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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00771433
Recruitment Status : Completed
First Posted : October 13, 2008
Last Update Posted : May 13, 2011
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE October 10, 2008
First Posted Date  ICMJE October 13, 2008
Last Update Posted Date May 13, 2011
Study Start Date  ICMJE October 2007
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2008)
Occurrence of febrile neutropenia
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00771433 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE G-CSF in Preventing Neutropenia in Women Receiving Chemotherapy for Breast Cancer
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Primary Purpose: Supportive Care
Condition  ICMJE
  • Breast Cancer
  • Chemotherapeutic Agent Toxicity
  • Neutropenia
Intervention  ICMJE Biological: filgrastim
Given subcutaneously
Study Arms  ICMJE
  • 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.
    Intervention: Biological: filgrastim
  • 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.
    Intervention: Biological: filgrastim
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: October 10, 2008)
120
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00771433
Other Study ID Numbers  ICMJE CDR0000599535
FRE-CFB-LENO-SEIN
INCA-RECF0516
EUDRACT-2007-002753-23
FRE-CFB-CFB/2007-01
CHUGAI-FRE-CFB-LENO-SEIN
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Centre Francois Baclesse
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Corinne Delcambre Centre Francois Baclesse
PRS Account National Cancer Institute (NCI)
Verification Date December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP