Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Recurrence

Breast Diseases

Skin Diseases

Bone Density Conservation Agents

Antineoplastic Agents

All Drugs and Chemicals

Toremifene

Atamestane

Antineoplastic Agents, Hormonal

Estrogens

Estrogen Receptor Modulators

Selective Estrogen Receptor Modulators

Hormones

Hormone Antagonists

Enzyme Inhibitors

atamestane

toremifene

Peter Langecker, MD, PhD

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.

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.

Toremifene With or Without Atamestane in Treating Postmenopausal Women With Metastatic Breast Cancer

Phase III Study of Atamestane Plus Toremifene in Metastatic Breast Cancer

Intarcia Therapeutics

Carcinoma

Carcinoma, Lobular

Carcinoma, Ductal, Breast

Neoplasms, Hormone-Dependent

Letrozole

Aromatase Inhibitors

Estrogen Antagonists

Estrogen Receptor Antagonists

Aromatase inhibition

Estrogen receptor blocker

Hormone therapy

Endocrine therapy

Antiestrogen therapy

Edith Perez, MD

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.

Aromatase is an enzyme expressed in tissues such as muscle and fat in postmenopausal women. These non-ovarian tissues become the dominant sources of estrogen in postmenopausal women. Breast cancer cells are often very dependent on estrogens to continue to grow. Atamestane blocks the formation of estrogens from androgenic precursors in the body via the aromatase enzyme. Toremifene blocks circulating and intracellular estrogens from stimulating estrogen receptors in breast cancer cells. The goal of therapy with atamestane, an aromatase inhibitor, in combination with the estrogen receptor antagonist, toremifene, is to achieve complete suppression of estrogen stimulation of breast cancer cells. This study is designed to determine whether combined hormonal therapy will lengthen the time to disease progression and the rate of objective response, as compared to single agent therapy with the approved aromatase inhibitor letrozole.

The CAT Study: Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer

Phase 3 Study of Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer

letrozole

aromatase inhibition

hormone therapy

endocrine therapy

antiestrogen therapy

Paul Goss, M.D.

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.

Breast cancer cells are often very dependent on estrogens to continue to grow. Atamestane blocks the formation of estrogens and androgenic precursors in the body. Toremifene blocks circulating and intracellular estrogens from stimulating estrogen receptors in breast cancer cells. The goal of therapy with atamestane, an aromatase inhibitor, in combination with the estrogen receptor antagonist, toremifene, is to achieve maximal suppression of estrogen stimulation of breast cancer cells. This study is designed to determine whether combination therapy will lengthen the time to disease progression and the rate of objective response compared to single agent aromatase inhibitor therapy with letrozole.

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

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.

Aromatase is an enzyme expressed in tissues such as muscle and fat in postmenopausal women. These non-ovarian tissues become the dominant sources of estrogen in postmenopausal women. Breast cancer cells are often very dependent on estrogens to continue to grow. Atamestane blocks the formation of estrogens from androgenic precursors in the body via the aromatase enzyme. Toremifene blocks circulating and intracellular estrogens from stimulating estrogen receptors in breast cancer cells. The goal of therapy with atamestane, an aromatase inhibitor, in combination with the estrogen receptor antagonist, toremifene, is to achieve complete suppression of estrogen stimulation of breast cancer cells. This study is designed to determine whether combined hormonal therapy will lengthen the time to disease progression and the survival time for subjects with advanced breast cancer.

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

Open Label Treatment and Survival Continuation Study of Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Toremifene With or Without Atamestane in Treating Postmenopausal Women With Metastatic Breast Cancer	NCT00010322	Breast Cancer	atamestane toremifene	18 Years -	Intarcia Therapeutics
The CAT Study: Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer	NCT00097344	Breast Neoplasm... Neoplasms, Horm...	Atamestane Toremifene Letrozole Aromatase inhib... Estrogen recept... Hormone therapy Endocrine thera... Antiestrogen th...	18 Years -	Intarcia Therapeutics
Toremifene With or Without Atamestane in Treating Postmenopausal Women With Metastatic Breast Cancer	NCT00010322	Breast Cancer	atamestane toremifene	18 Years -	Intarcia Therapeutics
Toremifene With or Without Atamestane in Treating Postmenopausal Women With Metastatic Breast Cancer	NCT00010322	Breast Cancer	atamestane toremifene	18 Years -	Intarcia Therapeutics
The CAT Study: Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer	NCT00097344	Breast Neoplasm... Neoplasms, Horm...	Atamestane Toremifene Letrozole Aromatase inhib... Estrogen recept... Hormone therapy Endocrine thera... Antiestrogen th...	18 Years -	Intarcia Therapeutics
Phase III Study of Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer	NCT00044291	Breast Neoplasm... Neoplasms, Horm...	atamestane toremifene letrozole aromatase inhib... hormone therapy endocrine thera... antiestrogen th...	18 Years -	Intarcia Therapeutics
Treatment and Survival Continuation Study of Atamestane Plus Toremifene vs Letrozole in Advanced Breast Cancer	NCT00267553	Breast Neoplasm... Neoplasms, Horm...	Atamestane toremifene letrozole	18 Years -	Intarcia Therapeutics

Spots Global Cancer Trial Database for atamestane

Every month we try and update this database with for atamestane cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for atamestane

Every month we try and update this database with for atamestane cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for atamestane cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.