Condition category
Cancer
Date applied
19/08/2015
Date assigned
19/08/2015
Last edited
19/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Public

Primary contact

Mrs Amy Arbon

ORCID ID

Contact details

Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

19287

Study information

Scientific title

The use of a prognostic tool (EndoPredict®) to inform adjuvant chemotherapy decision in low to medium risk oestrogen receptor positive, Her­-2 negative early breast cancer: feasibility, acceptability and economic impact in multicentre UK NHS practice

Acronym

EndoPredict

Study hypothesis

Breast cancer is common and causes a large burden of suffering. The majority of women with breast cancer are ER positive, HER2 negative. Currently, a number of factors are used to stratify patients as being either high risk or low risk for distant metastases developing within 10 years of surgery. If patients fall within the low risk group, they are treated with endocrine therapy and if they are highrisk, they are treated with endocrine therapy and chemotherapy. Patients who fall into the intermediate risk category present a challenge to clinicians and in many cases where there is uncertainty, chemotherapy may be used as a precautionary measure, resulting in possible overuse of chemotherapy in patients. Chemotherapy has a significant side effect profile and it is both resource intensive and high cost. EndoPredict is a multigene test for predicting likelihood of distant metastases in patients with ER positive, HER2-negative breast cancer. The tool combines gene expression and tumour prognostic indicators to identify a subgroup of women who have low risk of distant recurrence of disease. This information can therefore help clinicians identify women who would not benefit from chemotherapy and save them the unnecessary side effects of treatment. This trial will take place in high patient volume NHS breast oncology clinics in South-East England. The study will look at the impact of the EndoPredict tool on clinical decision making by doctors, by comparing chemotherapy decisions before and after information from the EndoPredict is added. It also aims to explore patient attitudes surrounding risk and satisfaction when it is used. Cost analysis will be performed to assess if there is longer term financial benefit with its use.

Ethics approval

NRES Committee South Central - Oxford C, 07/04/2015, ref: 15/SC/0090

Study design

Non-randomised; Interventional; Design type: Diagnosis, Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Topic: Cancer; Subtopic: Breast Cancer; Disease: Breast

Intervention

Eligible patients will be discussed post-operatively in the relevant local breast multidisciplinary meeting. Those who are identified as eligible will ideally be given the patient information sheet by a member of the breast team at the post-surgical review, or sent a covering letter and patient information sheet in the post prior to first oncology consultation., or given the patient information sheet by a member of the breast team at the post-surgical review. If they give their consent to the study, their breast surgery tissue will be sent to a central lab to undergo the EndoPredict test. At the first consultation, patients will be invited to complete the 3 following questionnaires: (Decision conflict scale (DCS) and the STAI trait/state anxiety). Patient and oncologist meet again within 2 weeks with EndoPredict test results available. Additional information from this test is shared and discussed and a joint treatment decision made about adjuvant chemotherapy. Patients then complete questionnaires (Decision conflict scale (DCS) and the STAI state form. Decision and chemotherapy regimen is documented in CRF.

Intervention type

Drug

Phase

Drug names

Primary outcome measures

Change in use of chemotheropy, measuring any change in treatment decision after receiving the EndoPredict test results, by the patient and by the clinician, recorded on a case report form.

Secondary outcome measures

Recording psychosocial outcomes which may influence decision making, recorded on STAI trait, STAI state, and DCS licensed questionnaires. Economic analysis of difference in chemotherapy use.

Overall trial start date

21/07/2015

Overall trial end date

01/05/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women over 18 years of age with first presentation of early Oestrogen Receptor +ve and HER­2
2. Negative breast cancer with all known disease surgically removed
3. Women who have an unclear decision regarding chemotherapy based on standard prognostic criteria
4. Performance status and general health sufficient in the judgement of the treating oncologist to manage adjuvant chemotherapy
5. Ability to understand verbal and written English

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 151; UK Sample Size: 151

Participant exclusion criteria

1. Patients unwilling to accept adjuvant chemotherapy
2. Patients unable to give full informed consent

Recruitment start date

28/07/2015

Recruitment end date

01/05/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Sussex County Hospital (lead centre)
Eastern Road
Brighton
BN2 5BE
United Kingdom

Trial participating centre

Western Sussex Hospitals NHS Foundation Trust
Lyndhurst Rd
Worthing, West Sussex
BN11 2DH
United Kingdom

Trial participating centre

Surrey & Sussex Healthcare NHS
East Surrey Hospital Canada Ave Redhill
Surrey
RH1 5RH
United Kingdom

Trial participating centre

Dartford and Gravesham NHS Trust
Darent Valley Hospital Darenth Wood Road Dartford
Kent
DA2 8DA
United Kingdom

Trial participating centre

East Sussex Healthcare NHS Trust
King's Dr Eastbourne
East Sussex
BN21 2UD
United Kingdom

Trial participating centre

Maidstone & Tunbridge Wells NHS Trust
Tunbridge Wells Hospital Tonbridge Road Tunbridge Wells
Kent
TN2 4QJ
United Kingdom

Trial participating centre

East Kent Hospitals University NHS Foundation Trust
Kent
CT1 3NG
United Kingdom

Trial participating centre

Frimley Park Hospital
Portsmouth Road Frimley
Surrey
GU16 7UJ
United Kingdom

Trial participating centre

Royal Surrey County Hospital
Egerton Road Guildford
Surrey
GU2 7XX
United Kingdom

Sponsor information

Organisation

Brighton & Sussex University Hospitals NHS Trust

Sponsor details

CIRU
Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Myriad Genetics Inc

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

Publication citations

Additional files

Editorial Notes