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
Non randomised study
Trial setting
Hospitals
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
Other
Phase
Drug names
Primary outcome measure
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.
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
27/10/2016
Reason abandoned (if study stopped)
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
Total final enrolment
149
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
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
Basic results (scientific)
Publication list