Adjuvant Epirubicin/Cytoxan Followed By A Taxane VS. Epirubicin/Taxane As Treatment For Node-Positive Breast Cancer
NCT00140075
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- Breast Cancer Stage T1-3, N1, M0
- Suitable candidate for anthracycline-containing adjuvant chemotherapy
- Evidence of residual tumor following surgery, or metastatic disease
- Received prior therapy for breast cancer
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Descriptive Information | ||||
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Brief Title ICMJE | Adjuvant Epirubicin/Cytoxan Followed By A Taxane VS. Epirubicin/Taxane As Treatment For Node-Positive Breast Cancer | |||
Official Title ICMJE | Phase III, Randomized Study Of Epirubicin/Cyclophosphamide Followed By Taxane (Sequential Chemotherapy) Versus Epirubicin/Taxane (Concurrent Chemotherapy) As Adjuvant Treatment For Operable, Node-Positive Breast Cancer | |||
Brief Summary | The purpose of this study is to compare two combinations of drugs, epirubicin given with a taxane (ET) or epirubicin given with cyclophosphamide (cytoxan) and followed by a taxane to see if one of the combinations is better at preventing or delaying the time for breast cancer recurrence and death after 3 years. The study will also evaluate the side effects of both treatment combinations. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Adenocarcinoma | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 606 | |||
Original Enrollment ICMJE | 617 | |||
Actual Study Completion Date ICMJE | August 2006 | |||
Actual Primary Completion Date | August 2006 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00140075 | |||
Other Study ID Numbers ICMJE | 378-ONC-0030-184 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer Inc | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | May 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |