Phase III Study of Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer
1 other identifier
interventional
865
4 countries
63
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2002
Typical duration for phase_3
63 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2002
CompletedFirst Submitted
Initial submission to the registry
August 23, 2002
CompletedFirst Posted
Study publicly available on registry
August 27, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2006
CompletedJuly 31, 2015
July 1, 2015
3.6 years
August 23, 2002
July 29, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to tumor progression
time from randomization to first occurrence of tumor progression, assessed at week 12 and every subsequent 12 weeks for patients continuing in the study for up to approximately 36 months
Study Arms (2)
Atamestane + toremifene
EXPERIMENTALLetrozole + placebo
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (63)
Midwest Internal Medicine, PLLC
Lake Havasu City, Arizona, 86403, United States
Arizona Clinical Research Center
Tucson, Arizona, 85712, United States
California Cancer Care, Inc.
Greenbrae, California, 94904-2007, United States
Sharp Memorial Hospital
San Diego, California, 92123, United States
Innovative Medical Research of South Florida Inc.
Miami Shores, Florida, 33138, United States
Georgia Cancer Specialists
Tucker, Georgia, 30084, United States
Maryland Hematology/Oncology Associates
Baltimore, Maryland, 21236, United States
Oncology Care Associates, PLLC
Saint Joseph, Michigan, 49085, United States
Kansas City Oncology and Hematology Group
Kansas City, Missouri, 64131, United States
Great Falls Clinic-Oncology West
Great Falls, Montana, 59405, United States
Slocum-Dickson Medical Group
New Hartford, New York, 13413, United States
Hematology Oncology Consultants, Inc.
Columbus, Ohio, 43235, United States
Oncology Consultants
Houston, Texas, 77024, United States
First Dynamic Healthcare Services, Inc.
Killeen, Texas, 76710, United States
Cache Valley Cancer Treatment & Research Clinic
Logan, Utah, 84341, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Western Washington Oncology Inc., P.S.
Olympia, Washington, 98502, United States
Ottawa Regional Cancer Centre
Ottawa, Ontario, K 1H 1C4, Canada
Northwestern Ontario Regional Cancer Centre
Thunder Bay, Ontario, P7A7T1, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
McGill University, Department of Oncology
Montreal, Quebec, H2W1S6, Canada
Arkhangelsk Regional Oncology Center, Department of Chemotherapy
Arkhangelsk, 163045, Russia
Tatarstan Republican Clinical Oncology Center
Kazan', 420029, Russia
Krasnodar Regional Clinical Oncology Center, Chemotherapy Department
Krasnodar, 350040, Russia
Lipetsk Regional Oncology Center, Department of General Oncology
Lipetsk, 398005, Russia
Blokhin Cancer Research Center, Department of Chemotherapy and Combined Treatment of Tumors
Moscow, 115478, Russia
Blokhin Cancer Research Center, Department of Chemotherapy
Moscow, 115478, Russia
Blokhin Cancer Research Center, Department of Clinical Pharmacology and Chemotherapy
Moscow, 115478, Russia
Blokhin Cancer Research Center, Department of New Antitumor Drug Research
Moscow, 115478, Russia
Hertzen Research Institute of Oncology, Department of Chemotherapy
Moscow, 125284, Russia
Central Clinical Hospital of the Ministry of Transport n.a. Semashko, Department of Chemotherapy
Moscow, 129128, Russia
Moscow City Hospital #40, Department of Chemotherapy
Moscow, 129301, Russia
Moscow City Oncology Hospital #62
Moscow, 143423, Russia
Murmansk Regional Oncology Center
Murmansk, 183047, Russia
Municipal Clinical Hospital #1, Department of Breast Tumors, Oncology Department
Novosibirsk, 630047, Russia
Medical Radiological Research Center
Obninsk, 249036, Russia
Ryazan Regional Clinical Oncology Center
Ryazan, 390046, Russia
Leningrad Regional Oncology Center
Saint Petersburg, 188663, Russia
St. Petersburg City Oncology Center
Saint Petersburg, 197022, Russia
Laboratory of Thoracic Oncology, St. Petersburg Pavlov State Medical University, Research Institute of Pulmonology
Saint Petersburg, 197089, Russia
Petrov Research Institute of Oncology, Department of Biotherapy and Bone Marrow Transplantation
Saint Petersburg, 197758, Russia
Petrov Research Institute of Oncology, Department of Breast Cancer
Saint Petersburg, 197758, Russia
Petrov Research Institute of Oncology, Department of Chemotherapy
Saint Petersburg, 197758, Russia
Samara Regional Oncology Center, Department of Chemotherapy
Samara, 443066, Russia
Stavropol Regional Oncology Center, Department of Chemotherapy
Stavropol, 355018, Russia
Research Institute of Oncology, Tomsk Scientific Center, Siberian Department of the Russian Academy of Medical Sciences, Department of Chemotherapy
Tomsk, 634028, Russia
V. Novgorod Regional Oncology Center, Department of Chemotherapy
V. Novgorod, 173016, Russia
Burdenko Voronezh Medical Academy, Oncology Department, Clinical Facility: Regional Clinical Oncology Center
Voronezh, 394000, Russia
Cherkassy Regional Oncology Center, Chemotherapy Department
Cherkassy, 18009, Ukraine
Dnepropetrovsk State Medical Academy, Oncology Department. Clinical Facility: Dnepropetrovsk City Clinical Hospital #4
Dnipro, 49102, Ukraine
Donetsk State Medical University. Clinical Facility: Donetsk Regional Antineoplastic Center, Mammology Department
Donetsk, 83092, Ukraine
Ivano-Frankovsk State Medical Academy; Oncology Department Clinical Facility: Ivano-Frankovsk Regional Oncology Center
Ivano-Frankivsk, 76000, Ukraine
Kharkov State Medical University. Clinical Facility: Grigoriev Medical Radiology Institute, Chemotherapy Department
Kharkiv, 61024, Ukraine
Kharkov Medical Academy of Postgraduate Education, Oncology and Pediatric Oncology Department. Clinical Facility: Kharkov Regional Clinical Oncology Dispensary, Chemotherapy Department
Kharkiv, 61070, Ukraine
Kiev Central Clinical Hospital, Ukraine Security Services, Surgery Department
Kiev, 01021, Ukraine
Kiev Oncology Institute, Ukraine Medical Science Academy, Department of Breast Tumors
Kiev, 03022, Ukraine
Kiev Postgraduate Studies Medical Academy. Clinical Facility: Kiev City Oncology Hospital, Chemotherapy Department
Kiev, 03115, Ukraine
National Medical University, Oncology Department. Clinical Facility: Kiev City Oncology Hospital, Surgery Department
Kiev, 03115, Ukraine
Krivoy Rog City Oncology Center
Kryvyi Rih, 50048, Ukraine
Lviv State Medical University, Oncology and Medical Radiology Department. Clinical Facility: Lviv State Oncology Regional Clinical Diagnostic Center, Chemotherapy Department
Lviv, 79031, Ukraine
Odessa State Medical University, Oncology Department. Clinical Facility: Odessa Regional Oncology Center, Chemotherapy Department
Odesa, 65055, Ukraine
Uzhgorod National University Oncology Course of Surgery Department of Postgraduate Education Faculty Clinical Facility: Zakarpatye Regional Oncology Center
Uzhhorod, 88000, Ukraine
Zaporozhye Statue Institute of Postgraduate Training. Oncology Department; Clinical Facility: Zaporozhye Regional Oncology Center
Zaporizhzhya, 69104, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Paul Goss, M.D.
Princess Margaret Hospital, Canada
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2002
First Posted
August 27, 2002
Study Start
June 1, 2002
Primary Completion
January 1, 2006
Study Completion
January 1, 2006
Last Updated
July 31, 2015
Record last verified: 2015-07