology Associates | |
| Baltimore, Maryland, United States, 21236 | |
| United States, Michigan | |
| Oncology Care Associates, PLLC | |
| St. Joseph, Michigan, United States, 49085 | |
| United States, Missouri | |
| Kansas City Oncology and Hematology Group | |
| Kansas City, Missouri, United States, 64131 | |
| United States, Montana | |
| Great Falls Clinic-Oncology West | |
| Great Falls, Montana, United States, 59405 | |
| United States, New York | |
| Slocum-Dickson Medical Group | |
| New Hartford, New York, United States, 13413 | |
| United States, Ohio | |
| Hematology Oncology Consultants, Inc. | |
| Columbus, Ohio, United States, 43235 | |
| United States, Texas | |
| Oncology Consultants | |
| Houston, Texas, United States, 77024 | |
| First Dynamic Healthcare Services, Inc. | |
| Killeen, Texas, United States, 76710 | |
| United States, Utah | |
| Cache Valley Cancer Treatment & Research Clinic | |
| Logan, Utah, United States, 84341 | |
| United States, Virginia | |
| Virginia Oncology Associates | |
| Norfolk, Virginia, United States, 23502 | |
| United States, Washington | |
| Western Washington Oncology Inc., P.S. | |
| Olympia, Washington, United States, 98502 | |
| Canada, Ontario | |
| Northwestern Ontario Regional Cancer Centre | |
| Thunder Bay, Ontario, Canada, P7A7T1 | |
| Ottawa Regional Cancer Centre | |
| Ottawa, Ontario, Canada, K 1H 1C4 | |
| Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Canada, Quebec | |
| McGill University, Department of Oncology | |
| Montreal, Quebec, Canada, H2W1S6 | |
| Russian Federation | |
| Petrov Research Institute of Oncology, Department of Chemotherapy | |
| St. Petersburg, Russian Federation, 197758 | |
| Petrov Research Institute of Oncology, Department of Breast Cancer | |
| St. Petersburg, Russian Federation, 197758 | |
| Central Clinical Hospital of the Ministry of Transport n.a. Semashko, Department of Chemotherapy | |
| Moscow, Russian Federation, 129128 | |
| Medical Radiological Research Center | |
| Obninsk, Russian Federation, 249036 | |
| St. Petersburg City Oncology Center | |
| St. Petersburg, Russian Federation, 197022 | |
| Blokhin Cancer Research Center, Department of Clinical Pharmacology and Chemotherapy | |
| Moscow, Russian Federation, 115478 | |
| Blokhin Cancer Research Center, Department of Chemotherapy | |
| Moscow, Russian Federation, 115478 | |
| V. Novgorod Regional Oncology Center, Department of Chemotherapy | |
| V. Novgorod, Russian Federation, 173016 | |
| Blokhin Cancer Research Center, Department of New Antitumor Drug Research | |
| Moscow, Russian Federation, 115478 | |
| Samara Regional Oncology Center, Department of Chemotherapy | |
| Samara, Russian Federation, 443066 | |
| Petrov Research Institute of Oncology, Department of Biotherapy and Bone Marrow Transplantation | |
| St. Petersburg, Russian Federation, 197758 | |
| Research Institute of Oncology, Tomsk Scientific Center, Siberian Department of the Russian Academy of Medical Sciences, Department of Chemotherapy | |
| Tomsk, Russian Federation, 634028 | |
| Stavropol Regional Oncology Center, Department of Chemotherapy | |
| Stavropol, Russian Federation, 355018 | |
| Ryazan Regional Clinical Oncology Center | |
| Ryazan, Russian Federation, 390046 | |
| Blokhin Cancer Research Center, Department of Chemotherapy and Combined Treatment of Tumors | |
| Moscow, Russian Federation, 115478 | |
| Municipal Clinical Hospital #1, Department of Breast Tumors, Oncology Department | |
| Novosibirsk, Russian Federation, 630047 | |
| Arkhangelsk Regional Oncology Center, Department of Chemotherapy | |
| Arkhangelsk, Russian Federation, 163045 | |
| Burdenko Voronezh Medical Academy, Oncology Department, Clinical Facility: Regional Clinical Oncology Center | |
| Voronezh, Russian Federation, 394000 | |
| Hertzen Research Institute of Oncology, Department of Chemotherapy | |
| Moscow, Russian Federation, 125284 | |
| Tatarstan Republican Clinical Oncology Center | |
| Kazan, Russian Federation, 420029 | |
| N. Novgorod City Oncology Center, Department of Chemotherapy | |
| N. Novgorod, Russian Federation, 603000 | |
| Leningrad Regional Oncology Center | |
| Leningrad, Russian Federation, 188663 | |
| Moscow City Oncology Hospital #62 | |
| Moscow, Russian Federation, 143423 | |
| Laboratory of Thoracic Oncology, St. Petersburg Pavlov State Medical University, Research Institute of Pulmonology | |
| St. Petersburg, Russian Federation, 197089 | |
| Murmansk Regional Oncology Center | |
| Murmansk, Russian Federation, 183047 | |
| Moscow City Hospital #40, Department of Chemotherapy | |
| Moscow, Russian Federation, 129301 | |
| Krasnodar Regional Clinical Oncology Center, Chemotherapy Department | |
| Krasnodar, Russian Federation, 350040 | |
| Lipetsk Regional Oncology Center, Department of General Oncology | |
| Lipetsk, Russian Federation, 398005 | |
| Ukraine | |
| Dnepropetrovsk State Medical Academy, Oncology Department. Clinical Facility: Dnepropetrovsk City Clinical Hospital #4 | |
| Dnepropetrovsk, Ukraine, 49102 | |
| National Medical University, Oncology Department. Clinical Facility: Kiev City Oncology Hospital, Surgery Department | |
| Kiev, Ukraine, 03115 | |
| Kharkov Medical Academy of Postgraduate Education, Oncology and Pediatric Oncology Department. Clinical Facility: Kharkov Regional Clinical Oncology Dispensary, Chemotherapy Department | |
| Kharkov, Ukraine, 61070 | |
| Kiev Postgraduate Studies Medical Academy. Clinical Facility: Kiev City Oncology Hospital, Chemotherapy Department | |
| Kiev, Ukraine, 03115 | |
| Kharkov State Medical University. Clinical Facility: Grigoriev Medical Radiology Institute, Chemotherapy Department | |
| Kharkov, Ukraine, 61024 | |
| Donetsk State Medical University. Clinical Facility: Donetsk Regional Antineoplastic Center, Mammology Department | |
| Donetsk, Ukraine, 83092 | |
| Lviv State Medical University, Oncology and Medical Radiology Department. Clinical Facility: Lviv State Oncology Regional Clinical Diagnostic Center, Chemotherapy Department | |
| Lviv, Ukraine, 79031 | |
| Krivoy Rog City Oncology Center | |
| Krivoy Rog, Ukraine, 50048 | |
| Kiev Oncology Institute, Ukraine Medical Science Academy, Department of Breast Tumors | |
| Kiev, Ukraine, 03022 | |
| Kiev Central Clinical Hospital, Ukraine Security Services, Surgery Department | |
| Kiev, Ukraine, 01021 | |
| Zaporozhye Statue Institute of Postgraduate Training. Oncology Department; Clinical Facility: Zaporozhye Regional Oncology Center | |
| Zaporozhye, Ukraine, 69104 | |
| Uzhgorod National University Oncology Course of Surgery Department of Postgraduate Education Faculty Clinical Facility: Zakarpatye Regional Oncology Center | |
| Uzhgorod, Ukraine, 88000 | |
| Cherkassy Regional Oncology Center, Chemotherapy Department | |
| Cherkassy, Ukraine, 18009 | |
| Ivano-Frankovsk State Medical Academy; Oncology Department Clinical Facility: Ivano-Frankovsk Regional Oncology Center | |
| Ivano-Frankovsk, Ukraine, 76000 | |
| Odessa State Medical University, Oncology Department. Clinical Facility: Odessa Regional Oncology Center, Chemotherapy Department | |
| Odessa, Ukraine, 65055 | |
| Study Chair: | Paul Goss, M.D. | Princess Margaret Hospital, Canada |
More Information
| Study ID Numbers: | Biomed 777-CLP-29 |
| Study First Received: | August 23, 2002 |
| Last Updated: | August 21, 2007 |
| ClinicalTrials.gov Identifier: | NCT00044291 History of Changes |
| 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 |
|
Estrogen Antagonists Antineoplastic Agents, Hormonal Molecular Mechanisms of Pharmacological Action Skin Diseases Antineoplastic Agents Atamestane Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Breast Neoplasms Bone Density Conservation Agents Enzyme Inhibitors |
Letrozole Selective Estrogen Receptor Modulators Toremifene Pharmacologic Actions Estrogen Receptor Modulators Neoplasms Neoplasms by Site Neoplasms, Hormone-Dependent Therapeutic Uses Aromatase Inhibitors Breast Diseases |