Plain English Summary
Trial website
Additional identifiers
EudraCT 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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial 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
Phase
Not Specified
Drug names
Epirubicin, Docetaxel, Tamoxifen
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/08/1997
Overall trial 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
Patient
Age group
Not Specified
Gender
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
United Kingdom
Trial 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
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21768453
Publication citations
-
Results
Coombes RC, Bliss JM, Espie M, Erdkamp F, Wals J, Tres A, Marty M, Coleman RE, Tubiana-Mathieu N, den Boer MO, Wardley A, Kilburn LS, Cooper D, Thomas MW, Reise JA, Wilkinson K, Hupperets P, Randomized, phase III trial of sequential epirubicin and docetaxel versus epirubicin alone in postmenopausal patients with node-positive breast cancer., J. Clin. Oncol., 2011, 29, 24, 3247-3254, doi: 10.1200/JCO.2010.32.7254.