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

NCT ID: NCT00267553

Last Updated: 2007-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2006-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Neoplasms Neoplasms, Hormone-Dependent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Atamestane

Intervention Type DRUG

toremifene

Intervention Type DRUG

letrozole

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* To be eligible to receive continued treatment, subjects must remain eligible to receive study drug at the time of their last Biomed 777-CLP-29 visit
* To continue on survival follow-up, subjects must be in survival follow-up in study Biomed 777-CLP-29
* Written informed consent obtained for subjects who continue study drug treatment

Exclusion Criteria

* Subjects who have withdrawn consent to participate in Biomed 777-CLP-29 for any reason
* Subjects for whom the investigator considers study participation is no longer in the best interest of those subjects.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Intarcia Therapeutics

INDUSTRY

Sponsor Role lead

Principal Investigators

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Peter Langecker, MD, PhD

Role: STUDY_DIRECTOR

Intarcia Therapeutics

Locations

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Greenbrae, California, United States

Site Status

Saint Joseph, Michigan, United States

Site Status

Kansas City, Missouri, United States

Site Status

Houston, Texas, United States

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Norfolk, Virginia, United States

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Lacey, Washington, United States

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Ottawa, Ontario, Canada

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Thunder Bay, Ontario, Canada

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Montreal, Quebec, Canada

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Arkhangelsk, , Russia

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Kazan', , Russia

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Krasnodar, , Russia

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Leningrad Region, , Russia

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Lipetsk, , Russia

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Moscow, , Russia

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Murmansk, , Russia

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Nizhny Novgorod, , Russia

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Novosibirsk, , Russia

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Obninsk, , Russia

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Ryazan, , Russia

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Saint Petersburg, , Russia

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Samara, , Russia

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Stavropol, , Russia

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Tomsk, , Russia

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Veliky Novgorod, , Russia

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Voronezh, , Russia

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Dnipro, , Ukraine

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Donetsk, , Ukraine

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Ivano-Frankivsk, , Ukraine

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Kharkiv, , Ukraine

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Kiev, , Ukraine

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Kryvyi Rih, , Ukraine

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Lviv, , Ukraine

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Odesa, , Ukraine

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Uzhhorod, , Ukraine

Site Status

Countries

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United States Canada Russia Ukraine

Other Identifiers

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Biomed 777-CLP-32

Identifier Type: -

Identifier Source: org_study_id