G-CSF (Filgrastim) or Pegfilgrastim Secondary Prophylaxis In The Adjuvant Chemotherapy Of Early Breast Cancer
18 Years
N/A
Female
Breast Cancer, Neutropenia
Trial Information
G-CSF (Filgrastim) or Pegfilgrastim Secondary Prophylaxis In The Adjuvant Chemotherapy Of Early Breast Cancer
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.
Inclusion Criteria
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)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Supportive Care
Outcome Measure:
Proportion of patients achieving ≥ 85% of planned dose intensity
Principal Investigator
Robert C.F. Leonard, MD, BS, MB
Investigator Role:
Study Chair
Investigator Affiliation:
Charing Cross Hospital
Authority:
United States: Federal Government
Study ID:
CDR0000069195
NCT ID:
NCT00030758
Start Date:
October 2001
Completion Date:
Related Keywords:
- Breast Cancer
- Neutropenia
- neutropenia
- stage I breast cancer
- stage II breast cancer
- Breast Neoplasms
- Neutropenia
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