Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Centre Francois Baclesse
OBJECTIVES:
Primary
* Evaluate the efficacy of filgrastim (G-CSF) in preventing hematological toxicity in women with breast cancer receiving neoadjuvant or adjuvant chemotherapy.
Secondary
* Compare actual vs theoretical dose intensity.
OUTLINE: This is a multicenter study. Patients are stratified according to age (\< 65 years vs ≥ 65 years) and prior chemotherapy (adjuvant vs neoadjuvant). Patients are assigned to 1 of 2 groups.
* Group 1: Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily on days 6-11 of each course of chemotherapy as primary prophylaxis. Chemotherapy courses repeat every three weeks for 3-6 courses.
* Group 2: Patients receive G-CSF SC once daily on days 6-11 of each course of chemotherapy as primary prophylaxis. Chemotherapy courses repeat every three weeks for 3-6 courses. Patients may also receive secondary prophylaxis with G-CSF if they experience an episode of neutropenia.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
Clareo Health | G-CSF in Preventing Neutropenia in Women Receiving Chemotherapy for Breast Cancer
