Anastrozole Plus Lonafarnib (SCH 66336) or Plus Placebo for the Treatment of Advanced Breast Cancer (Study P03480AM5)(COMPLETED)
This study has been completed.
Sponsor:
Schering-Plough
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00081510
First received: April 14, 2004
Last updated: October 1, 2009
Last verified: October 2009
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Tracking Information | |
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First Received Date ICMJE | April 14, 2004 |
Last Updated Date | October 1, 2009 |
Start Date ICMJE | December 2003 |
Primary Completion Date | October 2008 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE |
Progression-free survival (PFS) [ Time Frame: When approximately 70 subjects have progressed ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE |
Progression-free survival (PFS), as determined by the central radiology evaluation [ Time Frame: When approximately 70 subjects have progressed ] [ Designated as safety issue: No ] |
Change History | Complete list of historical versions of study NCT00081510 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current |
Current Other Outcome Measures ICMJE | |
Original Other Outcome Measures ICMJE | |
Descriptive Information | |
Brief Title ICMJE | Anastrozole Plus Lonafarnib (SCH 66336) or Plus Placebo for the Treatment of Advanced Breast Cancer (Study P03480AM5)(COMPLETED) |
Official Title ICMJE | A Randomized Double-Blind Phase-2 Study of Anastrozole Plus Lonafarnib (SCH 66336) or Anastrozole Plus Placebo for the Treatment of Subjects With Advanced Breast Cancer |
Brief Summary | Primary Objective(s):
Secondary Objective(s):
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Detailed Description | |
Study Type ICMJE | Interventional |
Study Phase | Phase 2 |
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
Condition ICMJE | Breast Cancer |
Intervention ICMJE |
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Study Arm (s) |
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Publications * | |
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |
Recruitment Status ICMJE | Completed |
Estimated Enrollment ICMJE | 124 |
Completion Date | October 2008 |
Primary Completion Date | October 2008 (final data collection date for primary outcome measure) |
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Female |
Ages | |
Accepts Healthy Volunteers | No |
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
Location Countries ICMJE | |
Administrative Information | |
NCT Number ICMJE | NCT00081510 |
Other Study ID Numbers ICMJE | P03480 |
Has Data Monitoring Committee | No |
Responsible Party | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
Study Sponsor ICMJE | Schering-Plough |
Collaborators ICMJE | |
Investigators ICMJE | |
Information Provided By | Schering-Plough |
Verification Date | October 2009 |
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |