Condition category
Cancer
Date applied
07/06/2006
Date assigned
11/07/2006
Last edited
08/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Daniel Rea

ORCID ID

Contact details

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

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 measures

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

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

Sponsor information

Organisation

University of Birmingham (UK)

Sponsor details

Edgbaston
Birmingham
B15 2TT
United Kingdom

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes