Phase III Study of Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer

Completed · Phase 3 · Has a placebo group

Conditions studied: Breast Neoplasms, Neoplasms, Hormone-dependent

In brief

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.

Key facts

Study ID

NCT00044291

Run by

Intarcia Therapeutics

People needed

865

Starts

2002-06-01

Expected to finish

2006-01-01

Last updated by the study team

2015-07-31

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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

Where it is running

• 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 — Saint 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, Russia
• Tatarstan Republican Clinical Oncology Center — Kazan', Russia
• Krasnodar Regional Clinical Oncology Center, Chemotherapy Department — Krasnodar, Russia
• Lipetsk Regional Oncology Center, Department of General Oncology — Lipetsk, Russia
• Midwest Internal Medicine, PLLC — Lake Havasu City, Arizona, United States

Full record on ClinicalTrials.gov

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