G-CSF in Preventing Neutropenia in Women Receiving Chemotherapy for Breast Cancer (NCT00771433) | Clinical Trial Compass
CompletedPhase 2
G-CSF in Preventing Neutropenia in Women Receiving Chemotherapy for Breast Cancer
France120 participantsStarted 2007-10
Plain-language 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.
PURPOSE: This phase II trial is studying how well G-CSF works in preventing neutropenia in women receiving chemotherapy for breast cancer.
Who can participate
Age range18 Years
SexFEMALE
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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