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

Primary Purpose

Breast Cancer, Chemotherapeutic Agent Toxicity, Neutropenia

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
filgrastim
Sponsored by
Centre Francois Baclesse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No concurrent participation in another experimental drug study

Sites / Locations

  • Centre Regional Francois Baclesse

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1

Group 2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Occurrence of febrile neutropenia

Secondary Outcome Measures

Full Information

First Posted
October 10, 2008
Last Updated
May 12, 2011
Sponsor
Centre Francois Baclesse
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1. Study Identification

Unique Protocol Identification Number
NCT00771433
Brief Title
G-CSF in Preventing Neutropenia in Women Receiving Chemotherapy for Breast Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Centre Francois Baclesse

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Chemotherapeutic Agent Toxicity, Neutropenia
Keywords
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
filgrastim
Intervention Description
Given subcutaneously
Primary Outcome Measure Information:
Title
Occurrence of febrile neutropenia

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corinne Delcambre
Organizational Affiliation
Centre Francois Baclesse
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Regional Francois Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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