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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN69220108
Enrollment
151
Registered
2015-08-19
Start date
2015-07-28
Completion date
Unknown
Last updated
2019-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Cancer

Interventions

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

Sponsors

Brighton & Sussex University Hospitals NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

United Kingdom

Contacts

Public ContactAmy Arbon

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 26, 2026