SWEET: Improving outcomeS for Women diagnosed with early breast cancer through adhErence to adjuvant Endocrine Therapy

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


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:

  1. Aged 18+
  2. Female
  3. Diagnosis of ER positive invasive breast cancer, stages 1-3 and treated with curative intent
  4. Completed surgery for breast cancer
  5. Within 14 weeks of first oral Adjuvant ET prescription (tamoxifen or aromatase inhibitor) post breast cancer completion surgery


  1. Completed chemotherapy (if applicable)
  2. Able to access the internet
  3. Has access to an email address
  4. 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:


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


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