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Breast CancerPhase 4NCT00030758

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

A Phase 4 study testing filgrastim and pegfilgrastim in people with Breast Cancer and Neutropenia, run by Anglo Celtic Cooperative Oncology Group at 32 sites in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer, Neutropenia
What is being tested?
filgrastim and pegfilgrastim
How many people
816 participants
Where
32 sitesUnited Kingdom
Study dates
Oct 2001to not given
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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)

Trial locations and contacts

32 sites in 1 country.

32 sites in 1 country

United Kingdom32 sites

  • City Hospital - Birmingham

    Birmingham, England, B18 7QH

  • Sussex Cancer Centre at Royal Sussex County Hospital

    Brighton, England, BN2 5BE

  • Cheltenham General Hospital

    Cheltenham, England, GL53 7AN

  • Ninewells Hospital and Medical School

    Dundee, Scotland, DD1 9SY

  • Scottish Cancer Therapy Network

    Edinburgh, Scotland, EH5 3SQ

  • Princess Alexandra Hospital

    Essex, England, CM20 1QX

  • West of Scotland Cancer Centre

    Glasgow, Scotland, G11 6NT

  • Royal Infirmary - Castle

    Glasgow, Scotland, G4 0SF

  • St. Luke's Cancer Centre at Royal Surrey County Hospital

    Guildford, England, GU2 7XX

  • King George Hospital

    Ilford, Essex, England, IG3 8YB

  • Raigmore Hospital

    Inverness, Scotland, 1V2 3UJ

  • Leeds Cancer Centre at St. James's University Hospital

    Leeds, England, LS9 7TF

  • Queen Elizabeth Hospital NHS Trust

    London, England, SE18 4QH

  • King's College Hospital

    London, England, SE5 9RS

  • St. George's Hospital

    London, England, SW17 0QT

  • Christie Hospital NHS Trust

    Manchester, England, M20 4BX

  • Clatterbridge Centre for Oncology NHS Trust

    Merseyside, England, CH63 4JY

  • Northampton General Hospital NHS Trust

    Northampton, England, NN1 5BD

  • Norfolk and Norwich University Hospital

    Norwich, England, NR4 7UY

  • Nottingham City Hospital NHS Trust

    Nottingham, England, NG5 1PB

  • Royal Oldham Hospital

    Oldham, England, OL1 2JH

  • Peterborough Hospitals Trust

    Peterborough, England, PE3 6DA

  • Berkshire Cancer Centre at Royal Berkshire Hospital

    Reading, England, RG1 5AN

  • Oldchurch Hospital

    Romford, England, RM7 OBE

  • Salisbury District Hospital

    Salisbury, England, SP2 8BJ

  • Cancer Research Centre at Weston Park Hospital

    Sheffield, England, S1O 2SJ

  • South Tyneside District Hospital

    South Shields, England, NE34 0PL

  • Southampton University Hospital NHS Trust

    Southampton, England, SO16 6YD

  • Sunderland Royal Hospital

    Sunderland, England, SR4 7TP

  • Singleton Hospital of the Swansea NHS Trust

    Swansea, Wales, SA2 8QA

  • Southend University Hospital NHS Foundation Trust

    Westcliff-on-Sea, England, SS0 0RY

  • Yeovil District Hospital

    Yeovil - Somerset, England, BA21 4AT

Other trials in United Kingdom

About this study

Official title: 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.

Read the 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.

Keywords
neutropenia, stage I breast cancer, stage II breast cancer
Medical subject headings
Breast Neoplasms, Neutropenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients achieving ≥ 85% of planned dose intensity

  2. Proportion of patients with ≥ 1 neutropenic event

Secondary outcomes (2)

  1. Dose intensity achieved

  2. Cost of management

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startOct 2001

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomised
Enrolment
816 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00030758
Sponsor's protocol ID
ACCOG-SCTN-BR0101
Other IDs
CDR0000069195, SCTN-BR0101, EU-20143
Status last verified
Jun 2007
First submitted
14 Feb 2002
Last updated
7 Aug 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing filgrastim and pegfilgrastim in people with Breast Cancer and Neutropenia, run by Anglo Celtic Cooperative Oncology Group at 32 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients achieving ≥ 85% of planned dose intensity. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00030758.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2013.

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