Randomised Phase III trial of navelbine/epirubicin versus navelbine/mitozantrone versus adriamycin/cyclophosphamide as pre-operative chemotherapy in patients with more than or equal to 3 cm diameter early breast cancer

ISRCTN	ISRCTN72868621
DOI	https://doi.org/10.1186/ISRCTN72868621
ClinicalTrials.gov number	NCT00004237
Secondary identifying numbers	TOPIC2

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Randomised Phase III trial of navelbine/epirubicin versus navelbine/mitozantrone versus adriamycin/cyclophosphamide as pre-operative chemotherapy in patients with more than or equal to 3 cm diameter early breast cancer
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Breast cancer
Intervention	Treatment Arms: In the ratio of 1:1 - Navelbine 25 mg/m^2 intravenous (iv) bolus day one, epirubicin 60 mg/m^2 iv bolus day one repeating at three week intervals for six courses Adriamycin 60 mg/m^2 iv bolus day one, cyclophosphamide 600 mg/m^2 iv bolus day one repeating at three week intervals for six courses
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase III
Drug / device / biological / vaccine name(s)	Navelbine/epirubicin, navelbine/mitozantrone and adriamycin/cyclophosphamide.
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/1998
Completion date	31/12/2002

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	Not provided at time of registration
Key inclusion criteria	1. Histologically proven breast cancer (incisional specimen or tru-cut biopsy) 2. Upper age limit 70 years 3. Potentially operable primary breast cancer more than or equal to 3 cm in diameter (maximum). (Patients with tumours more than or equal to 2 cm may also be included where chemotherapy is deemed appropriate and the patients would otherwise require radical surgery) 4. White Blood Cell (WBC) count more than 3.0 x 10^9/l, platelets more than 150 x 10^9/l 5. No evidence of metastatic disease (routine chest X-ray [CXR], biochemistry). Other investigations, e.g. bone scan, liver ultrasound, are only required for symptoms and/or abnormal biochemistry 6. World Health Organisation (WHO) performance Status zero to one 7. Normal liver function (Billirubin, transaminases, creatinine less than or equal to 1.5 x upper limit of normal value) 8. Written informed consent
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/1998
Date of final enrolment	31/12/2002

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

The Institute of Cancer Research (UK)
Government

123 Old Brompton Road
London
SW7 3RP
United Kingdom

Website	http://www.icr.ac.uk
"ROR"	https://ror.org/043jzw605

Research organisation

Institute of Cancer Research (UK)
Government organisation / National government

Alternative name(s): Institute of Cancer Research - CIHR, CIHR Institute of Cancer Research, L'Institut du cancer, Institut du cancer, ICR - CIHR, ICR, IC
Location: Canada

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2005		Yes	No

06/06/2019: Internal review.