Study of Adriamycin Plus Cyclophosphamide Followed by Abraxane as Adjuvant Therapy for Patients With Breast Cancer
Tracking Information | |||||
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First Received Date ICMJE | April 5, 2005 | ||||
Last Updated Date | July 18, 2007 | ||||
Start Date ICMJE | March 2005 | ||||
Primary Completion Date | |||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00107094 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 | Study of Adriamycin Plus Cyclophosphamide Followed by Abraxane as Adjuvant Therapy for Patients With Breast Cancer | ||||
Official Title ICMJE | An Open Label, Pilot Study of Dose-Dense Adriamycin Plus Cyclophosphamide (AC) Followed by ABI-007 as Adjuvant Therapy for Patients With Breast Cancer | ||||
Brief Summary | In this trial, the safety of combination treatment of Adriamycin plus cyclophosphamide followed by Abraxane as adjuvant therapy will be evaluated in patients with limited stage breast cancer. |
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Detailed Description | This is an open-label, pilot study to evaluate the safety of Adriamycin and cyclophosphamide (AC) administered every 2 weeks for 4 cycles followed by Abraxane administered every 2 weeks for 4 cycles as adjuvant therapy for patients with limited stage breast cancer. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 1 | ||||
Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Breast Cancer | ||||
Intervention ICMJE | Drug: Abraxane | ||||
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 | Completed | ||||
Enrollment ICMJE | 30 | ||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | Inclusion Criteria: A patient will be eligible for inclusion in this study only if all of the following criteria are met:
Exclusion Criteria: A patient will not be eligible for inclusion in this study if any of the following criteria apply:
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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 | NCT00107094 | ||||
Other Study ID Numbers ICMJE | CA030 | ||||
Has Data Monitoring Committee | |||||
Responsible Party | |||||
Study Sponsor ICMJE | Celgene Corporation | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Celgene Corporation | ||||
Verification Date | July 2007 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |