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
Submission date
19/08/2002
Registration date
19/08/2002
Last edited
06/06/2019
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

Not provided at time of registration

Contact information

Dr - -
Scientific

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleRandomised 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 hypothesisNot provided at time of registration
Ethics approval(s)Not provided at time of registration
ConditionBreast cancer
InterventionTreatment 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 typeDrug
Pharmaceutical study type(s)
PhasePhase III
Drug / device / biological / vaccine name(s)Navelbine/epirubicin, navelbine/mitozantrone and adriamycin/cyclophosphamide.
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/1998
Overall study end date31/12/2002

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participantsNot provided at time of registration
Participant inclusion criteria1. 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 exclusion criteriaNot provided at time of registration
Recruitment start date01/01/1998
Recruitment end date31/12/2002

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

The Institute of Cancer Research (UK)
Government

123 Old Brompton Road
London
SW7 3RP
United Kingdom

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

Funders

Funder type

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

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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

Editorial Notes

06/06/2019: Internal review.

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