Filgrastim or Pegfilgrastim in Preventing Neutropenia in Women Receiving Chemotherapy Following Surgery for Breast Cancer
- Conditions
- NeutropeniaBreast Cancer
- Registration Number
- NCT00030758
- Lead Sponsor
- Anglo Celtic Cooperative Oncology Group
- Brief 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. 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 816
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients achieving ≥ 85% of planned dose intensity Proportion of patients with ≥ 1 neutropenic event
- Secondary Outcome Measures
Name Time Method Dose intensity achieved Cost of management
Trial Locations
- Locations (32)
Christie Hospital NHS Trust
🇬🇧Manchester, England, United Kingdom
King's College Hospital
🇬🇧London, England, United Kingdom
St. George's Hospital
🇬🇧London, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
🇬🇧Leeds, England, United Kingdom
Sunderland Royal Hospital
🇬🇧Sunderland, England, United Kingdom
South Tyneside District Hospital
🇬🇧South Shields, England, United Kingdom
Southend University Hospital NHS Foundation Trust
🇬🇧Westcliff-On-Sea, England, United Kingdom
Royal Infirmary - Castle
🇬🇧Glasgow, Scotland, United Kingdom
St. Luke's Cancer Centre at Royal Surrey County Hospital
🇬🇧Guildford, England, United Kingdom
Cheltenham General Hospital
🇬🇧Cheltenham, England, United Kingdom
Sussex Cancer Centre at Royal Sussex County Hospital
🇬🇧Brighton, England, United Kingdom
Queen Elizabeth Hospital NHS Trust
🇬🇧London, England, United Kingdom
King George Hospital
🇬🇧Ilford, Essex, England, United Kingdom
Nottingham City Hospital NHS Trust
🇬🇧Nottingham, England, United Kingdom
Berkshire Cancer Centre at Royal Berkshire Hospital
🇬🇧Reading, England, United Kingdom
Norfolk and Norwich University Hospital
🇬🇧Norwich, England, United Kingdom
Royal Oldham Hospital
🇬🇧Oldham, England, United Kingdom
Oldchurch Hospital
🇬🇧Romford, England, United Kingdom
Yeovil District Hospital
🇬🇧Yeovil - Somerset, England, United Kingdom
West of Scotland Cancer Centre
🇬🇧Glasgow, Scotland, United Kingdom
Raigmore Hospital
🇬🇧Inverness, Scotland, United Kingdom
City Hospital - Birmingham
🇬🇧Birmingham, England, United Kingdom
Princess Alexandra Hospital
🇬🇧Essex, England, United Kingdom
Clatterbridge Centre for Oncology NHS Trust
🇬🇧Merseyside, England, United Kingdom
Ninewells Hospital and Medical School
🇬🇧Dundee, Scotland, United Kingdom
Northampton General Hospital NHS Trust
🇬🇧Northampton, England, United Kingdom
Peterborough Hospitals Trust
🇬🇧Peterborough, England, United Kingdom
Salisbury District Hospital
🇬🇧Salisbury, England, United Kingdom
Cancer Research Centre at Weston Park Hospital
🇬🇧Sheffield, England, United Kingdom
Southampton University Hospital NHS Trust
🇬🇧Southampton, England, United Kingdom
Scottish Cancer Therapy Network
🇬🇧Edinburgh, Scotland, United Kingdom
Singleton Hospital of the Swansea NHS Trust
🇬🇧Swansea, Wales, United Kingdom