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 III 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	Treatment or Intervention	Phase
Neutropenia stage I breast cancer stage II breast cancer	Drug: filgrastim  Drug: pegfilgrastim  Procedure: hematologic toxicity attenuation  Procedure: supportive care/therapy	Phase III

Further Study Details: 

OBJECTIVES:

• Determine the efficacy of filgrastim (G-CSF) or pegfilgrastim as secondary prophylaxis versus standard management 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 adjuvant 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 816 patients (408 per treatment arm) will be accrued for this study within 3 years.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed invasive breast cancer
• No locally advanced or metastatic breast cancer, including supraclavicular fossa metastases
• Prior neutropenic event on current adjuvant IV chemotherapy regimen, defined as 1 of the following:
• Hospitalization due to neutropenia
• Absolute neutrophil count no greater than 1,000/mm^3 immediately before next course, necessitating treatment delay or reduction
• 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)

United Kingdom, England
      Cancer Research Centre at Weston Park Hospital, Sheffield,  England,  S1O 2SJ,  United Kingdom; Recruiting
      Cheltenham General Hospital, Cheltenham,  England,  GL53 7AN,  United Kingdom; Recruiting
      Christie Hospital N.H.S. Trust, Manchester,  England,  M20 4BX,  United Kingdom; Recruiting
      City Hospital - Birmingham, Birmingham,  England,  B18 7QH,  United Kingdom; Recruiting
      Clatterbridge Centre for Oncology NHS Trust, MERSEYSIDE,  England,  CH63 4JY,  United Kingdom; Recruiting
      King George Hospital, Ilford, Essex,  England,  IG3 8YB,  United Kingdom; Recruiting
      King's College Hospital, London,  England,  SE5 9RS,  United Kingdom; Recruiting
      Norfolk and Norwich University Hospital, Norwich,  England,  NR4 7UY,  United Kingdom; Recruiting
      Northampton General Hospital NHS Trust, Northampton,  England,  NN1 5BD,  United Kingdom; Recruiting
      Nottingham City Hospital NHS Trust, Nottingham,  England,  NG5 1PB,  United Kingdom; Recruiting
      Oldchurch Hospital, Romford,  England,  RM7 OBE,  United Kingdom; Recruiting
      Peterborough Hospitals Trust, Peterborough,  England,  PE3 6DA,  United Kingdom; Recruiting
      Princess Alexandra Hospital, Essex,  England,  CM20 1QX,  United Kingdom; Recruiting
      Queen Elizabeth Hospital NHS Trust, London,  England,  SE18 4QH,  United Kingdom; Recruiting
      Royal Berkshire Hospital, Reading,  England,  RG1 5AN,  United Kingdom; Recruiting
      Royal Oldham Hospital, Oldham,  England,  OL1 2JH,  United Kingdom; Recruiting
      Royal Sussex County Hospital, Brighton,  England,  BN2 5BE,  United Kingdom; Recruiting
      Salisbury District Hospital, Salisbury,  England,  SP2 8BJ,  United Kingdom; Recruiting
      South Tyneside District Hospital, South Shields,  England,  NE34 0PL,  United Kingdom; Recruiting
      Southampton General Hospital, Southampton,  England,  SO16 6YD,  United Kingdom; Recruiting
      Southend NHS Trust Hospital, Westcliff-On-Sea,  England,  SS0 0RY,  United Kingdom; Recruiting
      St. George's Hospital, London,  England,  SW17 0QT,  United Kingdom; Recruiting
      St. James's University Hospital at Leeds Teaching Hospital NHS Trust, Leeds,  England,  LS9 7TF,  United Kingdom; Recruiting
      St. Luke's Cancer Centre at Royal Surrey County Hospital, Guildford,  England,  GU2 5XX,  United Kingdom; Recruiting
      Sunderland Royal Hospital, Sunderland,  England,  SR4 7TP,  United Kingdom; Recruiting
      Yeovil District Hospital, Yeovil - Somerset,  England,  BA21 4AT,  United Kingdom; Recruiting
United Kingdom, Scotland
      Beatson Oncology Centre, Glasgow,  Scotland,  G11 6NT,  United Kingdom; Recruiting
      Ninewells Hospital and Medical School, Dundee,  Scotland,  DD1 9SY,  United Kingdom; Recruiting
      Raigmore Hospital, Inverness,  Scotland,  1V2 3UJ,  United Kingdom; Recruiting
      Royal Infirmary - Castle, Glasgow,  Scotland,  G4 0SF,  United Kingdom; Recruiting
      Scottish Cancer Therapy Network, Edinburgh,  Scotland,  EH5 3SQ,  United Kingdom; Recruiting
United Kingdom, Wales
      Singleton Hospital, Swansea,  Wales,  SA2 8QA,  United Kingdom; Recruiting

Study chairs or principal investigators

Robert Charles Frederick Leonard, MD, BS, MB,  Study Chair,  Singleton Hospital   
Kirsten Murray,  Study Chair,  Scottish Cancer Therapy Network   

Study ID Numbers:  CDR0000069195; ACCOG-SCTN-BR0101; SCTN-BR0101; EU-20143; NCT00030758
Record last reviewed:  January 2004
Last Updated:  April 4, 2005
Record first received:  February 14, 2002
ClinicalTrials.gov Identifier:  NCT00030758
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08