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Filgrastim or Pegfilgrastim in Preventing Neutropenia in Women Receiving Chemotherapy Following Surgery for Breast Cancer

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ClinicalTrials.gov Identifier: NCT00030758
Recruitment Status : Unknown
Verified June 2007 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : August 7, 2013
Sponsor:
Collaborator:
Scottish Cancer Therapy Network
Information provided by:
National Cancer Institute (NCI)

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.


Condition or disease Intervention/treatment Phase
Breast Cancer Neutropenia Biological: filgrastim Biological: pegfilgrastim Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 816 participants
Allocation: Randomized
Primary Purpose: Supportive Care
Official Title: G-CSF (Filgrastim) or Pegfilgrastim Secondary Prophylaxis In The Adjuvant Chemotherapy Of Early Breast Cancer
Study Start Date : October 2001





Primary Outcome Measures :
  1. Proportion of patients achieving ≥ 85% of planned dose intensity
  2. Proportion of patients with ≥ 1 neutropenic event

Secondary Outcome Measures :
  1. Dose intensity achieved
  2. Cost of management


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00030758


Locations
Show Show 32 study locations
Sponsors and Collaborators
Anglo Celtic Cooperative Oncology Group
Scottish Cancer Therapy Network
Investigators
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Study Chair: Robert C.F. Leonard, MD, BS, MB Charing Cross Hospital
Study Chair: Kirsten Murray Scottish Cancer Therapy Network
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ClinicalTrials.gov Identifier: NCT00030758    
Other Study ID Numbers: ACCOG-SCTN-BR0101
CDR0000069195 ( Registry Identifier: PDQ (Physician Data Query) )
SCTN-BR0101
EU-20143
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: June 2007
Keywords provided by National Cancer Institute (NCI):
neutropenia
stage I breast cancer
stage II breast cancer
Additional relevant MeSH terms:
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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