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

NCT00267553 | Terminated Phase 3

• 1 other identifier: Biomed 777-CLP-32
• Study Type: interventional
• Target: 200
• Locations: 4 countries
• Sites: 35

Brief 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.

Conditions

Breast Neoplasms; Neoplasms, Hormone-Dependent

Keywords

Atamestane; Breast neoplasms; Combined hormonal therapy; Complete estrogen blockade; Ductal breast carcinoma; Estrogen blocker; Fareston®; Femara®; First line therapy; Letrozole; Lobular breast carcinoma; Locally advanced breast cancer; Locally recurrent breast cancer; Maximal estrogen inhibition; Metastatic breast cancer; Neoplasms, Hormone-dependent; Receptor-positive; Stage IIIA breast cancer; Stage IIIB breast cancer; Stage IV breast cancer; Toremifene

Outcome Measures

Primary Outcomes (1)

• In conjunction with the data from Biomed 777-CLP-29, compare the time to progression (TTP) in the atamestane plus toremifene arm to the TTP in the letrozole plus placebo arm

Secondary Outcomes (1)

• In conjunction with the data from Biomed 777-CLP-29, obtain safety, survival and time to treatment failure (TTF) data for both arms in this continuation study.

Interventions

Atamestane DRUG

toremifene DRUG

letrozole DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Subjects who have withdrawn consent to participate in Biomed 777-CLP-29 for any reason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.

Sponsors & Collaborators

• Intarcia Therapeutics: lead

Study Sites (35)

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Greenbrae, California, United States

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Saint Joseph, Michigan, United States

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Kansas City, Missouri, United States

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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

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MeSH Terms

Conditions

Breast Neoplasms; Neoplasms, Hormone-Dependent; Carcinoma, Ductal, Breast; Carcinoma, Lobular

Interventions

atamestane; Toremifene; Letrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Ductal; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Tamoxifen; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Nitriles; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Peter Langecker, MD, PhD

  Intarcia Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 20, 2005
• First Posted: December 21, 2005
• Study Start: November 1, 2005
• Study Completion: June 1, 2006
• Last Updated: September 10, 2007

Record last verified: 2007-09

Locations

US (6); RU (17); UA (9); CA (3)