Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
15/10/2012
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 - -

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00004237

Protocol/serial number

TOPIC2

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Phase III

Drug names

Navelbine/epirubicin, navelbine/mitozantrone and adriamycin/cyclophosphamide.

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1998

Overall trial end date

31/12/2002

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/1998

Recruitment end date

31/12/2002

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

The Institute of Cancer Research (UK)

Sponsor details

123 Old Brompton Road
London
SW7 3RP
United Kingdom

Sponsor type

Government

Website

http://www.icr.ac.uk

Funders

Funder type

Research organisation

Funder name

Institute of Cancer Research (UK)

Alternative name(s)

l'Institut du cancer, Institut du Cancer, ICR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Canada

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

1. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15946977

Publication citations

  1. Results

    Chua S, Smith IE, A'Hern RP, Coombes GA, Hickish TF, Robinson AC, Laing RW, O'Brien ME, Ebbs SR, Hong A, Wardley A, Mughal T, Verrill M, Dubois D, Bliss JM, , Neoadjuvant vinorelbine/epirubicin (VE) versus standard adriamycin/cyclophosphamide (AC) in operable breast cancer: analysis of response and tolerability in a randomised phase III trial (TOPIC 2)., Ann. Oncol., 2005, 16, 9, 1435-1441, doi: 10.1093/annonc/mdi276.

Additional files

Editorial Notes