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

August 6, 2013 updated by: Anglo Celtic Cooperative Oncology Group

G-CSF (Filgrastim) or Pegfilgrastim Secondary Prophylaxis In The Adjuvant Chemotherapy Of Early Breast Cancer

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

816

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • Birmingham, England, United Kingdom, B18 7QH
        • City Hospital - Birmingham
      • Brighton, England, United Kingdom, BN2 5BE
        • Sussex Cancer Centre at Royal Sussex County Hospital
      • Cheltenham, England, United Kingdom, GL53 7AN
        • Cheltenham General Hospital
      • Essex, England, United Kingdom, CM20 1QX
        • Princess Alexandra Hospital
      • Guildford, England, United Kingdom, GU2 7XX
        • St. Luke's Cancer Centre at Royal Surrey County Hospital
      • Ilford, Essex, England, United Kingdom, IG3 8YB
        • King George Hospital
      • Leeds, England, United Kingdom, LS9 7TF
        • Leeds Cancer Centre at St. James's University Hospital
      • London, England, United Kingdom, SW17 0QT
        • St. George's Hospital
      • London, England, United Kingdom, SE5 9RS
        • King's College Hospital
      • London, England, United Kingdom, SE18 4QH
        • Queen Elizabeth Hospital NHS Trust
      • Manchester, England, United Kingdom, M20 4BX
        • Christie Hospital NHS Trust
      • Merseyside, England, United Kingdom, CH63 4JY
        • Clatterbridge Centre for Oncology NHS Trust
      • Northampton, England, United Kingdom, NN1 5BD
        • Northampton General Hospital NHS Trust
      • Norwich, England, United Kingdom, NR4 7UY
        • Norfolk and Norwich University Hospital
      • Nottingham, England, United Kingdom, NG5 1PB
        • Nottingham City Hospital NHS Trust
      • Oldham, England, United Kingdom, OL1 2JH
        • Royal Oldham Hospital
      • Peterborough, England, United Kingdom, PE3 6DA
        • Peterborough Hospitals Trust
      • Reading, England, United Kingdom, RG1 5AN
        • Berkshire Cancer Centre at Royal Berkshire Hospital
      • Romford, England, United Kingdom, RM7 OBE
        • Oldchurch Hospital
      • Salisbury, England, United Kingdom, SP2 8BJ
        • Salisbury District Hospital
      • Sheffield, England, United Kingdom, S1O 2SJ
        • Cancer Research Centre at Weston Park Hospital
      • South Shields, England, United Kingdom, NE34 0PL
        • South Tyneside District Hospital
      • Southampton, England, United Kingdom, SO16 6YD
        • Southampton University Hospital NHS Trust
      • Sunderland, England, United Kingdom, SR4 7TP
        • Sunderland Royal Hospital
      • Westcliff-On-Sea, England, United Kingdom, SS0 0RY
        • Southend University Hospital NHS Foundation Trust
      • Yeovil - Somerset, England, United Kingdom, BA21 4AT
        • Yeovil District Hospital
    • Scotland
      • Dundee, Scotland, United Kingdom, DD1 9SY
        • Ninewells Hospital and Medical School
      • Edinburgh, Scotland, United Kingdom, EH5 3SQ
        • Scottish Cancer Therapy Network
      • Glasgow, Scotland, United Kingdom, G4 0SF
        • Royal Infirmary - Castle
      • Glasgow, Scotland, United Kingdom, G11 6NT
        • West of Scotland Cancer Centre
      • Inverness, Scotland, United Kingdom, 1V2 3UJ
        • Raigmore Hospital
    • Wales
      • Swansea, Wales, United Kingdom, SA2 8QA
        • Singleton Hospital of the Swansea NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Dose intensity achieved
Cost of management

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anglo Celtic Cooperative Oncology Group

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2001

Study Registration Dates

First Submitted

February 14, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

August 7, 2013

Last Update Submitted That Met QC Criteria

August 6, 2013

Last Verified

June 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACCOG-SCTN-BR0101
  • CDR0000069195 (Registry Identifier: PDQ (Physician Data Query))
  • SCTN-BR0101
  • EU-20143

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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