Filgrastim or Pegfilgrastim in Preventing Neutropenia in Women Receiving Chemotherapy Following Surgery for Breast Cancer
NCT ID: NCT00030758
Last Updated: 2013-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
816 participants
INTERVENTIONAL
2001-10-31
Brief Summary
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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.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SUPPORTIVE_CARE
Interventions
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filgrastim
pegfilgrastim
Eligibility Criteria
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Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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Scottish Cancer Therapy Network
OTHER
Anglo Celtic Cooperative Oncology Group
OTHER
Principal Investigators
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Robert C.F. Leonard, MD, BS, MB
Role: STUDY_CHAIR
Charing Cross Hospital
Kirsten Murray
Role: STUDY_CHAIR
Scottish Cancer Therapy Network
Locations
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City Hospital - Birmingham
Birmingham, England, United Kingdom
Sussex Cancer Centre at Royal Sussex County Hospital
Brighton, England, United Kingdom
Cheltenham General Hospital
Cheltenham, England, United Kingdom
Princess Alexandra Hospital
Essex, England, United Kingdom
St. Luke's Cancer Centre at Royal Surrey County Hospital
Guildford, England, United Kingdom
King George Hospital
Ilford, Essex, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom
Queen Elizabeth Hospital NHS Trust
London, England, United Kingdom
King's College Hospital
London, England, United Kingdom
St. George's Hospital
London, England, United Kingdom
Christie Hospital NHS Trust
Manchester, England, United Kingdom
Clatterbridge Centre for Oncology NHS Trust
Merseyside, England, United Kingdom
Northampton General Hospital NHS Trust
Northampton, England, United Kingdom
Norfolk and Norwich University Hospital
Norwich, England, United Kingdom
Nottingham City Hospital NHS Trust
Nottingham, England, United Kingdom
Royal Oldham Hospital
Oldham, England, United Kingdom
Peterborough Hospitals Trust
Peterborough, England, United Kingdom
Berkshire Cancer Centre at Royal Berkshire Hospital
Reading, England, United Kingdom
Oldchurch Hospital
Romford, England, United Kingdom
Salisbury District Hospital
Salisbury, England, United Kingdom
Cancer Research Centre at Weston Park Hospital
Sheffield, England, United Kingdom
South Tyneside District Hospital
South Shields, England, United Kingdom
Southampton University Hospital NHS Trust
Southampton, England, United Kingdom
Sunderland Royal Hospital
Sunderland, England, United Kingdom
Southend University Hospital NHS Foundation Trust
Westcliff-on-Sea, England, United Kingdom
Yeovil District Hospital
Yeovil - Somerset, England, United Kingdom
Ninewells Hospital and Medical School
Dundee, Scotland, United Kingdom
Scottish Cancer Therapy Network
Edinburgh, Scotland, United Kingdom
West of Scotland Cancer Centre
Glasgow, Scotland, United Kingdom
Royal Infirmary - Castle
Glasgow, Scotland, United Kingdom
Raigmore Hospital
Inverness, Scotland, United Kingdom
Singleton Hospital of the Swansea NHS Trust
Swansea, Wales, United Kingdom
Countries
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Other Identifiers
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CDR0000069195
Identifier Type: REGISTRY
Identifier Source: secondary_id
SCTN-BR0101
Identifier Type: -
Identifier Source: secondary_id
EU-20143
Identifier Type: -
Identifier Source: secondary_id
ACCOG-SCTN-BR0101
Identifier Type: -
Identifier Source: org_study_id