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.

Authors

Pearlin Teow, Lucy McGeagh, Henry Cain, Adam Todd, Farah Rehman, Jo Brett, Nicky Levitt, Mark Turner, Sarah-Jane F Stewart, Emma Hunt, Hazeline Terrado, Eila Watson, Linda Sharp

Published in

BMJ open. Volume 16. Issue 8. Pages e119558. Aug 11, 2026. Epub Aug 11, 2026.

Abstract

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.
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.
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.

PMID:
42580839
Bibliographic data and abstract were imported from PubMed on 12 Aug 2026.

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