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

NCT00030758 | Unknown Phase 4

• 4 other identifiers: ACCOG-SCTN-BR0101CDR0000069195SCTN-BR0101EU-20143
• Study Type: interventional
• Target: 816
• Locations: 1 country
• Sites: 32

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.

Conditions

Breast Cancer; Neutropenia

Keywords

neutropenia; stage I breast cancer; stage II breast cancer

Outcome Measures

Primary Outcomes (2)

• Proportion of patients achieving ≥ 85% of planned dose intensity

• Proportion of patients with ≥ 1 neutropenic event

Secondary Outcomes (2)

• Dose intensity achieved

• Cost of management

Interventions

filgrastim BIOLOGICAL

pegfilgrastim BIOLOGICAL

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Anglo Celtic Cooperative Oncology Group: lead
• Scottish Cancer Therapy Network: collaborator

Study Sites (32)

City Hospital - Birmingham

Birmingham, England, B18 7QH, United Kingdom

Location

Sussex Cancer Centre at Royal Sussex County Hospital

Brighton, England, BN2 5BE, United Kingdom

Location

Cheltenham General Hospital

Cheltenham, England, GL53 7AN, United Kingdom

Location

Princess Alexandra Hospital

Essex, England, CM20 1QX, United Kingdom

Location

St. Luke's Cancer Centre at Royal Surrey County Hospital

Guildford, England, GU2 7XX, United Kingdom

Location

King George Hospital

Ilford, Essex, England, IG3 8YB, United Kingdom

Location

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Queen Elizabeth Hospital NHS Trust

London, England, SE18 4QH, United Kingdom

Location

King's College Hospital

London, England, SE5 9RS, United Kingdom

Location

St. George's Hospital

London, England, SW17 0QT, United Kingdom

Location

Christie Hospital NHS Trust

Manchester, England, M20 4BX, United Kingdom

Location

Clatterbridge Centre for Oncology NHS Trust

Merseyside, England, CH63 4JY, United Kingdom

Location

Northampton General Hospital NHS Trust

Northampton, England, NN1 5BD, United Kingdom

Location

Norfolk and Norwich University Hospital

Norwich, England, NR4 7UY, United Kingdom

Location

Nottingham City Hospital NHS Trust

Nottingham, England, NG5 1PB, United Kingdom

Location

Royal Oldham Hospital

Oldham, England, OL1 2JH, United Kingdom

Location

Peterborough Hospitals Trust

Peterborough, England, PE3 6DA, United Kingdom

Location

Berkshire Cancer Centre at Royal Berkshire Hospital

Reading, England, RG1 5AN, United Kingdom

Location

Oldchurch Hospital

Romford, England, RM7 OBE, United Kingdom

Location

Salisbury District Hospital

Salisbury, England, SP2 8BJ, United Kingdom

Location

Cancer Research Centre at Weston Park Hospital

Sheffield, England, S1O 2SJ, United Kingdom

Location

South Tyneside District Hospital

South Shields, England, NE34 0PL, United Kingdom

Location

Southampton University Hospital NHS Trust

Southampton, England, SO16 6YD, United Kingdom

Location

Sunderland Royal Hospital

Sunderland, England, SR4 7TP, United Kingdom

Location

Southend University Hospital NHS Foundation Trust

Westcliff-on-Sea, England, SS0 0RY, United Kingdom

Location

Yeovil District Hospital

Yeovil - Somerset, England, BA21 4AT, United Kingdom

Location

Ninewells Hospital and Medical School

Dundee, Scotland, DD1 9SY, United Kingdom

Location

Scottish Cancer Therapy Network

Edinburgh, Scotland, EH5 3SQ, United Kingdom

Location

West of Scotland Cancer Centre

Glasgow, Scotland, G11 6NT, United Kingdom

Location

Royal Infirmary - Castle

Glasgow, Scotland, G4 0SF, United Kingdom

Location

Raigmore Hospital

Inverness, Scotland, 1V2 3UJ, United Kingdom

Location

Singleton Hospital of the Swansea NHS Trust

Swansea, Wales, SA2 8QA, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms; Neutropenia

Interventions

Filgrastim; pegfilgrastim

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Robert C.F. Leonard, MD, BS, MB

  Charing Cross Hospital

  STUDY CHAIR

• Kirsten Murray

  Scottish Cancer Therapy Network

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Purpose: SUPPORTIVE CARE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 14, 2002
• First Posted: January 27, 2003
• Study Start: October 1, 2001
• Last Updated: August 7, 2013

Record last verified: 2007-06

Locations

GB (32)