Clinical trial NCT00030758: Filgrastim or Pegfilgrastim in Preventing Neutropenia in Women Receiving Chemotherapy Following Surgery for Breast Cancer
Official title: G-CSF (Filgrastim) or Pegfilgrastim Secondary Prophylaxis In The Adjuvant Chemotherapy Of Early Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Breast Cancer
Neutropenia
Keywords: neutropenia
stage I breast cancer
stage II breast cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: Scottish Cancer Therapy Network
First posted: 2003-01-27
Enrollment: 816
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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)

Primary outcomes:
measure: Proportion of patients achieving ≥ 85% of planned dose intensity
measure: Proportion of patients with ≥ 1 neutropenic event
Secondary outcomes:
measure: Dose intensity achieved
measure: Cost of management
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: City Hospital - Birmingham
state: England
city: Brighton
country: United Kingdom
facility: Sussex Cancer Centre at Royal Sussex County Hospital
state: England
city: Cheltenham
country: United Kingdom
facility: Cheltenham General Hospital
state: England
city: Essex
country: United Kingdom
facility: Princess Alexandra Hospital
state: England
city: Guildford
country: United Kingdom
facility: St. Luke's Cancer Centre at Royal Surrey County Hospital
state: England
city: Ilford, Essex
country: United Kingdom
facility: King George Hospital
state: England
city: Leeds
country: United Kingdom
facility: Leeds Cancer Centre at St. James's University Hospital
state: England
city: London
country: United Kingdom
facility: Queen Elizabeth Hospital NHS Trust
state: England
city: London
country: United Kingdom
facility: King's College Hospital
state: England
city: London
country: United Kingdom
facility: St. George's Hospital
state: England
city: Manchester
country: United Kingdom
facility: Christie Hospital NHS Trust
state: England
city: Merseyside
country: United Kingdom
facility: Clatterbridge Centre for Oncology NHS Trust
state: England
city: Northampton
country: United Kingdom
facility: Northampton General Hospital NHS Trust
state: England
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital
state: England
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital NHS Trust
state: England
city: Oldham
country: United Kingdom
facility: Royal Oldham Hospital
state: England
city: Peterborough
country: United Kingdom
facility: Peterborough Hospitals Trust
state: England
city: Reading
country: United Kingdom
facility: Berkshire Cancer Centre at Royal Berkshire Hospital
state: England
city: Romford
country: United Kingdom
facility: Oldchurch Hospital
state: England
city: Salisbury
country: United Kingdom
facility: Salisbury District Hospital
state: England
city: Sheffield
country: United Kingdom
facility: Cancer Research Centre at Weston Park Hospital
state: England
city: South Shields
country: United Kingdom
facility: South Tyneside District Hospital
state: England
city: Southampton
country: United Kingdom
facility: Southampton University Hospital NHS Trust
state: England
city: Sunderland
country: United Kingdom
facility: Sunderland Royal Hospital
state: England
city: Westcliff-On-Sea
country: United Kingdom
facility: Southend University Hospital NHS Foundation Trust
state: England
city: Yeovil - Somerset
country: United Kingdom
facility: Yeovil District Hospital
state: England
city: Dundee
country: United Kingdom
facility: Ninewells Hospital and Medical School
state: Scotland
city: Edinburgh
country: United Kingdom
facility: Scottish Cancer Therapy Network
state: Scotland
city: Glasgow
country: United Kingdom
facility: West of Scotland Cancer Centre
state: Scotland
city: Glasgow
country: United Kingdom
facility: Royal Infirmary - Castle
state: Scotland
city: Inverness
country: United Kingdom
facility: Raigmore Hospital
state: Scotland
city: Swansea
country: United Kingdom
facility: Singleton Hospital of the Swansea NHS Trust
state: Wales
Study officials:
affiliation: Charing Cross Hospital
name: Robert C.F. Leonard, MD, BS, MB
role: STUDY_CHAIR
affiliation: Scottish Cancer Therapy Network
name: Kirsten Murray
role: STUDY_CHAIR
References: