A randomised trial of epirubicin and cyclophosphamide versus epirubicin and paclitaxel in the treatment of women with metastatic breast cancer
| ISRCTN | ISRCTN75147488 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75147488 |
| ClinicalTrials.gov (NCT) | NCT00002953 |
| Protocol serial number | AB01 |
| Sponsor | Medical Research Council (MRC) (UK) |
| Funder | Medical Research Council (UK) |
- Submission date
- 28/02/2001
- Registration date
- 28/02/2001
- Last edited
- 07/10/2009
- 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 of protocol
Not provided at time of registration
Contact information
Dr Barbara Uscinska
Scientific
Scientific
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To compare epirubicin and paclitaxel versus epirubicin and cyclophosphamide in metastatic breast cancer |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cancer |
| Intervention | Epirubicin and paclitaxel/epirubicin and cyclophosphamide |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | epirubicin and cyclophosphamide versus epirubicin and paclitaxel |
| Primary outcome measure(s) |
Progression free survival. |
| Key secondary outcome measure(s) |
Overall survival, response, toxicity, quality of life (Fact-B Quality of Life, Questionnaire); and health economics (Cost and Resource Use Questionnaire). |
| Completion date | 05/11/1999 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Target sample size at registration | 700 |
| Key inclusion criteria | 1. Metastatic breast cancer previously untreated except in adjuvant setting 2. Exposure to anthracyclines limited 3. Treatment free interval more than 6 months 4. Normal ejection fraction |
| Key exclusion criteria | History of cardiac disease |
| Date of first enrolment | 01/12/1996 |
| Date of final enrolment | 05/11/1999 |
Locations
Countries of recruitment
- United Kingdom
- England
- South Africa
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 20/11/2005 | Yes | No |
