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

ISRCTN	ISRCTN07812773
DOI	https://doi.org/10.1186/ISRCTN07812773
Secondary identifying numbers	BR2017

Submission date: 07/06/2006
Registration date: 11/07/2006
Last edited: 03/01/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Daniel Rea
Scientific

Cancer Research UK Clinical Trials Unit
Institute for Cancer Studies
The University of Birmingham
Birmingham
B15 2TT
United Kingdom

Study information

Study design	Phase II non-randomised feasibility study
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study acronym	NEAT-A
Study objectives	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(s)	Approved by West Hertfordshire Local Research Ethics Committee on 01/11/2004, reference number: 04/Q0203/27
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Phase II
Drug / device / biological / vaccine name(s)	Epirubicin, cyclophosphamide, methotrexate, fluorouracil, pegfilgrastim, folinic acid
Primary outcome measure	Delivered dose intensity
Secondary outcome measures	Toxicity and safety
Overall study start date	04/03/2005
Completion date	01/07/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	80
Total final enrolment	44
Key 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
Key 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
Date of first enrolment	04/03/2005
Date of final enrolment	01/07/2006

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Cancer Research UK Clinical Trials Unit

Birmingham
B15 2TT
United Kingdom

Sponsor information

University of Birmingham (UK)
University/education

Edgbaston
Birmingham
B15 2TT
England
United Kingdom

"ROR"	https://ror.org/03angcq70

Funders

Funder type

Industry

Educational grants from Amgen UK and Pfizer UK

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Abstract results	results	20/06/2007	03/01/2020	No	No

Editorial Notes

03/01/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
18/10/2017: No publications found, verifying study status with principal investigator