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 |
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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
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
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 hypothesis | Not provided at time of registration |
Ethics approval(s) | Not provided at time of registration |
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 |
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 |
Overall study end date | 31/12/2002 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Female |
Target number of participants | Not provided at time of registration |
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 exclusion criteria | Not provided at time of registration |
Recruitment start date | 01/01/1998 |
Recruitment end date | 31/12/2002 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
The Institute of Cancer Research (UK)
Government
Government
123 Old Brompton Road
London
SW7 3RP
United Kingdom
Website | http://www.icr.ac.uk |
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https://ror.org/043jzw605 |
Funders
Funder type
Research organisation
Institute of Cancer Research (UK)
Government organisation / National government
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 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 |
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.