Evaluating the safety of stopping heart medications after HER2 therapy for breast cancer

Randomised Control Trial for the Safety of Withdrawal of Pharmacological Treatment for Recovered HER2 Targeted Therapy Related Cardiac Dysfunction

This study is testing if it's safe for breast cancer patients who have had heart issues from HER2 therapy to stop their heart medications after they recover.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University College, London (Academic / other)
• Locations: 2 sites (London and 1 other locations)
• Trial ID: NCT05880160 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and efficacy of withdrawing heart failure medications in patients who have recovered from cardiac dysfunction related to HER2-targeted therapy for breast cancer. It is a two-center, open-label, randomized controlled trial that will compare phased withdrawal of medications against continued treatment in non-high-risk patients. Participants will undergo cardiovascular magnetic resonance scans and complete detailed questionnaires to assess their experiences and concerns regarding treatment. The goal is to determine the optimal duration of heart failure treatment for these patients.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 who have recovered from HER2-targeted therapy-related cardiac dysfunction and are currently on heart failure medications.

Not a fit: Patients with advanced or metastatic HER2-positive breast cancer or those at high cardiovascular risk may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help reduce unnecessary long-term medication use, improving the quality of life for patients recovering from HER2 therapy-related cardiac dysfunction.

How similar studies have performed: While there have been studies on cardiac dysfunction related to cancer therapies, this specific approach of phased withdrawal in recovered patients is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Adult participants (\>18 years)
2. A prior diagnosis of human epidermal growth factor receptor 2 (HER2)- targeted therapy related cardiac dysfunction, who currently receive standard heart failure/cardioprotective medications (any combination of angiotensin-converting enzyme \[ACE\] inhibitors, angiotensin receptor blockers \[ARBs\] and/or beta-blockers).
3. Cardiac function has 'recovered'. 'Recovery' is defined as absence of heart failure symptoms with left ventricular ejection fraction (LVEF) improved to 50% or greater and N-terminal pro B-type natriuretic peptide (NTproBNP) \<125ng/L, for greater than 6 months.

Exclusion Criteria:

1. Advanced/ metastatic HER2 positive breast cancer requiring ongoing HER2 therapies or with life expectancy \<12months.
2. Patients classed as high/very high cardiovascular risk according to the International Cardio-Oncology Society (ICOS) risk stratification
3. Patients with LVEF \<50% prior to HER2-therapy initiation or on completion of anthracycline treatment
4. Patients with ongoing indications for the cardioprotective medication - ACE inhibitors, ARBs and/or beta-blockers
5. Patients with absolute contraindications to cardiovascular magnetic resonance scans (CMR).

Where this trial is running

London and 1 other locations

• St Bartholemew's Hospital — London, United Kingdom (Recruiting)
• University College London Hospital — London, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Charlotte Manisty — Ucl
• Study coordinator: Benjamin Dowsing, MBBS MSc BSc

Conditions Cardiotoxicity; HER2-positive Breast Cancer; Heart Failure; Cancer, Therapy-Related