Toremifene With or Without Atamestane in Treating Postmenopausal Women With Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00010322|
Recruitment Status : Terminated (Withdrawn due to change in standard of care - new protocol required)
First Posted : May 5, 2004
Last Update Posted : March 26, 2014
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Toremifene may fight breast cancer by blocking the uptake of estrogen by the tumor cells. Atamestane may fight breast cancer by blocking the production of estrogen. It is not yet known if toremifene is more effective with or without atamestane.
PURPOSE: Randomized phase III trial to compare the effectiveness of toremifene with or without atamestane in treating postmenopausal women who have metastatic breast cancer.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: atamestane Drug: toremifene||Phase 3|
OBJECTIVES: I. Compare the time to progression in postmenopausal women with metastatic breast cancer treated with toremifene with or without atamestane. II. Compare the response rate, overall survival, duration of response, and time to treatment failure in patients treated with these regimens. III. Compare the safety profile of these regimens in this patient population.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to study center. Patients are randomized to one of two treatment arms. Arm I: Patients receive oral toremifene daily and oral atamestane twice daily. Arm II: Patients receive oral toremifene as in arm I and an oral placebo twice daily. Treatment continues for 12-30 months in the absence of disease progression or unacceptable toxicity. Patients are followed every 12 weeks for survival.
PROJECTED ACCRUAL: A total of 594 patients (297 per treatment arm) will be accrued for this study within 18 months.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase III Study of Atamestane Plus Toremifene in Metastatic Breast Cancer|
|Study Start Date :||October 2000|
|Actual Primary Completion Date :||May 2001|
|Actual Study Completion Date :||May 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00010322
|United States, New York|
|Purchase, New York, United States, 10577|
|Study Chair:||Peter Langecker, MD, PhD||Intarcia Therapeutics|