SWEET

Overview

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).

Exclusion criteria

• 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