Status:
COMPLETED
G-CSF in Preventing Neutropenia in Women Receiving Chemotherapy for Breast Cancer
Lead Sponsor:
Centre Francois Baclesse
Conditions:
Breast Cancer
Chemotherapeutic Agent Toxicity
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: G-CSF may prevent or reduce febrile neutropenia in women receiving chemotherapy for breast cancer. It is not yet known which G-CSF regimen is more effective in preventing neutropenia. PURP...
Detailed Description
OBJECTIVES: Primary * Evaluate the efficacy of filgrastim (G-CSF) in preventing hematological toxicity in women with breast cancer receiving neoadjuvant or adjuvant chemotherapy. Secondary * Compa...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of breast cancer
- Receiving 1 of the following neoadjuvant or adjuvant chemotherapy regimens:
- Six courses of epirubicin hydrochloride and docetaxel
- Six courses of fluorouracil, epirubicin hydrochloride, and cyclophosphamide (FEC) 100 or 3 courses of FEC 100 and 3 courses of docetaxel 100
- Must have received at least 2 chemotherapy regimens prior to study therapy
- No malignant hematological disease
- Hormone receptor status not specified
- PATIENT CHARACTERISTICS:
- Menopausal status not specified
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No contraindications to standard neoadjuvant or adjuvant chemotherapy
- No known hypersensitivity to G-CSF or any of its components
- No patients deprived of liberty or under guardianship
- No psychological, familial, social, or geographical reasons preventing follow-up
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No concurrent participation in another experimental drug study
Exclusion
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00771433
Start Date
October 1 2007
Last Update
May 13 2011
Active Locations (1)
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1
Centre Regional Francois Baclesse
Caen, France, 14076