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A randomised placebo-controlled trial of epirubicin and quinidine in patients with advanced breast cancer
Source of recordUK Trials
ISRCTNISRCTN23196537
Date ISRCTN assigned01/07/2001
Local reference number(s)B29(Scot)
Public titleA randomised placebo-controlled trial of epirubicin and quinidine in patients with advanced breast cancer
Scientific title
AcronymN/A
Disease/condition/study domainBreast
Study hypothesisNot provided at time of registration
Design/methodologyRandomised placebo controlled trial
Research ethics reviewNot provided at time of registration
Countries of trialUnited Kingdom
Participants - inclusion criteria1. 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
Participants - exclusion criteriaNot provided at time of registration
Patient information material
Anticipated start date01/01/1988
Anticipated end date01/09/1992
Status of trialCompleted
Target number of participantsNot provided at time of registration
InterventionsBoth 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.
Primary outcome measure(s)Not provided at time of registration
Secondary outcome measure(s)Not provided at time of registration
Sources of fundingCancer Research UK
Sponsor nameCancer Research UK
Sponsor detailsPO Box 123
Lincoln's Inn Fields
London
United Kingdom
WC2A 3PX
Sponsor telephone+44 (0)20 7317 5186
Sponsor fax+44 (0)20 7487 4302
Sponsor emailkate.law@cancer.org.uk
Sponsor websitehttp://www.cancer.org.uk
Contact nameDr - -
Contact detailsUKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA
Contact telephone+44 (0) 20 7670 4723
Contact fax+44 (0) 20 7670 4818
Contact emailregister@ctu.mrc.ac.uk
More informationFor more up-to-date information please go to the ISRCTN link below.
Link to record in ISRCTN RegisterISRCTN23196537
Date last extracted from ISRCTN register17/04/2008
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