TAC Versus TC for Adjuvant Breast Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
US Oncology Research
Collaborator:
Sanofi-Aventis
Information provided by:
US Oncology Research
ClinicalTrials.gov Identifier:
NCT00493870
First received: June 27, 2007
Last updated: June 25, 2009
Last verified: June 2009
Tracking Information | |||||
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First Received Date ICMJE | June 27, 2007 | ||||
Last Updated Date | June 25, 2009 | ||||
Start Date ICMJE | May 2007 | ||||
Estimated Primary Completion Date | May 2015 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
to compare the 3-year DFS of adjuvant TC versus TAC as treatment for early stage HER2-negative breast cancer. [ Time Frame: 3-year ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00493870 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | TAC Versus TC for Adjuvant Breast Cancer | ||||
Official Title ICMJE | Phase III Trial of TC Versus TAC in HER2-Negative Early Stage Breast Cancer Patients | ||||
Brief Summary | The purpose of this research study is to find out what effects (good and bad) TC or TAC has on you and your early stage HER2- breast cancer. |
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Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 3 | ||||
Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Breast Cancer | ||||
Intervention ICMJE |
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Study Arm (s) | |||||
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 | Active, not recruiting | ||||
Estimated Enrollment ICMJE | 2000 | ||||
Estimated Completion Date | May 2015 | ||||
Estimated Primary Completion Date | May 2015 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria: A woman will be eligible for inclusion in this study if she meets all of the following criteria:
Exclusion Criteria: A woman will be excluded from this study if she meets any of the following criteria:
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Gender | Female | ||||
Ages | 18 Years to 70 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00493870 | ||||
Other Study ID Numbers ICMJE | 11271 | ||||
Has Data Monitoring Committee | |||||
Responsible Party | Regulatory Manager, US Oncology Research, Inc. | ||||
Study Sponsor ICMJE | US Oncology Research | ||||
Collaborators ICMJE | Sanofi-Aventis | ||||
Investigators ICMJE |
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Information Provided By | US Oncology Research | ||||
Verification Date | June 2009 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |