A Multicentre Randomised Trial of Sequential Epirubicin and Docetaxel versus Epirubicin in Node Positive Postmenopausal Breast Cancer Patients
| ISRCTN | ISRCTN89772270 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89772270 |
| Protocol serial number | DEVA |
| Sponsor | International Collaborative Cancer Group (ICGG) (UK) |
| Funder | International Collaborative Cancer Group (UK) |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 22/10/2018
- 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
Contact information
Dr N/A N/A
Scientific
Scientific
UKCCCR Register Co-ordinator
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 | A Multicentre Randomised Trial of Sequential Epirubicin and Docetaxel versus Epirubicin in Node Positive Postmenopausal Breast Cancer Patients |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Breast cancer |
| Intervention | Arm A. Epirubicin (50 mg/m2) IV days 1 and 8, every 28 days for 6 cycles (12 doses). Arm B. Epirubicin (50 mg/m2) IV days 1 and 8 every 28 days for 3 cycles (6 doses) followed by docetaxel (100 mg/m2) IV over 1 h, day 1 every 21 days for 3 cycles. All estrogen receptor (ER) and/or progesterone receptor (PgR) positive patients must receive tamoxifen 20 mg od for 5 years. In selected centres, timing of start of tamoxifen is randomised between: Arm 1. Concurrent tamoxifen Arm 2. Sequential tamoxifen. Patients who are ER/PgR negative may take part in the tamoxifen arms at the clinicians' discretion. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Epirubicin, Docetaxel, Tamoxifen |
| Primary outcome measure(s) | Not provided at time of registration |
| Key secondary outcome measure(s) | Not provided at time of registration |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Key inclusion criteria | 1. Post-menopausal, histologically confirmed node positive breast without distant metastases 2. World Health Organisation (WHO) 1 or 2 3. No evidence of significant cardiac disease |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/08/1997 |
| Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
UKCCCR Register Co-ordinator
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 | 20/08/2011 | Yes | No | |
| Plain English results | No | Yes |
Editorial Notes
22/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
