Status:
TERMINATED
Treatment and Survival Continuation Study of Atamestane Plus Toremifene vs Letrozole in Advanced Breast Cancer
Lead Sponsor:
Intarcia Therapeutics
Conditions:
Breast Neoplasms
Neoplasms, Hormone-Dependent
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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) ata...
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 cel...
Eligibility Criteria
Inclusion
- 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
- Subjects who have withdrawn consent to participate in Biomed 777-CLP-29 for any reason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.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
End Date :
June 1 2006
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00267553
Start Date
November 1 2005
End Date
June 1 2006
Last Update
September 10 2007
Active Locations (35)
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1
Greenbrae, California, United States
2
Saint Joseph, Michigan, United States
3
Kansas City, Missouri, United States
4
Houston, Texas, United States