Plain English Summary
Study website
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
DEVA
Study information
Scientific title
A Multicentre Randomised Trial of Sequential Epirubicin and Docetaxel versus Epirubicin in Node Positive Postmenopausal Breast Cancer Patients
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study type
Not Specified
Patient information sheet
Condition
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
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
Epirubicin, Docetaxel, Tamoxifen
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall study start date
01/08/1997
Overall study end date
31/12/2005
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Not Specified
Sex
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/08/1997
Recruitment end date
31/12/2005
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Funders
Funder type
Research organisation
Funder name
International Collaborative Cancer Group (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Plain English results | No | Yes | |||
| Results article | results | 20/08/2011 | Yes | No |