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

Breast Cancer Clinical Trial

Official title:

G-CSF (Filgrastim) or Pegfilgrastim Secondary Prophylaxis In The Adjuvant Chemotherapy Of Early Breast Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00030758
• Other study ID #: ACCOG-SCTN-BR0101
• Secondary ID: CDR0000069195SCT
• Status: Active, not recruiting
• Phase: Phase 4
• First received: February 14, 2002
• Last updated: August 6, 2013
• Start date: October 2001

Study information

• Verified date: June 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 816
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Neutropenia

Intervention

Biological:
• filgrastim

• pegfilgrastim

Locations

Country	Name	City	State
United Kingdom	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	Ninewells Hospital and Medical School	Dundee	Scotland
United Kingdom	Scottish Cancer Therapy Network	Edinburgh	Scotland
United Kingdom	Princess Alexandra Hospital	Essex	England
United Kingdom	Royal Infirmary - Castle	Glasgow	Scotland
United Kingdom	West of Scotland Cancer Centre	Glasgow	Scotland
United Kingdom	St. Luke's Cancer Centre at Royal Surrey County Hospital	Guildford	England
United Kingdom	King George Hospital	Ilford, Essex	England
United Kingdom	Raigmore Hospital	Inverness	Scotland
United Kingdom	Leeds Cancer Centre at St. James's University Hospital	Leeds	England
United Kingdom	King's College Hospital	London	England
United Kingdom	Queen Elizabeth Hospital NHS Trust	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	Singleton Hospital of the Swansea NHS Trust	Swansea	Wales
United Kingdom	Southend University Hospital NHS Foundation Trust	Westcliff-On-Sea	England
United Kingdom	Yeovil District Hospital	Yeovil - Somerset	England

Sponsors (2)

Lead Sponsor	Collaborator
Anglo Celtic Cooperative Oncology Group	Scottish Cancer Therapy Network

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients achieving = 85% of planned dose intensity
Primary	Proportion of patients with = 1 neutropenic event
Secondary	Dose intensity achieved
Secondary	Cost of management