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Filgrastim or Pegfilgrastim in Preventing Neutropenia in Women Receiving Chemotherapy Following Surgery for Breast Cancer

Primary Purpose

Breast Cancer, Neutropenia

Status
Unknown status
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
filgrastim
pegfilgrastim
Sponsored by
Anglo Celtic Cooperative Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring neutropenia, stage I breast cancer, stage II breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed invasive breast cancer No locally advanced or metastatic breast cancer, including supraclavicular fossa metastases Prior neutropenic event on current chemotherapy regimen, defined as 1 of the following: Hospitalization due to neutropenia Absolute neutrophil count ≤ 1.5 times upper limit of normal and considered sufficiently low to require a treatment delay or a dose reduction > 15% of planned dose Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Not specified Renal: Not specified Other: No other concurrent malignancy Considered suitable risk and fitness status to continue adjuvant chemotherapy PRIOR CONCURRENT THERAPY: Biologic therapy: No prior filgrastim (G-CSF) or pegfilgrastim Chemotherapy: See Disease Characteristics No prior chemotherapy other than current regimen Endocrine therapy: Prior tamoxifen allowed Radiotherapy: Concurrent radiotherapy allowed No concurrent sandwich/synchronous radiotherapy (i.e., administered during a break in the chemotherapy regimen) Surgery: See Disease Characteristics Other: Concurrent enrollment on other licensed chemotherapy trials allowed provided G-CSF is not excluded (e.g., TACT or TANGO trials) Concurrent enrollment in the sequential arm of the SECRAB trial allowed (synchronous arm ineligible)

Sites / Locations

  • City Hospital - Birmingham
  • Sussex Cancer Centre at Royal Sussex County Hospital
  • Cheltenham General Hospital
  • Princess Alexandra Hospital
  • St. Luke's Cancer Centre at Royal Surrey County Hospital
  • King George Hospital
  • Leeds Cancer Centre at St. James's University Hospital
  • Queen Elizabeth Hospital NHS Trust
  • King's College Hospital
  • St. George's Hospital
  • Christie Hospital NHS Trust
  • Clatterbridge Centre for Oncology NHS Trust
  • Northampton General Hospital NHS Trust
  • Norfolk and Norwich University Hospital
  • Nottingham City Hospital NHS Trust
  • Royal Oldham Hospital
  • Peterborough Hospitals Trust
  • Berkshire Cancer Centre at Royal Berkshire Hospital
  • Oldchurch Hospital
  • Salisbury District Hospital
  • Cancer Research Centre at Weston Park Hospital
  • South Tyneside District Hospital
  • Southampton University Hospital NHS Trust
  • Sunderland Royal Hospital
  • Southend University Hospital NHS Foundation Trust
  • Yeovil District Hospital
  • Ninewells Hospital and Medical School
  • Scottish Cancer Therapy Network
  • West of Scotland Cancer Centre
  • Royal Infirmary - Castle
  • Raigmore Hospital
  • Singleton Hospital of the Swansea NHS Trust

Outcomes

Primary Outcome Measures

Proportion of patients achieving ≥ 85% of planned dose intensity
Proportion of patients with ≥ 1 neutropenic event

Secondary Outcome Measures

Dose intensity achieved
Cost of management

Full Information

First Posted
February 14, 2002
Last Updated
August 6, 2013
Sponsor
Anglo Celtic Cooperative Oncology Group
Collaborators
Scottish Cancer Therapy Network
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1. Study Identification

Unique Protocol Identification Number
NCT00030758
Brief Title
Filgrastim or Pegfilgrastim in Preventing Neutropenia in Women Receiving Chemotherapy Following Surgery for Breast Cancer
Official Title
G-CSF (Filgrastim) or Pegfilgrastim Secondary Prophylaxis In The Adjuvant Chemotherapy Of Early Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2007
Overall Recruitment Status
Unknown status
Study Start Date
October 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Anglo Celtic Cooperative Oncology Group
Collaborators
Scottish Cancer Therapy Network

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Colony-stimulating factors, such as filgrastim or pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. It is not yet known whether filgrastim or pegfilgrastim is more effective than standard treatment in preventing neutropenia in women who are receiving adjuvant chemotherapy for breast cancer. PURPOSE: Randomized phase IV trial to compare the effectiveness of filgrastim or pegfilgrastim with that of standard treatment in preventing neutropenia in women who are receiving chemotherapy after undergoing surgery for breast cancer.
Detailed Description
OBJECTIVES: Determine the efficacy of filgrastim (G-CSF) or pegfilgrastim as secondary prophylaxis versus standard management after the first neutropenic event in maintaining dose-intensity of adjuvant chemotherapy in patients with early breast cancer. Determine the proportion of patients who experience at least one neutropenic event. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (60 and under vs over 60) and participating center. Patients receive chemotherapy as per local practice. After the first neutropenic event, patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive filgrastim (G-CSF) subcutaneously (SC) for 7 days beginning 2 days after the final dose in a course of adjuvant chemotherapy (e.g., beginning on day 3 for a course of chemotherapy administered on day 1 only OR beginning on day 10 for a course of chemotherapy administered on days 1 and 8) OR a single dose of pegfilgrastim SC administered approximately 24 hours after chemotherapy that is administered on day 1 only. Arm II: Patients receive standard conservative management. Patients are followed for up to 10 years. PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study within 7 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Neutropenia
Keywords
neutropenia, stage I breast cancer, stage II breast cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Allocation
Randomized
Enrollment
816 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
filgrastim
Intervention Type
Biological
Intervention Name(s)
pegfilgrastim
Primary Outcome Measure Information:
Title
Proportion of patients achieving ≥ 85% of planned dose intensity
Title
Proportion of patients with ≥ 1 neutropenic event
Secondary Outcome Measure Information:
Title
Dose intensity achieved
Title
Cost of management

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed invasive breast cancer No locally advanced or metastatic breast cancer, including supraclavicular fossa metastases Prior neutropenic event on current chemotherapy regimen, defined as 1 of the following: Hospitalization due to neutropenia Absolute neutrophil count ≤ 1.5 times upper limit of normal and considered sufficiently low to require a treatment delay or a dose reduction > 15% of planned dose Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Not specified Renal: Not specified Other: No other concurrent malignancy Considered suitable risk and fitness status to continue adjuvant chemotherapy PRIOR CONCURRENT THERAPY: Biologic therapy: No prior filgrastim (G-CSF) or pegfilgrastim Chemotherapy: See Disease Characteristics No prior chemotherapy other than current regimen Endocrine therapy: Prior tamoxifen allowed Radiotherapy: Concurrent radiotherapy allowed No concurrent sandwich/synchronous radiotherapy (i.e., administered during a break in the chemotherapy regimen) Surgery: See Disease Characteristics Other: Concurrent enrollment on other licensed chemotherapy trials allowed provided G-CSF is not excluded (e.g., TACT or TANGO trials) Concurrent enrollment in the sequential arm of the SECRAB trial allowed (synchronous arm ineligible)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert C.F. Leonard, MD, BS, MB
Organizational Affiliation
Charing Cross Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kirsten Murray
Organizational Affiliation
Scottish Cancer Therapy Network
Official's Role
Study Chair
Facility Information:
Facility Name
City Hospital - Birmingham
City
Birmingham
State/Province
England
ZIP/Postal Code
B18 7QH
Country
United Kingdom
Facility Name
Sussex Cancer Centre at Royal Sussex County Hospital
City
Brighton
State/Province
England
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
Cheltenham General Hospital
City
Cheltenham
State/Province
England
ZIP/Postal Code
GL53 7AN
Country
United Kingdom
Facility Name
Princess Alexandra Hospital
City
Essex
State/Province
England
ZIP/Postal Code
CM20 1QX
Country
United Kingdom
Facility Name
St. Luke's Cancer Centre at Royal Surrey County Hospital
City
Guildford
State/Province
England
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Facility Name
King George Hospital
City
Ilford, Essex
State/Province
England
ZIP/Postal Code
IG3 8YB
Country
United Kingdom
Facility Name
Leeds Cancer Centre at St. James's University Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Queen Elizabeth Hospital NHS Trust
City
London
State/Province
England
ZIP/Postal Code
SE18 4QH
Country
United Kingdom
Facility Name
King's College Hospital
City
London
State/Province
England
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
St. George's Hospital
City
London
State/Province
England
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Christie Hospital NHS Trust
City
Manchester
State/Province
England
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Clatterbridge Centre for Oncology NHS Trust
City
Merseyside
State/Province
England
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Facility Name
Northampton General Hospital NHS Trust
City
Northampton
State/Province
England
ZIP/Postal Code
NN1 5BD
Country
United Kingdom
Facility Name
Norfolk and Norwich University Hospital
City
Norwich
State/Province
England
ZIP/Postal Code
NR4 7UY
Country
United Kingdom
Facility Name
Nottingham City Hospital NHS Trust
City
Nottingham
State/Province
England
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Royal Oldham Hospital
City
Oldham
State/Province
England
ZIP/Postal Code
OL1 2JH
Country
United Kingdom
Facility Name
Peterborough Hospitals Trust
City
Peterborough
State/Province
England
ZIP/Postal Code
PE3 6DA
Country
United Kingdom
Facility Name
Berkshire Cancer Centre at Royal Berkshire Hospital
City
Reading
State/Province
England
ZIP/Postal Code
RG1 5AN
Country
United Kingdom
Facility Name
Oldchurch Hospital
City
Romford
State/Province
England
ZIP/Postal Code
RM7 OBE
Country
United Kingdom
Facility Name
Salisbury District Hospital
City
Salisbury
State/Province
England
ZIP/Postal Code
SP2 8BJ
Country
United Kingdom
Facility Name
Cancer Research Centre at Weston Park Hospital
City
Sheffield
State/Province
England
ZIP/Postal Code
S1O 2SJ
Country
United Kingdom
Facility Name
South Tyneside District Hospital
City
South Shields
State/Province
England
ZIP/Postal Code
NE34 0PL
Country
United Kingdom
Facility Name
Southampton University Hospital NHS Trust
City
Southampton
State/Province
England
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Sunderland Royal Hospital
City
Sunderland
State/Province
England
ZIP/Postal Code
SR4 7TP
Country
United Kingdom
Facility Name
Southend University Hospital NHS Foundation Trust
City
Westcliff-On-Sea
State/Province
England
ZIP/Postal Code
SS0 0RY
Country
United Kingdom
Facility Name
Yeovil District Hospital
City
Yeovil - Somerset
State/Province
England
ZIP/Postal Code
BA21 4AT
Country
United Kingdom
Facility Name
Ninewells Hospital and Medical School
City
Dundee
State/Province
Scotland
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Scottish Cancer Therapy Network
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH5 3SQ
Country
United Kingdom
Facility Name
West of Scotland Cancer Centre
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G11 6NT
Country
United Kingdom
Facility Name
Royal Infirmary - Castle
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G4 0SF
Country
United Kingdom
Facility Name
Raigmore Hospital
City
Inverness
State/Province
Scotland
ZIP/Postal Code
1V2 3UJ
Country
United Kingdom
Facility Name
Singleton Hospital of the Swansea NHS Trust
City
Swansea
State/Province
Wales
ZIP/Postal Code
SA2 8QA
Country
United Kingdom

12. IPD Sharing Statement

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Filgrastim or Pegfilgrastim in Preventing Neutropenia in Women Receiving Chemotherapy Following Surgery for Breast Cancer

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