Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
08/11/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

DEVA

Study information

Scientific title

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 measures

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

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

Sponsor information

Organisation

International Collaborative Cancer Group (ICGG) (UK)

Sponsor details

Medical Oncology
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom

Sponsor type

Research organisation

Website

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

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21768453

Publication citations

  1. 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.

Additional files

Editorial Notes