Condition category
Cancer
Date applied
01/07/2001
Date assigned
01/07/2001
Last edited
08/10/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Contact information

Type

Scientific

Primary contact

Ms Lisa Lloyd

ORCID ID

Contact details

Institute of Cancer Research Clinical Trials and Statistics Unit (ICR-CTSU)
Section of Epidemiology
Brookes Lawley Building
Cotswold Road
Sutton
Surrey
SM2 5NG
United Kingdom
+44 (0)208 722 4063
lisa.lloyd@icr.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00079248

Protocol/serial number

N/A

Study information

Scientific title

Acronym

HRT

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

Treatment

Patient information sheet

Condition

Breast

Intervention

1. HRT
2. No HRT (advice about non-hormonal alternatives)

Trial was closed early (December 2005) due to poor recruitment.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/08/2003

Overall trial end date

01/08/2006

Reason abandoned

Participant recruitment issues

Eligibility

Participant inclusion criteria

1. Patients must have had proven stage I/II breast cancer with no clinical evidence of recurrence since diagnosis
2. Have been given a patient information pack
3. Be postmenopausal as defined by:
a. Having been amenorrhoeic for at least 6 months (including women who have had radiation or chemical induced ovarian suppression) irrespective of menopausal status at time of diagnosis
b. Having received surgical bilateral oophorectomy
c. Be experiencing vasomotor symptoms (i.e. hot flushes or night sweats) with or without vaginal dryness.

All such women are eligible irrespective of current/previous treatment for breast cancer.

Participant type

Patient

Age group

Not Specified

Gender

Female

Target number of participants

Modified 25/02/2010: 3000

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/08/2003

Recruitment end date

01/08/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Cancer Research Clinical Trials and Statistics Unit (ICR-CTSU)
Sutton, Surrey
SM2 5NG
United Kingdom

Sponsor information

Organisation

Individual Sponsor (UK)

Sponsor details

C/o Mr Nigel Sacks
The Royal Marsden NHS Trust
London
SM2 5NG
United Kingdom
+44 (0) 20 8722 4373
Claire.Dawson@icr.ac.uk

Sponsor type

Research organisation

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

Publication citations

Additional files

Editorial Notes