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Phase III Study of Atamestane Plus Toremifene versus Letrozole in Advanced Breast Cancer Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Phase III Study of Atamestane Plus Toremifene versus Letrozole in Advanced Breast Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Phase III Study of Atamestane Plus Toremifene versus Letrozole in Advanced Breast Cancer Clinical research trials and Phase III Study of Atamestane Plus Toremifene versus Letrozole in Advanced Breast Cancer health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Phase III Study of Atamestane Plus Toremifene versus Letrozole in Advanced Breast Cancer. Phase III Study of Atamestane Plus Toremifene versus Letrozole in Advanced Breast Cancer Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Phase III Study of Atamestane Plus Toremifene versus Letrozole in Advanced Breast Cancer clinical trial. Human subjects often get the best healthcare available for their Phase III Study of Atamestane Plus Toremifene versus Letrozole in Advanced Breast Cancer condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Phase III Study of Atamestane Plus Toremifene versus Letrozole in Advanced Breast Cancer  Phase III Study of Atamestane Plus Toremifene versus Letrozole in Advanced Breast Cancer
Phase III Study of Atamestane Plus Toremifene versus Letrozole in Advanced Breast Cancer
For Condition: Neoplasms, Hormone-Dependent,Breast Neoplasms
Status: Recruiting
Sponsor(s): BioMedicines ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Female
Protocol Entry Criteria: Inclusion Criteria: - Women age 18 years or older - Pathological or histological confirmation of breast cancer at initial diagnosis or at the time of metastases - ECOG performance status of 0, 1 or 2 or Karnofsky performance status of 60 or higher - Predicted life expectancy of 12 weeks or more - Postmenopausal endocrine status. LH/FSH levels in the postmenopausal range in women whose menopause occurred less than 5 years ago - Locally recurrent, locally advanced, locally metastatic disease not amenable to radiation therapy or surgery and/or distant metastatic disease - At least one tumor localization measurable in 2 dimensions (one diameter at least 2 cm for soft tissue/visceral disease assessed by CT/MRI scan or conventional X-ray technique, one diameter at least 1 cm for bone lesions assessed by conventional X-ray techniques) - Estrogen receptor and/or progesterone receptor positive (by laboratory/institutional standard) at the time of initial diagnosis or determined during subsequent biopsy/surgery of metastases - Written informed consent obtained Exclusion Criteria: - Prior hormonal therapy to treat locally recurrent, locally advanced or metastatic disease - Prior adjuvant therapy with aromatase inhibitors or antiestrogens/SERMs within 12 months prior to enrollment - Progression of disease during therapy with antiestrogens (including SERMs administered for prevention of osteoporosis) - Life-threatening locally recurrent, locally advanced or metastatic disease or disease requiring chemotherapeutic intervention (such as inflammatory breast cancer) - History of known CNS metastases, significant neurological dysfunction including active seizures, or clinical signs of other significant neurological diseases - Other active malignancy (except basal cell carcinoma of the skin or in situ cervical cancer). Patients with previous malignancies must be without evidence of disease for at least five years - Renal insufficiency (serum creatinine > 2.0 mg/dL) - Aspartate aminotransferase, alanine aminotransferase or serum bilirubin levels more than 2.5 times upper limit of normal - Hemoglobin <9 g/dL - Platelet count of less than 100,000 platelets per mm3 - Total white blood cell count of less than 2,000 cells per mm3 - Premenopausal endocrine status; pregnant or lactating females - Usage of an investigational drug within the thirty (30) days prior to enrollment; or the planned usage of an investigational drug other than the study medication during the course of the current study - Contraindication to use of toremifene, atamestane, letrozole or any of the inactive components of their formulations - Prior enrollment in this study
Total Enrollment: 842
Location and Contact Information:
Overall Study Official:
PaulGoss, Study Chair, Princess Margaret Hospital
Petrov Research Institute of Oncology, Department of Chemotherapy *Recruiting*
St Petersburg, , 197758
Russian Federation
Recruiting Mikhail Gershanovich +7-812-596-89-39
Lviv State Medical University, Oncology and Medical Radiology Department. Clinical Facility: Lviv State Oncology Regional Clinical Diagnostic Center, Chemotherapy Department *Recruiting*
Lviv, , 79031
Ukraine
Recruiting Boris Bilynskiy +380 (322) 23 14 82
Arkhangelsk Regional Oncology Center, Department of Chemotherapy *Recruiting*
Arkhangelsk, , 163045
Russian Federation
Recruiting Olga Vtoraya +7-8182-27-64-63
Petrov Research Institute of Oncology, Department of Breast Cancer *Recruiting*
St Petersburg, , 197758
Russian Federation
Recruiting Vladimir Semiglazov +7-812-596-89-18
Kharkov State Medical University. Clinical Facility: Grigoriev Medical Radiology Institute, Chemotherapy Department *Recruiting*
Kharkov, , 61024
Ukraine
Recruiting Nickolay Pilipenko +380 (572) 43 11 25
Hematology-Oncology of Indiana, PC *Recruiting*
Indianapolis, Indiana, 46260
United States
Recruiting Patti Wolf 317-415-6631
Moscow Clinical Oncology Center *Terminated*
Moscow, , 107005
Russian Federation
Terminated
Blokhin Cancer Research Center, Department of Chemotherapy *Recruiting*
Moscow, , 115478
Russian Federation
Recruiting Vera Gorbunova +7-095-324-94-29
Hematology Oncology Consultants, Inc. *Recruiting*
Columbus, Ohio, 43235
United States
Recruiting Frank McKim 614-846-0044
McGill University, Department of Oncology *Recruiting*
Montreal, Quebec, H2W1S6
Canada
Recruiting Penny Chipman
Kiev Central Clinical Hospital, Ukraine Security Services, Surgery Department *Terminated*
Kiev, , 01021
Ukraine
Terminated
Northwestern Ontario Regional Cancer Centre *Recruiting*
Thunder Bay, Ontario, P7A7T1
Canada
Recruiting Kay Cranston 807-343-1560
Kharkov Medical Academy of Postgraduate Education, Oncology and Pediatric Oncology Department. Clinical Facility: Kharkov Regional Clinical Oncology Dispensary, Chemotherapy Department *Recruiting*
Kharkov, , 61070
Ukraine
Recruiting Alexander Dudnichenko 10-380-572-44-11-75
Kansas City Oncology and Hematology Group *Recruiting*
Kansas City, Missouri, 64131
United States
Recruiting Vickie Thomas 913-541-4641
Oncology Consultants *Recruiting*
Houston, Texas, 77024
United States
Recruiting Susan Feliciano 713-827-7062
Hertzen Research Institute of Oncology, Department of Chemotherapy *Recruiting*
Moscow, , 125284
Russian Federation
Recruiting Larisa Bolotina +7 (095) 945 88 16
Stavropol Regional Oncology Center, Department of Chemotherapy *Recruiting*
Stavropol, , 355018
Russian Federation
Recruiting Sergey Mikhailov +7-8652-38-36-76
Ryazan Regional Clinical Oncology Center *Recruiting*
Ryazan, , 390046
Russian Federation
Recruiting Marina Shomova +7-0912-45-66-11
Cooper Cancer Institute *Terminated*
Voorhees, New Jersey, 08043
United States
Terminated
Oncology-Hematology Associates of Southwest Virginia *Terminated*
Salem, Virginia, 24153
United States
Terminated
Upstate NY Cancer Research & Education Foundation *Terminated*
Rochester, New York, 14623
United States
Terminated
Integre se lutte contre le cancer de la Monteregic *Not yet recruiting*
Greenfield Park, Quebec, J4V 2H1
Canada
Not yet recruiting Francine Richard 450-466-5000
Princess Margaret Hospital *Recruiting*
Toronto, Ontario, M5G 2M9
Canada
Recruiting Heidi Gotthardt 416-946-2269
Blokhin Cancer Research Center, Department of Chemotherapy and Combined Treatment of Tumors *Recruiting*
Moscow, , 115478
Russian Federation
Recruiting Mikhail Lichinitser +7-095-324-18-90
Central Clinical Hospital of the Ministry of Transport n.a. Semashko, Department of Chemotherapy *Recruiting*
Moscow, , 129128
Russian Federation
Recruiting Mikhail Byakhov +7-095-187-74-83
Krasnodar Regional Clinical Oncology Center, Chemotherapy Department *Recruiting*
Krasnodar, , 350040
Russian Federation
Recruiting Irina Mitashok +7-8612-33-77-67
Virginia Oncology Associates *Recruiting*
Norfolk, Virginia, 23502
United States
Recruiting Anita Hailey 757-459-9226
Blokhin Cancer Research Center, Department of New Antitumor Drug Research *Recruiting*
Moscow, , 115478
Russian Federation
Recruiting Lyudmila Manzyuk +7-095-324-25-74
Research Institute of Oncology, Tomsk Scientific Center, Siberian Department of the Russian Academy of Medical Sciences, Department of Chemotherapy *Recruiting*
Tomsk, , 634028
Russian Federation
Recruiting Viktor Goldberg +7-3822-41-80-86
Oncology Care Associates, PLLC *Recruiting*
St. Joseph, Michigan, 49085
United States
Recruiting Eric Lester 269-985-0029
Mount Sinai Comprehensive Cancer Center *No longer recruiting*
Miami, Florida, 33140
United States
No longer recruiting
City Clinical Hospital #40, Oncomammology Department *Terminated*
Ekaterinburg, , 620102
Russian Federation
Terminated
Burdenko Voronezh Medical Academy, Oncology Department, Clinical Facility: Regional Clinical Oncology Center *Recruiting*
Voronezh, , 394000
Russian Federation
Recruiting Nickolay Ognerubov +7 (0732) 53 31 99
Ottawa Regional Cancer Centre *Recruiting*
Ottawa, Ontario, K 1H 1C4
Canada
Recruiting Julie Wells 613-737-7700
Western Washington Oncology Inc., P.S. *Recruiting*
Olympia, Washington, 98502
United States
Recruiting Billie Smith 360-754-3934
Blokhin Cancer Research Center, Department of Clinical Pharmacology and Chemotherapy *Recruiting*
Moscow, , 115478
Russian Federation
Recruiting Sergey Tjulandin +7-095-324-98-44
Medical Radiological Research Center *Recruiting*
Obninsk, , 249036
Russian Federation
Recruiting Iya Smirnova +7-08439-72-733
Dnepropetrovsk State Medical Academy, Oncology Department. Clinical Facility: Dnepropetrovsk City Clinical Hospital #4 *Recruiting*
Dnepropetrovsk, , 49102
Ukraine
Recruiting Igor Bondarenko 10-380-562-58-53-72
Donetsk State Medical University. Clinical Facility: Donetsk Regional Antineoplastic Center, Mammology Department *Recruiting*
Donetsk, , 83092
Ukraine
Recruiting Alexander Popovich +380 (622) 23 98 00
State Institution Municipal Clinical Hospital #33 n.a. A.A. Ostroumov, Chemotherapy Department *Recruiting*
Moscow, , 107014
Russian Federation
Recruiting Gennady Varlan +7-095-268-23-85
Petrov Research Institute of Oncology, Department of Biotherapy and Bone Marrow Transplantation *Recruiting*
St Petersburg, , 197758
Russian Federation
Recruiting Vladimir Moiseyenko +7-812-596-89-39
Samara Regional Oncology Center, Department of Chemotherapy *Recruiting*
Samara, , 443066
Russian Federation
Recruiting Mikhail Kopp +7-8462-242-885
Municipal Clinical Hospital #1, Department of Breast Tumors, Oncology Department *Recruiting*
Novosibirsk, , 630047
Russian Federation
Recruiting Sergey Sidorov +7-3832-25-16-53
N. Novgorod City Oncology Center, Department of Chemotherapy *Not yet recruiting*
N. Novgorod, , 603000
Russian Federation
Not yet recruiting Irina Koroleva +7-8312-64-53-98
St. Petersburg City Oncology Center *Recruiting*
St Petersburg, , 197022
Russian Federation
Recruiting Georgiy Manikhas +7-812-234-37-22
Kiev Oncology Institute, Ukraine Medical Science Academy, Department of Breast Tumors *Recruiting*
Kiev, , 03022
Ukraine
Recruiting Olga Lygyrda +380 (44) 263 10 52
Kiev Postgraduate Studies Medical Academy. Clinical Facility: Kiev City Oncology Hospital, Chemotherapy Department *Recruiting*
Kiev, , 03115
Ukraine
Recruiting Dmitriy Myasoyedov +380 (44) 450 74 35
Odessa State Medical University, Oncology Department. Clinical Facility: Odessa Regional Oncology Center, Chemotherapy Department *Recruiting*
Odessa, , 65055
Ukraine
Recruiting Vilen Stepula +380 (48) 223 43 87
California Cancer Care, Inc. *Recruiting*
Greenbrae, California, 94904-2007
United States
Recruiting Jaime Chang 415-925-5040
The Cancer Center *Terminated*
Mobile, Alabama, 36608
United States
Terminated
Maryland Hematology/Oncology Associates *Recruiting*
Baltimore, Maryland, 21236
United States
Recruiting Vicki D'Angelo 410-687-5300
V. Novgorod Regional Oncology Center, Department of Chemotherapy *Recruiting*
V. Novgorod, , 173016
Russian Federation
Recruiting Vladimir Ivanchenko +7-81622-27-042
National Medical University, Oncology Department. Clinical Facility: Kiev City Oncology Hospital, Surgery Department *Recruiting*
Kiev, , 03115
Ukraine
Recruiting Valeriy Cheshuk +380-44-450-82-32
Additional Information:
Study ID Numbers: Biomed 777-CLP-29;
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00044291
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Phase III Study of Atamestane Plus Toremifene versus Letrozole in Advanced Breast Cancer
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