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

ISRCTN ISRCTN69220108
DOI https://doi.org/10.1186/ISRCTN69220108
Secondary identifying numbers 19287
Submission date
19/08/2015
Registration date
19/08/2015
Last edited
23/05/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-to-help-decide-if-women-with-breast-cancer-should-have-further-treatment-endopredict

Contact information

Mrs Amy Arbon
Public

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

Study information

Study designNon-randomised; Interventional; Design type: Diagnosis, Treatment
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleThe 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
Study acronymEndoPredict
Study objectivesBreast 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(s)NRES Committee South Central - Oxford C, 07/04/2015, ref: 15/SC/0090
Health condition(s) or problem(s) studiedTopic: Cancer; Subtopic: Breast Cancer; Disease: Breast
InterventionEligible 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 typeOther
Primary outcome measureChange in use of chemotherapy, 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 measuresRecording 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 study start date21/07/2015
Completion date27/10/2016

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participantsPlanned Sample Size: 151; UK Sample Size: 151
Total final enrolment149
Key inclusion criteria1. 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
Key exclusion criteria1. Patients unwilling to accept adjuvant chemotherapy
2. Patients unable to give full informed consent
Date of first enrolment28/07/2015
Date of final enrolment01/05/2016

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centres

Royal Sussex County Hospital (lead centre)
Eastern Road
Brighton
BN2 5BE
United Kingdom
Western Sussex Hospitals NHS Foundation Trust
Lyndhurst Rd
Worthing, West Sussex
BN11 2DH
United Kingdom
Surrey & Sussex Healthcare NHS
East Surrey Hospital
Canada Ave
Redhill
Surrey
RH1 5RH
United Kingdom
Dartford and Gravesham NHS Trust
Darent Valley Hospital
Darenth Wood Road
Dartford
Kent
DA2 8DA
United Kingdom
East Sussex Healthcare NHS Trust
King's Dr
Eastbourne
East Sussex
BN21 2UD
United Kingdom
Maidstone & Tunbridge Wells NHS Trust
Tunbridge Wells Hospital
Tonbridge Road
Tunbridge Wells
Kent
TN2 4QJ
United Kingdom
East Kent Hospitals University NHS Foundation Trust
Kent
CT1 3NG
United Kingdom
Frimley Park Hospital
Portsmouth Road
Frimley
Surrey
GU16 7UJ
United Kingdom
Royal Surrey County Hospital
Egerton Road
Guildford
Surrey
GU2 7XX
United Kingdom

Sponsor information

Brighton & Sussex University Hospitals NHS Trust
Hospital/treatment centre

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

Funders

Funder type

Industry

Myriad Genetics Inc

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Plain English results 23/05/2019 No Yes
HRA research summary 28/06/2023 No No

Editorial Notes

23/05/2019: The following changes were made to the trial record:
1. Added CRUK link to results (plain English).
2. The total final enrolment was added.
04/05/2017: The overall trial end date was changed from 01/05/2016 to 27/10/2016.

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