Combination Chemotherapy With or Without Darbepoetin Alfa in Treating Women With Stage III Breast Cancer
|First Received Date ICMJE||March 29, 2006|
|Last Updated Date||February 6, 2009|
|Start Date ICMJE||January 2004|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Disease-free survival at 6 months to 5 years after treatment|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00309920 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Combination Chemotherapy With or Without Darbepoetin Alfa in Treating Women With Stage III Breast Cancer|
|Official Title ICMJE||Adjuvant Therapy of Breast Cancer: Impact of Erythropoiesis Stimulating Factors on Event Free Survival High Risk Breast Cancer Treatment|
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Colony-stimulating factors, such as darbepoetin alfa, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving combination chemotherapy together with darbepoetin alfa after surgery may kill any tumor cells that remain after surgery. It is not yet known whether combination chemotherapy and darbepoetin alfa are more effective than combination chemotherapy alone in treating stage III breast cancer.
PURPOSE: This randomized clinical trial is studying how well giving combination chemotherapy together with darbepoetin alfa works compared to combination chemotherapy alone in treating women with stage III breast cancer.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according the chemotherapy regimen (CEF vs TAC). Patients are randomized to 1 of 2 treatment arms.
Treatment repeats every 3 weeks for 6 courses in the absence of disease progression and unacceptable toxicity.
Quality of life is assessed at baseline, before each chemotherapy course, at the completion of study therapy, and at 6 and 12 months.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 1,234 patients will be accrued for this study.
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Condition ICMJE||Breast Cancer|
|Study Arms||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||1234|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
PRIOR CONCURRENT THERAPY:
|Ages||18 Years to 65 Years (Adult)|
|Accepts Healthy Volunteers||No|
|Listed Location Countries ICMJE||Germany|
|Removed Location Countries|
|NCT Number ICMJE||NCT00309920|
|Other Study ID Numbers ICMJE||CDR0000458037, WGSG-ARA-PLUS, AVENTIS-WGSG-ARA-PLUS, SANOFI-WGSF-ARA-PLUS, EU-205108|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Heinrich-Heine University, Duesseldorf|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Cancer Institute (NCI)|
|Verification Date||April 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP