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Sponsors and Collaborators: |
Anglo Celtic Cooperative Oncology Group Scottish Cancer Therapy Network |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00030758 |
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 |
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Breast Cancer Cancer-Related Problem/Condition |
Drug: filgrastim Drug: pegfilgrastim |
Phase IV |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Active Control |
Official Title: | G-CSF (Filgrastim) or Pegfilgrastim Secondary Prophylaxis In The Adjuvant Chemotherapy Of Early Breast Cancer |
Estimated Enrollment: | 816 |
Study Start Date: | October 2001 |
OBJECTIVES:
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.
PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study within 7 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed invasive breast cancer
Prior neutropenic event on current chemotherapy regimen, defined as 1 of the following:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United Kingdom, England | |
Berkshire Cancer Centre at Royal Berkshire Hospital | |
Reading, England, United Kingdom, RG1 5AN | |
Cancer Research Centre at Weston Park Hospital | |
Sheffield, England, United Kingdom, S1O 2SJ | |
Cheltenham General Hospital | |
Cheltenham, England, United Kingdom, GL53 7AN | |
Christie Hospital NHS Trust | |
Manchester, England, United Kingdom, M20 4BX | |
City Hospital - Birmingham | |
Birmingham, England, United Kingdom, B18 7QH | |
Clatterbridge Centre for Oncology NHS Trust | |
Merseyside, England, United Kingdom, CH63 4JY | |
King George Hospital | |
Ilford, Essex, England, United Kingdom, IG3 8YB | |
King's College Hospital | |
London, England, United Kingdom, SE5 9RS | |
Queen Elizabeth Hospital NHS Trust | |
London, England, United Kingdom, SE18 4QH | |
Norfolk and Norwich University Hospital | |
Norwich, England, United Kingdom, NR4 7UY | |
Northampton General Hospital NHS Trust | |
Northampton, England, United Kingdom, NN1 5BD | |
Nottingham City Hospital NHS Trust | |
Nottingham, England, United Kingdom, NG5 1PB | |
Oldchurch Hospital | |
Romford, England, United Kingdom, RM7 OBE | |
Peterborough Hospitals Trust | |
Peterborough, England, United Kingdom, PE3 6DA | |
Princess Alexandra Hospital | |
Essex, England, United Kingdom, CM20 1QX | |
Leeds Cancer Centre at St. James's University Hospital | |
Leeds, England, United Kingdom, LS9 7TF | |
Royal Oldham Hospital | |
Oldham, England, United Kingdom, OL1 2JH | |
Salisbury District Hospital | |
Salisbury, England, United Kingdom, SP2 8BJ | |
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 | |
St. George's Hospital | |
London, England, United Kingdom, SW17 0QT | |
St. Luke's Cancer Centre at Royal Surrey County Hospital | |
Guildford, England, United Kingdom, GU2 7XX | |
Southend University Hospital NHS Foundation Trust | |
Westcliff-On-Sea, England, United Kingdom, SS0 0RY | |
Sussex Cancer Centre at Royal Sussex County Hospital | |
Brighton, England, United Kingdom, BN2 5BE | |
Yeovil District Hospital | |
Yeovil - Somerset, England, United Kingdom, BA21 4AT | |
United Kingdom, Scotland | |
Ninewells Hospital and Medical School | |
Dundee, Scotland, United Kingdom, DD1 9SY | |
Raigmore Hospital | |
Inverness, Scotland, United Kingdom, 1V2 3UJ | |
Royal Infirmary - Castle | |
Glasgow, Scotland, United Kingdom, G4 0SF | |
Scottish Cancer Therapy Network | |
Edinburgh, Scotland, United Kingdom, EH5 3SQ | |
West of Scotland Cancer Centre | |
Glasgow, Scotland, United Kingdom, G11 6NT | |
United Kingdom, Wales | |
Singleton Hospital of the Swansea NHS Trust | |
Swansea, Wales, United Kingdom, SA2 8QA |
Study Chair: | Robert C.F. Leonard, MD, BS, MB | Charing Cross Hospital |
Study Chair: | Kirsten Murray | Scottish Cancer Therapy Network |
Study ID Numbers: | CDR0000069195, ACCOG-SCTN-BR0101, SCTN-BR0101, EU-20143 |
Study First Received: | February 14, 2002 |
Last Updated: | October 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00030758 |
Health Authority: | United States: Federal Government |
neutropenia stage I breast cancer stage II breast cancer |
Neutropenia Skin Diseases Neoplasm Metastasis Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site |