G-CSF in Preventing Neutropenia in Women Receiving Chemotherapy for Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of the Efficacy of Adding Daily G-CSF (Granulocyte Colony Stimulating Factor) for Prevention of Hematologic Toxicity Due to Neoadjuvant or Adjvuant Chemotherapy in Breast Cancer

Conditions
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Breast Cancer, Chemotherapeutic Agent Toxicity, Neutropenia

Intervention / Treatment
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* Biological: filgrastim


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>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. | Biological: filgrastim<br>* Given subcutaneously<br>|
| Experimental: Group 2<br>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. | Biological: filgrastim<br>* Given subcutaneously<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of febrile neutropenia |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neutropenia, chemotherapeutic agent toxicity, recurrent breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer