CLINICAL TRIALS PROFILE FOR ATAMESTANE

Clinical Trials for Atamestane

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00010322 ↗	Toremifene With or Without Atamestane in Treating Postmenopausal Women With Metastatic Breast Cancer	Terminated	Intarcia Therapeutics	Phase 3	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.
NCT00044291 ↗	Phase III Study of Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer	Completed	Intarcia Therapeutics	Phase 3	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.
NCT00097344 ↗	The CAT Study: Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer	Terminated	Intarcia Therapeutics	Phase 3	The purpose of this study is to determine whether maximal estrogen suppression achieved via the combination 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, and whether the side effects of the combined hormonal therapy are different from the side effects of letrozole.
NCT00267553 ↗	Treatment and Survival Continuation Study of Atamestane Plus Toremifene vs Letrozole in Advanced Breast Cancer	Terminated	Intarcia Therapeutics	Phase 3	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.

Clinical Trial Conditions for Atamestane

Condition Name

Condition Name for
Intervention	Trials
Breast Neoplasms	3
Neoplasms, Hormone-dependent	3
Breast Cancer	1

Condition MeSH

Condition MeSH for
Intervention	Trials
Breast Neoplasms	4
Neoplasms, Hormone-Dependent	3
Neoplasms	3

Clinical Trial Locations for Atamestane

Trials by Country

Trials by Country for
Location	Trials
United States	49
Canada	4
Ukraine	3
Russian Federation	3
Romania	1

Trials by US State

Trials by US State for
Location	Trials
New York	3
Virginia	3
Texas	3
Missouri	3
Michigan	3

Clinical Trial Progress for Atamestane

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase	Trials
Phase 3	4

Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase	Trials
Terminated	3
Completed	1

Clinical Trial Sponsors for Atamestane

Sponsor Name

Sponsor Name for
Sponsor	Trials
Intarcia Therapeutics	4

Sponsor Type

Sponsor Type for
Sponsor	Trials
Industry	4