The SWEET Trial is a multi-centre phase III, randomised control trial looking at Improving outcomes for women diagnosed with early breast cancer through adherence to adjuvant endocrine therapy. Adherence to adjuvant endocrine therapy (AET) is a significant issue with up to 50% of women reporting poor adherence by 5 years, increasing the risk of disease recurrence and mortality. The SWEET multi method research programme has designed a support package intervention called HT&Me which includes face to face or remote consultations and access to a web application specifically designed to address concerns and support patients adherence to their adjuvant endocrine therapy. The phase III trial will recruit 1460 patients, with 50% being allocated to standard care alone and the other 50% being allocated the HT&Me Support Intervention + Standard Care
Objectives:
The aim of the trial is to determine the clinical effectiveness and cost-effectiveness of the HT&Me intervention.
Primary Outcomes:
- Adherence to AET using combined self-report and prescription encashment records.
- Cancer-specific Health Related Quality of Life (HRQoL).
Secondary Outcomes:
- AET specific HRQoL
- Cost-effectiveness
Inclusion/ exclusion criteria:
Inclusion Criteria:
- Aged 18+
- Female
- Diagnosis of ER positive invasive breast cancer, stages 1-3 and treated with curative intent
- Completed surgery for breast cancer
- Within 14 weeks of first oral Adjuvant ET prescription (tamoxifen or aromatase inhibitor) post breast cancer completion surgery
- Completed chemotherapy (if applicable)
- Able to access the internet
- Has access to an email address
- Are willing to use a support package with a web-based component.
The following women will also be eligible providing they fulfil the above criteria:
- Women undergoing, or planned to receive radiotherapy,
- Women receiving anti-HER2 therapies,
- Women receiving ovarian suppression drugs,
- Women receiving, or planned to receive an adjuvant CDK4/6i (e.g. abemaciclib)
- Women who received neo-adjuvant ET
- Women who have had a previous primary breast cancer (as long as they did not have AET to treat that first cancer).
Male
Evidence of metastatic disease i.e. stage 4 disease (M1 regardless of T and N status)
Previous AET for another previous breast cancer
Have cognitive impairment sufficient to preclude participation, as judged by the clinical team
Are unable to read and understand English
Planned sample size:
1460 Participants
Total number of sites planned:
Approx. 80 Sites
Timeline:
Patient Recruitment: Jan 2024 – Dec 2025
Data collection & Patient follow-up: Feb 2024 – Jun 2027
Data Cleaning: Nov 2026 – Sep 2027
Data Analysis: Feb 2027- Oct 2027
End of Study Report: Oct 2027 – Dec 2027
Contact information and website:
Co-CI: Eila Watson
Co-CI: Linda Sharp
Trial Manager: Raegan Barrows
Trial Coordinator: Anna Mann
Email: SWEET@warwick.ac.uk