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

Not Applicable

Completed

• Conditions: Subtopic: Breast Cancer; Disease: Breast; Topic: Cancer; Cancer

• Registration Number: ISRCTN69220108
• Lead Sponsor: Brighton & Sussex University Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-19
• Study Completion: 2016-10-27
• Last Update Posted: 17 June 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 149

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.