Spots Global Cancer Trial Database for Phase III Study of Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer
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Trial Identification
Brief Title: Phase III Study of Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer
Official Title:
Study ID: NCT00044291
Study Description
Brief Summary: 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.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Midwest Internal Medicine, PLLC, Lake Havasu City, Arizona, United States
Arizona Clinical Research Center, Tucson, Arizona, United States
California Cancer Care, Inc., Greenbrae, California, United States
Sharp Memorial Hospital, San Diego, California, United States
Innovative Medical Research of South Florida Inc., Miami Shores, Florida, United States
Georgia Cancer Specialists, Tucker, Georgia, United States
Maryland Hematology/Oncology Associates, Baltimore, Maryland, United States
Oncology Care Associates, PLLC, St. Joseph, Michigan, United States
Kansas City Oncology and Hematology Group, Kansas City, Missouri, United States
Great Falls Clinic-Oncology West, Great Falls, Montana, United States
Slocum-Dickson Medical Group, New Hartford, New York, United States
Hematology Oncology Consultants, Inc., Columbus, Ohio, United States
Oncology Consultants, Houston, Texas, United States
First Dynamic Healthcare Services, Inc., Killeen, Texas, United States
Cache Valley Cancer Treatment & Research Clinic, Logan, Utah, United States
Virginia Oncology Associates, Norfolk, Virginia, United States
Western Washington Oncology Inc., P.S., Olympia, Washington, United States
Ottawa Regional Cancer Centre, Ottawa, Ontario, Canada
Northwestern Ontario Regional Cancer Centre, Thunder Bay, Ontario, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
McGill University, Department of Oncology, Montreal, Quebec, Canada
Arkhangelsk Regional Oncology Center, Department of Chemotherapy, Arkhangelsk, , Russian Federation
Tatarstan Republican Clinical Oncology Center, Kazan, , Russian Federation
Krasnodar Regional Clinical Oncology Center, Chemotherapy Department, Krasnodar, , Russian Federation
Leningrad Regional Oncology Center, Leningrad, , Russian Federation
Lipetsk Regional Oncology Center, Department of General Oncology, Lipetsk, , Russian Federation
Blokhin Cancer Research Center, Department of Chemotherapy and Combined Treatment of Tumors, Moscow, , Russian Federation
Blokhin Cancer Research Center, Department of Chemotherapy, Moscow, , Russian Federation
Blokhin Cancer Research Center, Department of Clinical Pharmacology and Chemotherapy, Moscow, , Russian Federation
Blokhin Cancer Research Center, Department of New Antitumor Drug Research, Moscow, , Russian Federation
Hertzen Research Institute of Oncology, Department of Chemotherapy, Moscow, , Russian Federation
Central Clinical Hospital of the Ministry of Transport n.a. Semashko, Department of Chemotherapy, Moscow, , Russian Federation
Moscow City Hospital #40, Department of Chemotherapy, Moscow, , Russian Federation
Moscow City Oncology Hospital #62, Moscow, , Russian Federation
Murmansk Regional Oncology Center, Murmansk, , Russian Federation
Municipal Clinical Hospital #1, Department of Breast Tumors, Oncology Department, Novosibirsk, , Russian Federation
Medical Radiological Research Center, Obninsk, , Russian Federation
Ryazan Regional Clinical Oncology Center, Ryazan, , Russian Federation
Samara Regional Oncology Center, Department of Chemotherapy, Samara, , Russian Federation
St. Petersburg City Oncology Center, St. Petersburg, , Russian Federation
Laboratory of Thoracic Oncology, St. Petersburg Pavlov State Medical University, Research Institute of Pulmonology, St. Petersburg, , Russian Federation
Petrov Research Institute of Oncology, Department of Biotherapy and Bone Marrow Transplantation, St. Petersburg, , Russian Federation
Petrov Research Institute of Oncology, Department of Breast Cancer, St. Petersburg, , Russian Federation
Petrov Research Institute of Oncology, Department of Chemotherapy, St. Petersburg, , Russian Federation
Stavropol Regional Oncology Center, Department of Chemotherapy, Stavropol, , Russian Federation
Research Institute of Oncology, Tomsk Scientific Center, Siberian Department of the Russian Academy of Medical Sciences, Department of Chemotherapy, Tomsk, , Russian Federation
V. Novgorod Regional Oncology Center, Department of Chemotherapy, V. Novgorod, , Russian Federation
Burdenko Voronezh Medical Academy, Oncology Department, Clinical Facility: Regional Clinical Oncology Center, Voronezh, , Russian Federation
Cherkassy Regional Oncology Center, Chemotherapy Department, Cherkassy, , Ukraine
Dnepropetrovsk State Medical Academy, Oncology Department. Clinical Facility: Dnepropetrovsk City Clinical Hospital #4, Dnepropetrovsk, , Ukraine
Donetsk State Medical University. Clinical Facility: Donetsk Regional Antineoplastic Center, Mammology Department, Donetsk, , Ukraine
Ivano-Frankovsk State Medical Academy; Oncology Department Clinical Facility: Ivano-Frankovsk Regional Oncology Center, Ivano-Frankovsk, , Ukraine
Kharkov State Medical University. Clinical Facility: Grigoriev Medical Radiology Institute, Chemotherapy Department, Kharkov, , Ukraine
Kharkov Medical Academy of Postgraduate Education, Oncology and Pediatric Oncology Department. Clinical Facility: Kharkov Regional Clinical Oncology Dispensary, Chemotherapy Department, Kharkov, , Ukraine
Kiev Central Clinical Hospital, Ukraine Security Services, Surgery Department, Kiev, , Ukraine
Kiev Oncology Institute, Ukraine Medical Science Academy, Department of Breast Tumors, Kiev, , Ukraine
Kiev Postgraduate Studies Medical Academy. Clinical Facility: Kiev City Oncology Hospital, Chemotherapy Department, Kiev, , Ukraine
National Medical University, Oncology Department. Clinical Facility: Kiev City Oncology Hospital, Surgery Department, Kiev, , Ukraine
Krivoy Rog City Oncology Center, Krivoy Rog, , Ukraine
Lviv State Medical University, Oncology and Medical Radiology Department. Clinical Facility: Lviv State Oncology Regional Clinical Diagnostic Center, Chemotherapy Department, Lviv, , Ukraine
Odessa State Medical University, Oncology Department. Clinical Facility: Odessa Regional Oncology Center, Chemotherapy Department, Odessa, , Ukraine
Uzhgorod National University Oncology Course of Surgery Department of Postgraduate Education Faculty Clinical Facility: Zakarpatye Regional Oncology Center, Uzhgorod, , Ukraine
Zaporozhye Statue Institute of Postgraduate Training. Oncology Department; Clinical Facility: Zaporozhye Regional Oncology Center, Zaporozhye, , Ukraine
Contact Details
Name: Paul Goss, M.D.
Affiliation: Princess Margaret Hospital, Canada
Role: STUDY_CHAIR
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