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 |
| Protocol serial number | 19287 |
| Sponsor | Brighton & Sussex University Hospitals NHS Trust |
| Funder | Myriad Genetics Inc |
- 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
Contact information
Mrs Amy Arbon
Public
Public
Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised; Interventional; Design type: Diagnosis, Treatment |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| 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 |
| Study acronym | EndoPredict |
| Study objectives | 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(s) | NRES Committee South Central - Oxford C, 07/04/2015, ref: 15/SC/0090 |
| Health condition(s) or problem(s) studied | 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 | Other |
| Primary outcome measure(s) |
Change 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. |
| Key secondary outcome measure(s) |
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. |
| Completion date | 27/10/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 151 |
| Total final enrolment | 149 |
| Key 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 |
| Key exclusion criteria | 1. Patients unwilling to accept adjuvant chemotherapy 2. Patients unable to give full informed consent |
| Date of first enrolment | 28/07/2015 |
| Date of final enrolment | 01/05/2016 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
Royal Sussex County Hospital (lead centre)
Eastern Road
Brighton
BN2 5BE
United Kingdom
Brighton
BN2 5BE
United Kingdom
Western Sussex Hospitals NHS Foundation Trust
Lyndhurst Rd
Worthing, West Sussex
BN11 2DH
United Kingdom
Worthing, West Sussex
BN11 2DH
United Kingdom
Surrey & Sussex Healthcare NHS
East Surrey Hospital
Canada Ave
Redhill
Surrey
RH1 5RH
United Kingdom
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
Darenth Wood Road
Dartford
Kent
DA2 8DA
United Kingdom
East Sussex Healthcare NHS Trust
King's Dr
Eastbourne
East Sussex
BN21 2UD
United Kingdom
Eastbourne
East Sussex
BN21 2UD
United Kingdom
Maidstone & Tunbridge Wells NHS Trust
Tunbridge Wells Hospital
Tonbridge Road
Tunbridge Wells
Kent
TN2 4QJ
United Kingdom
Tonbridge Road
Tunbridge Wells
Kent
TN2 4QJ
United Kingdom
East Kent Hospitals University NHS Foundation Trust
Kent
CT1 3NG
United Kingdom
CT1 3NG
United Kingdom
Frimley Park Hospital
Portsmouth Road
Frimley
Surrey
GU16 7UJ
United Kingdom
Frimley
Surrey
GU16 7UJ
United Kingdom
Royal Surrey County Hospital
Egerton Road
Guildford
Surrey
GU2 7XX
United Kingdom
Guildford
Surrey
GU2 7XX
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | 23/05/2019 | No | Yes |
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.
