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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00771433
• Other study ID #: CDR0000599535
• Secondary ID: FRE-CFB-LENO-SEI
• Status: Completed
• Phase: Phase 2
• First received: October 10, 2008
• Last updated: May 12, 2011
• Start date: October 2007

Study information

• Verified date: December 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Chemotherapeutic Agent Toxicity
• Neutropenia

Intervention

Biological:
• filgrastim
Given subcutaneously

Locations

Country	Name	City	State
France	Centre Regional Francois Baclesse	Caen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Francois Baclesse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of febrile neutropenia			No