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Supporting adherence to adjuvant CDK4/6 inhibitors in women with early breast cancer (SWEET-PLUS): protocol for a multicentre UK study using qualitative and co-development methods

Lookup NU author(s): Dr Pearlin TeowORCiD, Henry Cain, Professor Adam ToddORCiD, Dr Mark Turner, Professor Linda SharpORCiD

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This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).

Abstract

© Author(s) (or their employer(s)) 2026. Re-use permitted under CC BY. Published by BMJ Group.INTRODUCTION: Breast cancer is the most common cancer in women in the UK. For women who have early-stage oestrogen-receptor positive (ER+ve) disease, daily oral adjuvant endocrine therapy reduces risk of recurrence. Recently, CDK4/6 inhibitors, a form of biological therapy, have been approved for use alongside endocrine therapy. However, trial data suggest there may be challenges with adherence to CDK4/6 inhibitors. This study aims to explore the experiences of adherence and support needs of women who have been prescribed CDK4/6 inhibitors for early ER+ve breast cancer. It will also co-develop an intervention to support women with adherence to these drugs alongside endocrine therapy through an evidence-based, theory-informed and patient-centred approach. METHODS AND ANALYSIS: The SWEET-PLUS study has three phases. Phase I uses semi-structured interviews or focus groups to explore the experiences of women with early breast cancer who have been prescribed CDK4/6 inhibitors. It will also explore their support needs and experiences of adherence. Phase II involves interviews or focus groups with healthcare professionals who support CDK4/6 inhibitor prescription and associated care to understand the existing support and unmet needs. Phase I and II findings will inform phase III, which comprises workshops and user testing interviews to co-develop an intervention to support women with adherence to CDK4/6 inhibitors alongside endocrine therapy. This will be delivered as an additional module prototype designed for future integration into the existing HT&Me intervention, which supports women with adherence to endocrine therapy.Data from phases I and II will be analysed using a framework approach-based thematic analysis. Phase III data will be analysed through content analysis. ETHICS AND DISSEMINATION: SWEET-PLUS received ethical approval from the National Health Services (NHS) Health Research Authority (Cambridge East Research Ethics Committee (25/EE/0220)). Research findings will be disseminated through peer-reviewed journal articles and via international and national conferences. Further dissemination will be guided by patient and public involvement.

Publication metadata

Author(s): Teow P, McGeagh L, Cain H, Todd A, Rehman F, Brett J, Levitt N, Turner M, Stewart S-JF, Hunt E, Terrado H, Watson E, Sharp L

Publication type: Article

Publication status: Published

Journal: BMJ open

Year: 2026

Volume: 16

Issue: 8

Online publication date: 11/08/2026

Acceptance date: 10/07/2026

Date deposited: 25/08/2026

ISSN (electronic): 2044-6055

Publisher: BMJ Group

URL: https://doi.org/10.1136/bmjopen-2026-119558

DOI: 10.1136/bmjopen-2026-119558

Data Access Statement: No data are available. Data sharing is not applicable at this stage as this manuscript describes a study protocol, and we are still in the process of data collection. Upon completion of the study, de- identified data will be made available in accordance with institutional policies, participant consent, and ethical approvals.

PubMed id: 42580839

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