Topic: Cancer
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time 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