PRE-DX Study

• Research type

  Research Study

• Full title

  Pre-Operative Oncotype DX testing: A decision impact study

• IRAS ID

  286636

• Contact name

  Christopher Price

• Contact email

  tnu-tr.sponsormanagement@nhs.net

• Sponsor organisation

  Newcastle upon Tyne Hospitals NHS Foundation Trust

• ISRCTN Number

  ISRCTN14337451

• Duration of Study in the UK

  2 years, 0 months, 1 days

• Research summary

  Research Summary:
  Current treatment of breast cancer patients follows a standard clinical care pathway where a core biopsy is taken during surgery. The core biopsy sample is tested using the Oncotype DX test which gives a Recurrence Score (RS) that clinicians can use to support the need for adjuvant treatments (radiotherapy and / or chemotherapy) in addition to surgery.

  This study aims to assess the impact on patient management if the Oncotype DX test is requested on a biopsy sample taken at the time of diagnosis (intervention arm) as opposed to a sample obtained during surgery (control arm). The availability of the Oncotype DX RS score earlier in the clinical care pathway may streamline the pathway, reducing time to commencement of adjuvant cancer therapy, reducing demand on health care services and improving patient experience.

  The study will recruit men and women with newly diagnosed breast cancer who are preparing to undergo treatment. The study will be opened in 20 centres across the UK, with the aim to recruit 330 patients to the study over a 8-month period.

  Summary of Results:
  The Oncotype DX® test is a prognostic and predictive genomic assay used in early oestrogen receptor-positive, HER2-negative breast cancer. The Oncotype DX® test helps doctors understand how likely a breast cancer is to come back and whether chemotherapy is likely to help. It is usually done on the tissue removed during surgery, but it can also be done earlier on the small biopsy taken at diagnosis. This study looked at whether doing the test earlier could make the treatment process smoother or reduce stress for patients.

  PRE DX trial involved 341 women with early breast cancer from 17 hospitals in the UK. All were suitable for the Oncotype test at the time of enrolment. They were randomly placed into two groups:
  • one group had the test done on their biopsy before surgery
  • the other group had the test done after surgery, which is the usual approach

  Researchers then looked at how many hospital visits patients needed, how long it took to start treatment after surgery, and how anxious or low patients felt.

  The main study outcome found that doing the test earlier did not reduce the number of hospital visits patients as had been predicted. There was a sign patients who had the test before surgery may have started their next treatment about a week sooner, but this difference wasn’t large enough to be certain.

  Whilst the overall levels of anxiety and low mood were similar between groups although amongst patients who completed the questionnaires on time, those who had the test earlier potentially showed lower anxiety and depression at follow-up.
  The test worked extremely well on the smaller biopsy samples, with a 99% success rate.

  What this means for patients: Testing the tumour earlier using the biopsy is reliable and this potentially offers some benefits, such as slightly quicker treatment planning and reduced anxiety for some people, although this is uncertain. The expected reduction in hospital visits wasn’t seen, likely because cancer services had already streamlined appointments as a result of the COVID-19 pandemic which occurred as the study was being set-up.
  

• REC name

  London - Surrey Research Ethics Committee

• REC reference

  22/LO/0421

• Date of REC Opinion

  26 Jul 2022

• REC opinion

  Further Information Favourable Opinion