Condition category
Cancer
Date applied
28/02/2001
Date assigned
28/02/2001
Last edited
07/10/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Barbara Uscinska

ORCID ID

Contact details

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00002953

Protocol/serial number

AB01

Study information

Scientific title

Acronym

Study hypothesis

To compare epirubicin and paclitaxel versus epirubicin and cyclophosphamide in metastatic breast cancer

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

Cancer

Intervention

Epirubicin and paclitaxel/epirubicin and cyclophosphamide

Intervention type

Drug

Phase

Not Specified

Drug names

epirubicin and cyclophosphamide versus epirubicin and paclitaxel

Primary outcome measures

Progression free survival.

Secondary outcome measures

Overall survival, response, toxicity, quality of life (Fact-B Quality of Life, Questionnaire); and health economics (Cost and Resource Use Questionnaire).

Overall trial start date

01/12/1996

Overall trial end date

05/11/1999

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Female

Target number of participants

700

Participant exclusion criteria

History of cardiac disease

Recruitment start date

01/12/1996

Recruitment end date

05/11/1999

Locations

Countries of recruitment

South Africa, United Kingdom

Trial participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16293863

Publication citations

  1. Results

    Langley RE, Carmichael J, Jones AL, Cameron DA, Qian W, Uscinska B, Howell A, Parmar M, Phase III trial of epirubicin plus paclitaxel compared with epirubicin plus cyclophosphamide as first-line chemotherapy for metastatic breast cancer: United Kingdom National Cancer Research Institute trial AB01., J. Clin. Oncol., 2005, 23, 33, 8322-8330, doi: 10.1200/JCO.2005.01.1817.

Additional files

Editorial Notes