Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

Source: ISRCTN17334319

Active, not recruiting

The ROSETA Optimisation Trial – Investigating strategies to improve medication adherence in women with early-stage breast cancer

Interventional

Phase not listed

St Luke's Hospital

Sponsor: University of Leeds

Last Updated: October 21, 2025

Notice- Information is sourced from public registries and may not reflect real-time changes at the local site.

To determine the most effective intervention package for supporting adjuvant endocrine therapy (AET) adherence at 12 months post-randomisation. This trial will also have an embedded Study Within a Trial (SWAT), a self-contained research study that has been embedded within the host trial to evaluate ways of delivering follow-up trial processes. The overall aim of the SWAT is to understand the impact of SMS pre-notification and reminder messages in the context of clinical trials using online data capture for patient-reported questionnaires.

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Treatment Category

Required Mutations

Trial Started

January 1, 2023

Last Updated by Sponsor

October 21, 2025

Estimated Completion

November 30, 2026

Contact Study

Name:Prof Sam Smith

Email:S.Smith1@leeds.ac.uk

Phone:+44 (0)113 343 0892

Name:Dr ROSETA Optimisation Trial Team

Email:ROSETA@leeds.ac.uk

Phone:None provided

Eligibility

Inclusion Criteria

1. Capacity to provide informed consent

2. Women with early stage (1-3) breast cancer according to the Tumor, Node, Metastasis (TNM)/American Joint Committee on Cancer (AJCC) staging system

Note: Women being treated for a second primary breast cancer or a breast cancer local recurrence are eligible for the trial, providing at least one of the cancers is being treated with AET, and they meet all eligibility criteria. Women with bilateral breast cancer are permitted, providing at least one breast is affected by hormone receptor-positive disease

3. Aged >= 18 years old

4. Have sufficient proficiency in English to be able to adhere to all intervention components and data collection required

5. Treated with curative intent

6. Completed their hospital-based treatment (e.g., surgery, radiotherapy and/or chemotherapy) for the current breast cancer within the last 24 months. Note: Women are still eligible for the trial if they are being treated with abemaciclib or monoclonal antibody-based therapy such as trastuzumab, kadcyla, pertuzumab, and phesgo; these medications do not have to be completed within the 24 months stipulated within this criterion.

(Updated 21/10/2025, previously: Completed their hospital-based treatment (e.g., surgery, radiotherapy and/or chemotherapy) for the current breast cancer within the last 12 months. Note: Women are still eligible for the trial if they are being treated with abemaciclib or monoclonal antibody-based therapy such as trastuzumab, kadcyla, pertuzumab, and phesgo; these medications do not have to be completed within the 12 months stipulated within this criterion).

7. Currently prescribed oral AET (tamoxifen, raloxifene, anastrozole, letrozole, exemestane)

8. Access to a mobile phone to receive SMS messages*

9. Access to a computer or smart device that can access the internet*

*Source data for these items will be either partially or completely patient self-report.

Exclusion Criteria

1. Stopped taking AET if it is clinically contraindicated according to clinical recommendation

2. Involved in a similar research trial where medication adherence is a primary outcome*,**

3. Currently attending psychotherapy/psycho-oncology/psychology/counselling services, for any clinical reason*

4. Need for treatment for a severe mental health disorder or crisis, which is likely to interfere with participation (e.g., active psychosis, bipolar disorder, significant issues with addiction or self-harm or expressing active suicidal ideation with active plans and intent*)

5. Auditory problems that would prevent the patient from participating in a telephone or video call, or hearing audio clips*

6. Taken part in the ROSETA Pilot trial.

*Source data for these items will be either partially or completely patient self-report.

**Consented to and the trial is still being delivered.

Participation in another trial will not necessarily exclude a patient from participation. CTRU should be notified of any potential conflicting trials to facilitate a review of the feasibility of co-enrolment by the CI and Trial Management Group (TMG). The review will consider the methodological impact and participant burden.

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Design Details

AllocationRandomized controlled 2⁴ factorial optimisation trial with an embedded Study Within a Trial

Intervention ModelRandomised controlled trial

MaskingN/A

Number to Enroll512

Arms & Interventions

Arms

Interventions

No interventions available.

Outcome Measures

Primary Outcome Measures

N/AN/A

To determine the most effective intervention package for supporting adjuvant endocrine therapy (AET) adherence by using the Domains of Subjective Extent of Nonadherence (DOSE-Nonadherence) measure – collected at 12 months post-randomisation

Secondary Outcome Measures

N/AN/A

Cost of SWAT intervention per participant retained at one-month.

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Trial Sites

This study has 38 trial sites

St Luke's Hospital

Bradford, Yorkshire and the Humber, GB

Recruiting

Bradford, Yorkshire and the Humber, BD5 0NA GB

St Luke's Hospital

Recruiting

York, Yorkshire and the Humber, YO31 8HE GB

York Hospital

Recruiting

Hull, Yorkshire and the Humber, HU3 2JZ GB

Hull Royal Infirmary

Recruiting

Birmingham, West Midlands, B15 2GW GB

Queen Elizabeth Hospital Birmingham

Recruiting

Woolwich, Greater London, SE18 4QH GB

Queen Elizabeth Hospital

Recruiting

London, Greater London, E9 6SR GB

Homerton University Hospital

Recruiting

Gateshead, North East, NE9 6SX GB

Queen Elizabeth Hospital Gateshead

Recruiting

Harrow, Greater London, HA1 3UJ GB

Northwick Park Hospital

Recruiting

Wythenshawe, North West, M23 9LT GB

Wythenshawe Hospital

Recruiting

Cottingham, Yorkshire and the Humber, HU16 5JQ GB

Castle Hill Hospital

Recruiting

Bradford, Yorkshire and the Humber, BD9 6RJ GB

Bradford Royal Infirmary

Recruiting

Liverpool, North West, L9 7AL GB

Aintree University Hospital

Recruiting

London, Greater London, EC1A 7BE GB

St Bartholomew's Hospital

Recruiting

Middlesborough, North East, TS4 3BW GB

The James Cook University Hospital

Recruiting

Thornton Heath, Greater London, CR7 7YE GB

Croydon University Hospital

Recruiting

Torquay, South West, TQ2 7AA GB

Torbay Hospital

Recruiting

Milton Keynes, South East, MK6 5LD GB

Milton Keynes University Hospital

Recruiting

Watford, East of England, WD18 0HB GB

Watford General Hospital

Recruiting

Lewisham, Greater London, SE13 6LH GB

University Hospital Lewisham

Recruiting

Wakefield, Yorkshire and the Humber, WF1 4DG GB

Pinderfields General Hospital

Recruiting

Prescot, North West, L35 5DR GB

Whiston Hospital

Recruiting

Southall, Greater London, UB1 3HW GB

Ealing Hospital

Recruiting

Liverpool, North West, L69 3GA GB

Royal Liverpool University Hospital

Recruiting

Leeds, LS9 7TF GB

Leeds Teaching Hospitals NHS Trust - Lead centre

Recruiting

Chesterfield, East Midlands, S44 5BL GB

Chesterfield Royal Hospital

Recruiting

Westcliff on sea, East of England, SS0 0RY GB

Southend University Hospital

Recruiting

Redhill, South East, RH1 5RH GB

East Surrey Hospital

Recruiting

Bolton, North West, BL4 0JR GB

Royal Bolton Hospital

Recruiting

Warrington, WA2 8DB GB

St Marys Hospital

Recruiting

Harlow, East of England, CM20 1QX GB

Princess Alexandra Hospital

Recruiting

Ashton-under-lyne, OL6 9RW GB

Tameside and Glossop Integrated Care NHS Foundation Trust

Recruiting

St. Helens, WA9 3DA GB

St Helens Hospital

Recruiting

Pontefract, WF8 1PL GB

Pontefract Hospital

Recruiting

Dewsbury, WF13 4HS GB

Dewsbury & District Hospital

Recruiting

Redhill, RH1 5RH GB

Surrey and Sussex Healthcare NHS Trust

Recruiting

North Shields, NE29 8NH GB

North Tyneside Hospital

Recruiting

Ashington, NE63 9JJ GB

Wansbeck Hospital

Recruiting

Hexham, NE46 1QJ GB

Hexham General Hospital

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