Filgrastim or Pegfilgrastim in Preventing Neutropenia in Women Receiving Chemotherapy Following Surgery for Breast Cancer
Recruitment status was Active, not recruiting
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Purpose
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 |
|---|---|---|
|
Breast Cancer Neutropenia |
Biological: filgrastim Biological: pegfilgrastim |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Supportive Care |
| Official Title: | G-CSF (Filgrastim) or Pegfilgrastim Secondary Prophylaxis In The Adjuvant Chemotherapy Of Early Breast Cancer |
- Proportion of patients achieving ≥ 85% of planned dose intensity
- Proportion of patients with ≥ 1 neutropenic event
- Dose intensity achieved
- Cost of management
| Estimated Enrollment: | 816 |
| Study Start Date: | October 2001 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations| United Kingdom | |
| City Hospital - Birmingham | |
| Birmingham, England, United Kingdom, B18 7QH | |
| Sussex Cancer Centre at Royal Sussex County Hospital | |
| Brighton, England, United Kingdom, BN2 5BE | |
| Cheltenham General Hospital | |
| Cheltenham, England, United Kingdom, GL53 7AN | |
| Princess Alexandra Hospital | |
| Essex, England, United Kingdom, CM20 1QX | |
| St. Luke's Cancer Centre at Royal Surrey County Hospital | |
| Guildford, England, United Kingdom, GU2 7XX | |
| King George Hospital | |
| Ilford, Essex, England, United Kingdom, IG3 8YB | |
| Leeds Cancer Centre at St. James's University Hospital | |
| Leeds, England, United Kingdom, LS9 7TF | |
| King's College Hospital | |
| London, England, United Kingdom, SE5 9RS | |
| St. George's Hospital | |
| London, England, United Kingdom, SW17 0QT | |
| Queen Elizabeth Hospital NHS Trust | |
| London, England, United Kingdom, SE18 4QH | |
| Christie Hospital NHS Trust | |
| Manchester, England, United Kingdom, M20 4BX | |
| Clatterbridge Centre for Oncology NHS Trust | |
| Merseyside, England, United Kingdom, CH63 4JY | |
| Northampton General Hospital NHS Trust | |
| Northampton, England, United Kingdom, NN1 5BD | |
| Norfolk and Norwich University Hospital | |
| Norwich, England, United Kingdom, NR4 7UY | |
| Nottingham City Hospital NHS Trust | |
| Nottingham, England, United Kingdom, NG5 1PB | |
| Royal Oldham Hospital | |
| Oldham, England, United Kingdom, OL1 2JH | |
| Peterborough Hospitals Trust | |
| Peterborough, England, United Kingdom, PE3 6DA | |
| Berkshire Cancer Centre at Royal Berkshire Hospital | |
| Reading, England, United Kingdom, RG1 5AN | |
| Oldchurch Hospital | |
| Romford, England, United Kingdom, RM7 OBE | |
| Salisbury District Hospital | |
| Salisbury, England, United Kingdom, SP2 8BJ | |
| Cancer Research Centre at Weston Park Hospital | |
| Sheffield, England, United Kingdom, S1O 2SJ | |
| 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 | |
| Southend University Hospital NHS Foundation Trust | |
| Westcliff-On-Sea, England, United Kingdom, SS0 0RY | |
| Yeovil District Hospital | |
| Yeovil - Somerset, England, United Kingdom, BA21 4AT | |
| Ninewells Hospital and Medical School | |
| Dundee, Scotland, United Kingdom, DD1 9SY | |
| Scottish Cancer Therapy Network | |
| Edinburgh, Scotland, United Kingdom, EH5 3SQ | |
| Royal Infirmary - Castle | |
| Glasgow, Scotland, United Kingdom, G4 0SF | |
| West of Scotland Cancer Centre | |
| Glasgow, Scotland, United Kingdom, G11 6NT | |
| Raigmore Hospital | |
| Inverness, Scotland, United Kingdom, 1V2 3UJ | |
| 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 |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00030758 History of Changes |
| Other Study ID Numbers: | CDR0000069195, ACCOG-SCTN-BR0101, SCTN-BR0101, EU-20143 |
| Study First Received: | February 14, 2002 |
| Last Updated: | May 9, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
neutropenia stage I breast cancer stage II breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neutropenia Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Agranulocytosis Leukopenia |
Leukocyte Disorders Hematologic Diseases Lenograstim Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013