Northgraves, Matthew orcid.org/0000-0001-9260-8643, Cohen, Judith, Harvey, James et al. (7 more authors) (2024) A randomised controlled trial of Pre-Operative Oncotype DX testing in early-stage breast cancer (PRE-DX study) - Study protocol. PLOS ONE. e0300339. ISSN 1932-6203
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. TRIAL REGISTRATION: The study was registered on ISRCTN (ISRCTN14337451) on the 16th August 2022.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2024 Northgraves et al. |
Keywords: | Humans,Female,Breast Neoplasms/diagnosis,Receptors, Estrogen/metabolism,Chemotherapy, Adjuvant/methods,Neoadjuvant Therapy,Adjuvants, Immunologic/therapeutic use,Gene Expression Profiling/methods,Carcinoma/drug therapy,Neoplasm Recurrence, Local/pathology,Randomized Controlled Trials as Topic |
Dates: |
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Institution: | The University of York |
Academic Units: | The University of York > Faculty of Sciences (York) > Health Sciences (York) The University of York > Faculty of Social Sciences (York) > Centre for Health Economics (York) |
Depositing User: | Pure (York) |
Date Deposited: | 19 Apr 2024 16:00 |
Last Modified: | 16 Dec 2024 00:19 |
Published Version: | https://doi.org/10.1371/journal.pone.0300339 |
Status: | Published |
Refereed: | Yes |
Identification Number: | 10.1371/journal.pone.0300339 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:211667 |
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Filename: journal.pone.0300339.pdf
Description: A randomised controlled trial of Pre-Operative Oncotype DX testing in early-stage breast cancer (PRE-DX study) – Study protocol
Licence: CC-BY 2.5