Pre-operative Oncotype Dx testing - A Decision Impact Study (Pre-Dx)

Study Design:

Randomised Controlled Trial

Disease Area:

Breast Cancer


Genomic Health, Inc

Chief Investigator:

Dr Henry Cain, Royal Victoria Infirmary, Newcastle Upon Tyne




Currently, your cancer treatment plan follows a standard pathway that uses biopsy samples taken during surgery to support your doctors to be make the best decisions about how you should be treated going forwards. These biopsy samples are tested using a test called Oncotype DX.

Oncotype Dx is a prognostic and predictive genomic assay, validated and approved for use in early Oestrogen receptor positive (ER+) breast cancer to guide adjuvant treatment choices (chemotherapy, radiotherapy or endocrine therapy).

This multi-centre prospective randomised controlled trial (RCT) aims to see whether testing the biopsy sample taken at the time of diagnosis (rather than at surgery) can help doctors to plan your cancer treatment.

What we plan to do

We will invite 330 patients newly diagnosed with breast cancer to participate in the study from 20 different hospitals around the UK. 110 patients will be randomised to the standard arm (biopsy test done at surgery) and 220 patients to the intervention arm (biopsy test done at diagnosis).

There will be no change to other standard pre-operative investigations or clinics.In both arms of the study, the interpretation of the test results and future treatment recommendations will be at the discretion of the multidisciplinary team and treating clinicians according to national guidelines.

Patients will be asked to complete questionnaires about their mental wellbeing and health service utilisation at various point during the study recruitment and follow up period.


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Trial progress

In set-up


Hull Health Trials Unit
3rd Floor AMB
University of Hull