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A randomised controlled trial of Pre-Operative Oncotype DX testing in early-stage breast cancer (PRE-DX study) - Study protocol

Northgraves, Matthew; Cohen, Judith; Harvey, James; Huang, Chao; Palmieri, Carlo; Pinder, Sarah; Roy, Pankaj; Reynia, Sarah; Soares, Marta; Cain, Henry

Authors

James Harvey

Carlo Palmieri

Sarah Pinder

Pankaj Roy

Sarah Reynia

Marta Soares

Henry Cain



Abstract

Background
The Oncotype DX® Breast Recurrence Score assay can guide recommendations made to patients with oestrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer regarding post-surgery adjuvant therapy. Standard practice is to order the test in the post-operative setting on a specimen from the excised invasive carcinoma. However, it has been shown to be technically possible to perform the test on the diagnostic core biopsy. By testing the diagnostic core biopsy in the pre-operative setting, the wait for excised invasive carcinoma Recurrence Score results could be reduced allowing patients to be more accurately counselled regarding their treatment pathway sooner with any adjuvant treatment recommendations expedited. This would allow for more efficient streaming of follow up appointments. The aim of this study is to compare the impact on the patient treatment pathway of performing the Oncotype DX® test on the diagnostic core biopsy pre-operatively (intervention) as opposed to the excised invasive carcinoma (control).
Methods and analysis
This parallel group randomised controlled trial aims to recruit 330 newly diagnosed patients with grade 2 or grade 3, ER+, HER2-, invasive intermediate risk early-stage breast cancer. Participants will be randomised 2:1 to the preoperative testing of the diagnostic core biopsy compared to the post-operative testing of the excision specimen. The primary endpoint is number of clinical touchpoints between treating team and patient from initial approach until offer and prescription of the first adjuvant treatment. Secondary endpoints include time from diagnosis to offer and prescription of the first adjuvant treatment, patient-reported anxiety scores and health cost impact analysis collected at baseline, following the post-operative clinic and following the offer of adjuvant treatment, and number of alterations in treatment sequence from original planned surgical treatment to neoadjuvant therapy.

Citation

Northgraves, M., Cohen, J., Harvey, J., Huang, C., Palmieri, C., Pinder, S., Roy, P., Reynia, S., Soares, M., & Cain, H. (2024). A randomised controlled trial of Pre-Operative Oncotype DX testing in early-stage breast cancer (PRE-DX study) - Study protocol. PLoS ONE, 19(3), Article e0300339. https://doi.org/10.1371/journal.pone.0300339

Journal Article Type Article
Acceptance Date Mar 7, 2024
Publication Date Mar 1, 2024
Deposit Date Mar 8, 2024
Publicly Available Date Apr 15, 2024
Journal PLoS ONE
Print ISSN 1932-6203
Electronic ISSN 1932-6203
Publisher Public Library of Science
Peer Reviewed Peer Reviewed
Volume 19
Issue 3
Article Number e0300339
DOI https://doi.org/10.1371/journal.pone.0300339
Public URL https://hull-repository.worktribe.com/output/4576920

Files

Published paper (1.4 Mb)
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Publisher Licence URL
http://creativecommons.org/licenses/by/4.0

Copyright Statement
© 2024 Northgraves et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.




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