Condition category
Cancer
Date applied
01/07/2001
Date assigned
01/07/2001
Last edited
01/02/2012
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 - -

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

B29(Scot)

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Breast

Intervention

Both arms receive Epirubicin 100 mg/m^2 iv every 3 weeks for a maximum of eight doses. At each cycle patients also receive a 6-day course of capsules either Quinidine 250 mg or placebo.

Intervention type

Drug

Phase

Not Specified

Drug names

epirubicin, quinidine

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1988

Overall trial end date

01/09/1992

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histologically proven metastatic or locally advanced disease
2. Measurable or evaluable disease
3. World Health Organisation (WHO) Performance status at least 2
4. Haemoglobin ≥10 g%
5. White Blood Count (WBC) >4.0 x10^9/l
6. Platelets ≥100 x 10^9/l
7. Bilirubin within normal range
8. Not currently receiving hormone treatment
9. No prior chemotherapy for advanced 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

01/01/1988

Recruitment end date

01/09/1992

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Cancer Research UK (CRUK) (UK)

Sponsor details

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
+44 (0)207 317 5186
kate.law@cancer.org.uk

Sponsor type

Charity

Website

http://www.cancer.org.uk

Funders

Funder type

Charity

Funder name

Cancer Research UK

Alternative name(s)

CRUK

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

1994 results in http://www.ncbi.nlm.nih.gov/pubmed/8083699

Publication citations

  1. Results

    Wishart GC, Bissett D, Paul J, Jodrell D, Harnett A, Habeshaw T, Kerr DJ, Macham MA, Soukop M, Leonard RC, Quinidine as a resistance modulator of epirubicin in advanced breast cancer: mature results of a placebo-controlled randomized trial., J. Clin. Oncol., 1994, 12, 9, 1771-1777.

Additional files

Editorial Notes