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Tracking Information | |||||
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First Received Date † | August 10, 2001 | ||||
Last Updated Date | February 6, 2009 | ||||
Start Date † | November 2000 | ||||
Current Primary Outcome Measures † |
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Original Primary Outcome Measures † |
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Change History | Complete list of historical versions of study NCT00022516 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † | |||||
Original Secondary Outcome Measures † | |||||
Descriptive Information | |||||
Brief Title † | Combination Chemotherapy After Surgery in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer | ||||
Official Title † | Maintenance Chemotherapy In Hormone Non-Responsive Breast Cancer, Assessment of Vascular Endothelial Growth Factor (VEGF), Soluble Her2 Protein (NRP, HER2-ECD) and Vascular Cellular Adhesion Molecule-1 (VCAM-1) in Serum Samples | ||||
Brief Summary | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective after surgery in treating breast cancer. PURPOSE: Randomized phase III trial to compare different combination chemotherapy regimens in treating patients who have stage I, stage II, or stage III breast cancer. |
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Detailed Description | OBJECTIVES:
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center, menopausal status (pre vs post), and approved induction chemotherapy (doxorubicin and cyclophosphamide vs other agents). Patients are randomized to one of two treatment arms.
Patients with HER2-positive primary breast cancer may also receive trastuzumab (Herceptin) during or following induction, and/or during and following CM. Quality of life is assessed at baseline, at the beginning of each course of induction chemotherapy, and at months 9, 12, 18, and 24. Patients are followed every 6 months for 5 years and then annually thereafter. PROJECTED ACCRUAL: Approximately 900 patients will be accrued for this study within 5 years. |
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Study Phase | Phase III | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Open Label, Active Control | ||||
Condition † | Breast Cancer | ||||
Intervention † |
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Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Recruiting | ||||
Enrollment † | 990 | ||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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Gender | Both | ||||
Ages | |||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | Australia, Belgium, Brazil, Chile, Hungary, Italy, Nigeria, Peru, Romania, South Africa, Switzerland | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00022516 | ||||
Responsible Party | |||||
Secondary IDs †† | IBCSG-22-00, EU-20119, EUDRACT-2005-005666-36 | ||||
Study Sponsor † | International Breast Cancer Study Group | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | September 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |