Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Carcinoma

Breast Neoplasms

Recurrence

Carcinoma, Lobular

Carcinoma, Ductal, Breast

Neoplasms, Hormone-Dependent

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Antineoplastic Agents

Bone Density Conservation Agents

Hormones

Letrozole

Estrogens

Estrogen Receptor Modulators

Aromatase Inhibitors

Toremifene

Atamestane

Estrogen Antagonists

Estrogen Receptor Antagonists

Selective Estrogen Receptor Modulators

Hormone Antagonists

Enzyme Inhibitors

Antineoplastic Agents, Hormonal

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

Intarcia Therapeutics

Exemestane

exemestane

adjuvant therapy

aromatase inhibition

conventional surgery

endocrine therapy

hormone therapy

neoadjuvant therapy

surgery

William John Gradishar, MD

RATIONALE: Estrogen and progesterone can stimulate the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by reducing the production of estrogen and progesterone. Giving hormone therapy before surgery may shrink the tumor so it can be removed with breast-conserving surgery. Giving hormone therapy after surgery may kill any remaining tumor cells.

PURPOSE: Phase II trial to study the effectiveness of neoadjuvant and adjuvant exemestane in treating postmenopausal women who have locally advancedestrogen and/or progesterone receptor-positive breast cancer.

OBJECTIVES:

Primary

* Determine the clinical response rate in postmenopausal women with locally advanced hormone receptor-positive breast cancer treated with neoadjuvant and adjuvant exemestane.

Secondary

* Determine the response rate by mammography, ultrasound, MRI, and positron emission tomography scan in patients treated with this drug.
* Determine the time to progression in patients treated with this drug.
* Compare the expression of hormone receptors and epidermal growth factor receptors (including HER2/neu) in patients prior to and after treatment with this drug and correlate these results with clinical response rates.

OUTLINE: Patients receive oral exemestane once daily for 16 weeks in the absence of disease progression or unacceptable toxicity. After 16 weeks, patients undergo surgery and then continue exemestane once daily for a total of 5 years (including the 16 weeks before surgery).

Patients are followed every 3 months for 2 years after surgery and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 16-46 patients will be accrued for this study within 2 years.

Neoadjuvant and Adjuvant Exemestane in Treating Postmenopausal Women With Locally Advanced Hormone Receptor-Positive Breast Cancer

Phase II Study of Neoadjuvant and Adjuvant Exemestane in Postmenopausal Women With Locally Advanced Hormone Receptor-Positive Breast Cancer

National Cancer Institute (NCI)

Robert H. Lurie Cancer Center

atamestane

toremifene

letrozole

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
Neoadjuvant and Adjuvant Exemestane in Treating Postmenopausal Women With Locally Advanced Hormone Receptor-Positive Breast Cancer	NCT00080613	Stage II Breast... Stage IIIA Brea... Stage IIIB Brea... Stage IIIC Brea...	exemestane adjuvant therap... aromatase inhib... conventional su... endocrine thera... hormone therapy neoadjuvant the... surgery	-	National Cancer Institute (NCI)
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

Spots Global Cancer Trial Database for aromatase inhibition