Oncotype DXBreast Recurrence Score® assay guides recommendations made to patients with ER+/HER2- breast cancer regarding post-surgery adjuvant therapy. Standard practice is to perform this on the surgical excision specimen following surgical treatment, but it is technically possible to perform the Oncotype DX® test on the diagnostic core biopsy (DCB). Testing the DCB should eliminate the wait for surgical excision specimen Recurrence Score® (RS) results, and patients could be more accurately counselled at an earlier time-point regarding their treatment pathway and adjuvant treatments expedited allowing more efficient streaming of follow up appointments.
PRE-DX is a UK based multi-centre, parallel group randomised controlled trial (2:1; Intervention:Control) which opened to recruitment in October 2022. The trial is comparing the impact on the patient pathway of performing the Oncotype DX test on the DCB pre-operatively (intervention) as opposed to the surgical excision specimen (control). Patients aged ≥ 18 year of age with ER+, HER2- tumours (grade 2 ≥20mm or grade 3 of any size and axilla N0 or N1 of any size / grade), with surgery planned as the primary definitive treatment and fit for chemotherapy are eligible. Patients are ineligible if they are already participating in another clinical trial. The primary endpoint is number of clinical touchpoints between treating team and patient from initial approach to offer and prescription of the first adjuvant treatment. Secondary endpoints include time from diagnosis to offer and prescription of the first adjuvant treatment, alteration in treatment sequence from original planned treatment, patient-reported anxiety scores, health cost impact analysis, and DCB failure rate for RS result. The study will recruit 330 patients from up to 25 participating National Health Service centres with recruitment expected to end in July / August 2023.
ISRCTN14337451.
Jess Hoag - Exact Sciences Purva Singla - Exact Sciences Gebra Cuyun Carter - Exact Sciences.
Newcastle upon Tyne Hospitals NHS Foundation Trust.
Genomic Health.
J. Cohen: Financial Interests, Personal and Institutional, Research Grant: Exact Sciences, AstraZeneca, ImaginAb. P. Roy: Financial Interests, Personal, Advisory Board: Exact Sciences. S. Reynia: Financial Interests, Personal and Institutional, Leadership Role: Exact Sciences; Financial Interests, Personal and Institutional, Stocks/Shares: Exact Sciences. H.J. Cain: Financial Interests, Personal, Advisory Board: Roche Medical, Exact Sciences, Baxter, Lilly, AstraZeneca, Merck & Co., Veracity; Financial Interests, Personal, Invited Speaker: Roche Medical, Exact Sciences, Baxter, Lilly, AstraZeneca, Merck & Co.; Financial Interests, Personal, Research Grant: Roche Medical; Financial Interests, Personal and Institutional, Research Grant: Exact Sciences. All other authors have declared no conflicts of interest.