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
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
-
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.