Phase III Study of Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer
Breast Neoplasms, Neoplasms, Hormone-dependent
About this trial
This is an interventional treatment trial for Breast Neoplasms focused on measuring 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
Eligibility 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
Sites / Locations
- Midwest Internal Medicine, PLLC
- Arizona Clinical Research Center
- California Cancer Care, Inc.
- Sharp Memorial Hospital
- Innovative Medical Research of South Florida Inc.
- Georgia Cancer Specialists
- Maryland Hematology/Oncology Associates
- Oncology Care Associates, PLLC
- Kansas City Oncology and Hematology Group
- Great Falls Clinic-Oncology West
- Slocum-Dickson Medical Group
- Hematology Oncology Consultants, Inc.
- Oncology Consultants
- First Dynamic Healthcare Services, Inc.
- Cache Valley Cancer Treatment & Research Clinic
- Virginia Oncology Associates
- Western Washington Oncology Inc., P.S.
- Ottawa Regional Cancer Centre
- Northwestern Ontario Regional Cancer Centre
- Princess Margaret Hospital
- McGill University, Department of Oncology
- Arkhangelsk Regional Oncology Center, Department of Chemotherapy
- Tatarstan Republican Clinical Oncology Center
- Krasnodar Regional Clinical Oncology Center, Chemotherapy Department
- Leningrad Regional Oncology Center
- Lipetsk Regional Oncology Center, Department of General Oncology
- Blokhin Cancer Research Center, Department of Chemotherapy and Combined Treatment of Tumors
- Blokhin Cancer Research Center, Department of Chemotherapy
- Blokhin Cancer Research Center, Department of Clinical Pharmacology and Chemotherapy
- Blokhin Cancer Research Center, Department of New Antitumor Drug Research
- Hertzen Research Institute of Oncology, Department of Chemotherapy
- Central Clinical Hospital of the Ministry of Transport n.a. Semashko, Department of Chemotherapy
- Moscow City Hospital #40, Department of Chemotherapy
- Moscow City Oncology Hospital #62
- Murmansk Regional Oncology Center
- Municipal Clinical Hospital #1, Department of Breast Tumors, Oncology Department
- Medical Radiological Research Center
- Ryazan Regional Clinical Oncology Center
- Samara Regional Oncology Center, Department of Chemotherapy
- St. Petersburg City Oncology Center
- Laboratory of Thoracic Oncology, St. Petersburg Pavlov State Medical University, Research Institute of Pulmonology
- Petrov Research Institute of Oncology, Department of Biotherapy and Bone Marrow Transplantation
- Petrov Research Institute of Oncology, Department of Breast Cancer
- Petrov Research Institute of Oncology, Department of Chemotherapy
- Stavropol Regional Oncology Center, Department of Chemotherapy
- Research Institute of Oncology, Tomsk Scientific Center, Siberian Department of the Russian Academy of Medical Sciences, Department of Chemotherapy
- V. Novgorod Regional Oncology Center, Department of Chemotherapy
- Burdenko Voronezh Medical Academy, Oncology Department, Clinical Facility: Regional Clinical Oncology Center
- Cherkassy Regional Oncology Center, Chemotherapy Department
- Dnepropetrovsk State Medical Academy, Oncology Department. Clinical Facility: Dnepropetrovsk City Clinical Hospital #4
- Donetsk State Medical University. Clinical Facility: Donetsk Regional Antineoplastic Center, Mammology Department
- Ivano-Frankovsk State Medical Academy; Oncology Department Clinical Facility: Ivano-Frankovsk Regional Oncology Center
- Kharkov State Medical University. Clinical Facility: Grigoriev Medical Radiology Institute, Chemotherapy Department
- Kharkov Medical Academy of Postgraduate Education, Oncology and Pediatric Oncology Department. Clinical Facility: Kharkov Regional Clinical Oncology Dispensary, Chemotherapy Department
- Kiev Central Clinical Hospital, Ukraine Security Services, Surgery Department
- Kiev Oncology Institute, Ukraine Medical Science Academy, Department of Breast Tumors
- Kiev Postgraduate Studies Medical Academy. Clinical Facility: Kiev City Oncology Hospital, Chemotherapy Department
- National Medical University, Oncology Department. Clinical Facility: Kiev City Oncology Hospital, Surgery Department
- Krivoy Rog City Oncology Center
- Lviv State Medical University, Oncology and Medical Radiology Department. Clinical Facility: Lviv State Oncology Regional Clinical Diagnostic Center, Chemotherapy Department
- Odessa State Medical University, Oncology Department. Clinical Facility: Odessa Regional Oncology Center, Chemotherapy Department
- Uzhgorod National University Oncology Course of Surgery Department of Postgraduate Education Faculty Clinical Facility: Zakarpatye Regional Oncology Center
- Zaporozhye Statue Institute of Postgraduate Training. Oncology Department; Clinical Facility: Zaporozhye Regional Oncology Center
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Atamestane + toremifene
Letrozole + placebo