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Treatment and Survival Continuation Study of Atamestane Plus Toremifene vs Letrozole in Advanced Breast Cancer

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clinicaltrials.gov/study/NCT00267553
Is a
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Clinical study
0

Clinical Study attributes

NCT Number
NCT002675530
Trial Recruitment Size
2000
Trial Sponsor
Intarcia Therapeutics
Intarcia Therapeutics
0
Clinical Trial Start Date
2005
0
Study Completion Date
2006
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Interventional Trial Phase
Phase 30
Official Name
Open Label Treatment and Survival Continuation Study of Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer0
Last Updated
September 10, 2007
0
Allocation Type
Randomized0
Intervention Model
Parallel Assignment0
Masking Type
Double0
Study summary

Protocol 777-CLP-32 is the treatment and survival continuation protocol of Biomed 777-CLP-29, and will continue to compare combined hormonal therapy using the experimental aromatase inhibitor (AI) atamestane combined with the FDA-approved anti-estrogen toremifene (Fareston®), to the single agent FDA-approved aromatase inhibitor letrozole (Femara®) for the treatment of advanced breast cancer. The purpose of this study is to determine whether maximal estrogen suppression achieved via the combination of atamestane, plus toremifene (Fareston®), is more effective than letrozole (Femara®) in delaying the growth of breast cancer.

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