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

Sponsor

Centre Francois Baclesse (Other)

Overall Status

Completed

CT.gov ID

NCT00771433

Collaborator

(none)

120

Enrollment

Location

Arms

Study Details

Study Description

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.

PURPOSE: This phase II trial is studying how well G-CSF works in preventing neutropenia in women receiving chemotherapy for breast cancer.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Chemotherapeutic Agent Toxicity Neutropenia	Biological: filgrastim	Phase 2

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

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Non-Randomized

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Oct 1, 2007

Actual Primary Completion Date :

May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Biological: filgrastim Given subcutaneously
Experimental: 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.	Biological: filgrastim Given subcutaneously

Arm

Intervention/Treatment

Experimental: 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.

Biological: filgrastim

Given subcutaneously

Experimental: 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.

Biological: filgrastim

Given subcutaneously

Outcome Measures

Primary Outcome Measures

Occurrence of febrile neutropenia []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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