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

September 7, 2007 updated by: Intarcia Therapeutics

Open Label Treatment and Survival Continuation 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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada
      • Thunder Bay, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
  • Russian Federation
      • Arkhangelsk, Russian Federation
      • Kazan, Russian Federation
      • Krasnodar, Russian Federation
      • Leningrad Region, Russian Federation
      • Lipetsk, Russian Federation
      • Moscow, Russian Federation
      • Murmansk, Russian Federation
      • N. Novgorod, Russian Federation
      • Novgorod, Russian Federation
      • Novosibirsk, Russian Federation
      • Obninsk, Russian Federation
      • Ryazan, Russian Federation
      • Samara, Russian Federation
      • St. Petersburg, Russian Federation
      • Stavropol, Russian Federation
      • Tomsk, Russian Federation
      • Voronezh, Russian Federation
  • Ukraine
      • Dnepropetrovsk, Ukraine
      • Donetsk, Ukraine
      • Ivano-Frankovsk, Ukraine
      • Kharkov, Ukraine
      • Kiev, Ukraine
      • Krivoy Rog, Ukraine
      • Lviv, Ukraine
      • Odessa, Ukraine
      • Uzhgorod, Ukraine
  • United States
    • California
      • Greenbrae, California, United States
    • Michigan
      • St. Joseph, Michigan, United States
    • Missouri
      • Kansas City, Missouri, United States
    • Texas
      • Houston, Texas, United States
    • Virginia
      • Norfolk, Virginia, United States
    • Washington
      • Lacey, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intarcia Therapeutics

Investigators

  • Study Director: Peter Langecker, MD, PhD, Intarcia Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

December 20, 2005

First Submitted That Met QC Criteria

December 20, 2005

First Posted (Estimate)

December 21, 2005

Study Record Updates

Last Update Posted (Estimate)

September 10, 2007

Last Update Submitted That Met QC Criteria

September 7, 2007

Last Verified

September 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Biomed 777-CLP-32

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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