Status:
UNKNOWN
Combination Chemotherapy With or Without Darbepoetin Alfa in Treating Women With Stage III Breast Cancer
Lead Sponsor:
Heinrich-Heine University, Duesseldorf
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-65 years
Phase:
NA
Brief Summary
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 ch...
Detailed Description
OBJECTIVES: Primary * Compare the disease-free survival rate in women with stage III breast cancer treated with adjuvant chemotherapy with vs without darbepoetin alfa. Secondary * Compare local re...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed breast cancer
- Stage III disease (pT1, N2-3, M0)
- No metastatic disease by thoracic x-ray, full-body bone scan, and liver sonography
- No inflammatory disease or Paget's disease
- Disease completely resected (R0) and ≥ 10 axillary lymph nodes removed
- Underwent surgery approximately 42 days ago
- At least 9 positive lymph nodes
- No prior sequential mastectomy
- Hormone receptor status not specified
- PATIENT CHARACTERISTICS:
- Female
- Menopausal status not specified
- ECOG performance status 0-1
- WBC ≥ 3,500/mm\^3
- Creatinine ≤ 1.4 mg/dL
- Platelet count ≥ 100,000/mm\^3
- Bilirubin ≤ 2.0 mg/dL
- No pre-existing symptomatic peripheral neuropathy
- Not pregnant or nursing
- No hypersensitivity to darbepoetin alfa, epoetin alfa, or any of their components
- No other malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No participation in another clinical study
- No prior therapies that would preclude study participation
Exclusion
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
1234 Patients enrolled
Trial Details
Trial ID
NCT00309920
Start Date
January 1 2004
Last Update
February 9 2009
Active Locations (47)
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1
Kreiskrankenhaus Aurich
Aurich, Germany, D-26603
2
Maria-Hilf-Krankenhaus
Bergheim, Germany, D-50126
3
Evangelisches Krankenhaus - Bergisch Gladbach
Bergisch, Germany, D-51465
4
Johanniter-Krankenhaus Bonn
Bonn, Germany, D-53113