NCT00771433

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

October 10, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 13, 2008

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Last Updated

May 13, 2011

Status Verified

December 1, 2008

Enrollment Period

3.6 years

First QC Date

October 10, 2008

Last Update Submit

May 12, 2011

Conditions

Breast CancerChemotherapeutic Agent ToxicityNeutropenia

Keywords

neutropeniachemotherapeutic agent toxicityrecurrent breast cancerstage I breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage IV breast cancer

Outcome Measures

Primary Outcomes (1)

  • Occurrence of febrile neutropenia

Study Arms (2)

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.

Biological: filgrastim

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.

Biological: filgrastim

Interventions

filgrastimBIOLOGICAL

Given subcutaneously

Group 1Group 2

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Centre Regional Francois Baclesse

Caen, 14076, France

Location

MeSH Terms

Conditions

Breast NeoplasmsNeutropenia

Interventions

Filgrastim

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAgranulocytosisLeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte Disorders

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Corinne Delcambre

    Centre Francois Baclesse

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 10, 2008

First Posted

October 13, 2008

Study Start

October 1, 2007

Primary Completion

May 1, 2011

Last Updated

May 13, 2011

Record last verified: 2008-12

Locations

FR(1)