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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Scottish Cancer Therapy Network
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00030758
First received: February 14, 2002
Last updated: August 6, 2013
Last verified: June 2007
  Purpose

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 Intervention Phase
Breast Cancer
Neutropenia
Biological: filgrastim
Biological: pegfilgrastim
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Supportive Care
Official Title: G-CSF (Filgrastim) or Pegfilgrastim Secondary Prophylaxis In The Adjuvant Chemotherapy Of Early Breast Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

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

Estimated Enrollment: 816
Study Start Date: October 2001
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00030758

Locations
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
King's College Hospital
London, England, United Kingdom, SE5 9RS
St. George's Hospital
London, England, United Kingdom, SW17 0QT
Queen Elizabeth Hospital NHS Trust
London, England, United Kingdom, SE18 4QH
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
Royal Infirmary - Castle
Glasgow, Scotland, United Kingdom, G4 0SF
West of Scotland Cancer Centre
Glasgow, Scotland, United Kingdom, G11 6NT
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
Investigators
Study Chair: Robert C.F. Leonard, MD, BS, MB Charing Cross Hospital
Study Chair: Kirsten Murray Scottish Cancer Therapy Network
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00030758     History of Changes
Other Study ID Numbers: ACCOG-SCTN-BR0101, CDR0000069195, SCTN-BR0101, EU-20143
Study First Received: February 14, 2002
Last Updated: August 6, 2013
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Breast Neoplasms
Neutropenia
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014