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

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00267553
• Other study ID #: Biomed 777-CLP-32
• Status: Terminated
• Phase: Phase 3
• First received: December 20, 2005
• Last updated: September 7, 2007
• Start date: November 2005
• Est. completion date: June 2006

Study information

• Verified date: September 2007
• Source: Intarcia Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationRussia: Ministry of Health of the Russian FederationUkraine: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Neoplasms
• Neoplasms, Hormone-Dependent

Intervention

Drug:
• Atamestane

• toremifene

• letrozole

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Intarcia Therapeutics

Countries where clinical trial is conducted

United States,  Canada,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.