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

Sponsored by:	Centre Regional Francois Baclesse
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00771433

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 Cancer-Related Problem/Condition	Drug: filgrastim	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Filgrastim Sargramostim Granulocyte-macrophage colony-stimulating factor Granulocyte colony-stimulating factor

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Non-Randomized
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

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
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group 1: Experimental 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.	Drug: filgrastim Given subcutaneously
Group 2: Experimental 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.	Drug: 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

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

Locations

France
Centre Regional Francois Baclesse	Recruiting
Caen, France, 14076
Contact: Corinne Delcambre 33-2-3145-5000

Sponsors and Collaborators

Centre Regional Francois Baclesse

Investigators

Study Chair:

Corinne Delcambre

Centre Regional Francois Baclesse

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

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:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00771433
Health Authority:	Unspecified

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

Study placed in the following topic categories:

Neutropenia
Skin Diseases
Breast Neoplasms
Breast Diseases
Recurrence

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009