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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00030758
Recruitment Status : Unknown
Verified June 2007 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : August 7, 2013
Scottish Cancer Therapy Network
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Neutropenia Biological: filgrastim Biological: pegfilgrastim Phase 4

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 816 participants
Allocation: Randomized
Primary Purpose: Supportive Care
Official Title: G-CSF (Filgrastim) or Pegfilgrastim Secondary Prophylaxis In The Adjuvant Chemotherapy Of Early Breast Cancer
Study Start Date : October 2001

Primary Outcome Measures :
  1. Proportion of patients achieving ≥ 85% of planned dose intensity
  2. Proportion of patients with ≥ 1 neutropenic event

Secondary Outcome Measures :
  1. Dose intensity achieved
  2. Cost of management

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over


  • Female

Menopausal status:

  • Not specified

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • See Disease Characteristics


  • Not specified


  • Not specified


  • No other concurrent malignancy
  • Considered suitable risk and fitness status to continue adjuvant chemotherapy


Biologic therapy:

  • No prior filgrastim (G-CSF) or pegfilgrastim


  • See Disease Characteristics
  • No prior chemotherapy other than current regimen

Endocrine therapy:

  • Prior tamoxifen allowed


  • Concurrent radiotherapy allowed
  • No concurrent sandwich/synchronous radiotherapy (i.e., administered during a break in the chemotherapy regimen)


  • See Disease Characteristics


  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00030758

United Kingdom
City Hospital - Birmingham
Birmingham, England, United Kingdom, B18 7QH
Sussex Cancer Centre at Royal Sussex County Hospital
Brighton, England, United Kingdom, BN2 5BE
Cheltenham General Hospital
Cheltenham, England, United Kingdom, GL53 7AN
Princess Alexandra Hospital
Essex, England, United Kingdom, CM20 1QX
St. Luke's Cancer Centre at Royal Surrey County Hospital
Guildford, England, United Kingdom, GU2 7XX
King George Hospital
Ilford, Essex, England, United Kingdom, IG3 8YB
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom, LS9 7TF
Queen Elizabeth Hospital NHS Trust
London, England, United Kingdom, SE18 4QH
King's College Hospital
London, England, United Kingdom, SE5 9RS
St. George's Hospital
London, England, United Kingdom, SW17 0QT
Christie Hospital NHS Trust
Manchester, England, United Kingdom, M20 4BX
Clatterbridge Centre for Oncology NHS Trust
Merseyside, England, United Kingdom, CH63 4JY
Northampton General Hospital NHS Trust
Northampton, England, United Kingdom, NN1 5BD
Norfolk and Norwich University Hospital
Norwich, England, United Kingdom, NR4 7UY
Nottingham City Hospital NHS Trust
Nottingham, England, United Kingdom, NG5 1PB
Royal Oldham Hospital
Oldham, England, United Kingdom, OL1 2JH
Peterborough Hospitals Trust
Peterborough, England, United Kingdom, PE3 6DA
Berkshire Cancer Centre at Royal Berkshire Hospital
Reading, England, United Kingdom, RG1 5AN
Oldchurch Hospital
Romford, England, United Kingdom, RM7 OBE
Salisbury District Hospital
Salisbury, England, United Kingdom, SP2 8BJ
Cancer Research Centre at Weston Park Hospital
Sheffield, England, United Kingdom, S1O 2SJ
South Tyneside District Hospital
South Shields, England, United Kingdom, NE34 0PL
Southampton University Hospital NHS Trust
Southampton, England, United Kingdom, SO16 6YD
Sunderland Royal Hospital
Sunderland, England, United Kingdom, SR4 7TP
Southend University Hospital NHS Foundation Trust
Westcliff-On-Sea, England, United Kingdom, SS0 0RY
Yeovil District Hospital
Yeovil - Somerset, England, United Kingdom, BA21 4AT
Ninewells Hospital and Medical School
Dundee, Scotland, United Kingdom, DD1 9SY
Scottish Cancer Therapy Network
Edinburgh, Scotland, United Kingdom, EH5 3SQ
West of Scotland Cancer Centre
Glasgow, Scotland, United Kingdom, G11 6NT
Royal Infirmary - Castle
Glasgow, Scotland, United Kingdom, G4 0SF
Raigmore Hospital
Inverness, Scotland, United Kingdom, 1V2 3UJ
Singleton Hospital of the Swansea NHS Trust
Swansea, Wales, United Kingdom, SA2 8QA
Sponsors and Collaborators
Anglo Celtic Cooperative Oncology Group
Scottish Cancer Therapy Network
Study Chair: Robert C.F. Leonard, MD, BS, MB Charing Cross Hospital
Study Chair: Kirsten Murray Scottish Cancer Therapy Network Identifier: NCT00030758     History of Changes
Other Study ID Numbers: ACCOG-SCTN-BR0101
CDR0000069195 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: June 2007

Keywords provided by National Cancer Institute (NCI):
stage I breast cancer
stage II breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Leukocyte Disorders
Hematologic Diseases
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs