Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
BR2017
Study information
Scientific title
A multicentre phase II feasibility study of accelerated chemotherapy - sequential epirubicin followed by intravenous cyclophosphamide, methotrexate and fluorouracil - using pegfilgrastim for women with early stage breast cancer
Acronym
NEAT-A
Study hypothesis
To explore the feasibility and toxicity of accelerated epirubicin, cyclophosphamide, methotrexate and fluorouracil (E-CMF) chemotherapy, using single doses of pegfilgrastim to reduce the interval between chemotherapy cycles, in a cohort of patients who would normally be treated with conventional E-CMF.
Ethics approval
Approved by West Hertfordshire Local Research Ethics Committee on 01/11/2004, reference number: 04/Q0203/27
Study design
Phase II non-randomised feasibility study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Breast cancer
Intervention
Patients should be treated according to the following schedule:
D1 Epirubicin 100 mg/m^2 intravenous (i.v) administration
D2 Pegfilgrastim 6 mg single dose subcutaneous administration (s.c.)
Repeated every 14 days for four cycles.
Then either:
Classical i.v. CMF (option A)
D1 Cyclophosphamide 600 mg/m2 i.v.
Methotrexate 40 mg/m^2 i.v.
5-Fluorouracil 600 mg/m^2 i.v.
D8 Cyclophosphamide 600 mg/m^2 i.v.
Methotrexate 40 mg/m^2 i.v.
5-Fluorouracil 600 mg/m^2 i.v.
D9 Pegfilgrastim 6 mg single dose s.c.
Repeated every 21 days for 4 cycles. Folinic acid (15 mg orally (p.o.) six-hourly times six doses commencing 24 h post methotrexate) should be administered with all cycles of CMF
Intervention type
Drug
Phase
Phase II
Drug names
Epirubicin, cyclophosphamide, methotrexate, fluorouracil, pegfilgrastim, folinic acid
Primary outcome measure
Delivered dose intensity
Secondary outcome measures
Toxicity and safety
Overall trial start date
04/03/2005
Overall trial end date
01/07/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Histological diagnosis of invasive early breast cancer with complete excision following surgery
2. No evidence of metastatic disease
3. Clear indication for adjuvant chemotherapy based on clinical and histopathological features
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
5. Clinically assessed as fit to undergo E-CMF chemotherapy at full dose
a. Haematological parameters within normal range for institution
b. Liver function tests (aspartate aminotransferase [AST] or alanine aminotransferase [ALT]) ≤1.5 upper limit of normal (ULN)
c. Adequate renal function with creatinine clearance >50 ml/min (calculated according to Cockcroft formula)
6. No previous chemotherapy or radiotherapy
7. Aged 18 years and over
8. Non-pregnant and non-lactating, with no intention of pregnancy during chemotherapy, and prepared to adopt adequate contraceptive measures if pre-menopausal and sexually active
9. Written informed consent obtained
10. No concomitant medical or psychiatric problems that might prevent completion of treatment
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
80
Participant exclusion criteria
1. Significant history of cardiac disease (prior myocardial infarction, angina, uncontrolled hypertension)
2. Any co-morbidity significantly adding to risks associated with cytotoxic chemotherapy for instance: severe chronic obstructive pulmonary disease, poorly controlled diabetes etc
3. Recent exposure to immunosuppressive drugs including oral corticosteroid
4. Inability to comply with protocol requirements
Recruitment start date
04/03/2005
Recruitment end date
01/07/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Cancer Research UK Clinical Trials Unit
Birmingham
B15 2TT
United Kingdom
Funders
Funder type
Industry
Funder name
Educational grants from Amgen UK and Pfizer UK
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list