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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00771433
First received: October 10, 2008
Last updated: May 12, 2011
Last verified: December 2008
  Purpose

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 Intervention Phase
Breast Cancer
Chemotherapeutic Agent Toxicity
Neutropenia
Biological: filgrastim
Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Occurrence of febrile neutropenia [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: October 2007
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00771433

Locations
France
Centre Regional Francois Baclesse
Caen, France, 14076
Sponsors and Collaborators
Centre Francois Baclesse
Investigators
Study Chair: Corinne Delcambre Centre Francois Baclesse
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00771433     History of Changes
Other Study ID Numbers: CDR0000599535, FRE-CFB-LENO-SEIN, INCA-RECF0516, EUDRACT-2007-002753-23, FRE-CFB-CFB/2007-01, CHUGAI-FRE-CFB-LENO-SEIN
Study First Received: October 10, 2008
Last Updated: May 12, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Breast Neoplasms
Neutropenia
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014