Continuing HER-2 therapy in patients with heart dysfunction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and effectiveness of continuing HER-2 directed therapies, such as trastuzumab, pertuzumab, or trastuzumab-emtansine (T-DM1), in patients with early-stage HER-2 positive breast cancer who exhibit mild left ventricular dysfunction. Participants are randomly assigned to either continue their treatment despite heart dysfunction or follow standard guidelines that recommend discontinuation. The study aims to determine if a more aggressive treatment approach can be safely implemented while managing heart health with cardiac medications. Assessments will occur at various intervals to monitor patient outcomes over a year.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Stage I-III HER-2 positive breast cancer
2. Receiving adjuvant or neoadjuvant therapy with trastuzumab, pertuzumab, or trastuzumab-emtansine (T-DM1)
3. Evidence of left ventricular dysfunction, as defined by at least one of:

   a) LVEF \< 54% or b) LVEF ≥54% and either i) fall in LVEF of ≥15% from prior to trastuzumab, pertuzumab, or trastuzumab-emtansine (T-DM1) exposure, or ii) New York Heart Association (NYHA) class II heart failure symptoms within the past 6 months

Exclusion Criteria:

1. Current use of both angiotensin converting enzyme inhibitor (ACEI) /angiotensin receptor blocker (ARB) and beta-blocker
2. Contra-indication to both ACE-I/ARB and beta-blockers
3. NYHA class III or IV heart failure
4. LVEF \<40%
5. Systolic blood pressure \<100mmHg
6. Current or planned pregnancy or breastfeeding

Where it's running

• Hospital de Clínicas de Porto Alegre
  Porto Alegre, Rio Grande do Sul, Brazil Recruiting
• Irmandade Da Santa Casa De Misericórdia De Porto Alegre
  Porto Alegre, Rio Grande do Sul, Brazil Recruiting
• Hospital Alemão Oswaldo Cruz
  São Paulo, São Paulo, Brazil Recruiting
• Clínica de Pesquisa e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda
  São Paulo, São Paulo, Brazil Recruiting
• Juravnski Cancer Centre
  Hamitlon, Ontario, Canada Recruiting
• Ottawa Hospital Research Institute
  Ottawa, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Darryl Leong, PhD. MBBSm — McMaster University
• Study coordinator: Maha Mushtaha, BSc
• Email: maha.mushtaha@phri.ca
• Phone: 9052973479

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Dapagliflozin to prevent chemotherapy-related heart damage in breast cancer

  We will test if taking dapagliflozin 10 mg daily prevents heart and blood-vessel damage in adult women receiving anthracycline chemotherapy for breast cancer.

  Recruiting Phase 2 University Medical Centre Ljubljana · Ljubljana · NCT07245069

• Using Apple Watch data to predict heart failure outcomes

  This study is testing if data from Apple Watches can help predict heart failure problems and the chances of needing to go back to the hospital for patients with heart failure.

  Recruiting University Medical Center Goettingen · Goettigen, Lower Saxony · NCT06819618

• Exercise and fitness program for breast cancer survivors to improve heart health

  This study tests whether a special exercise and yoga program can help breast cancer survivors over 60 improve their heart health and physical fitness after treatment.

  Recruiting University of Alberta · Edmonton, Alberta · NCT06595147

• Using dapagliflozin to protect the heart in breast cancer patients receiving chemotherapy

  This study is testing if the medication dapagliflozin can help protect the hearts of breast cancer patients who are receiving chemotherapy.

  Recruiting at 3 sites Phase 3 4th Military Clinical Hospital with Polyclinic, Poland · Wroclaw, Lower Silesian Voivodeship and 2 other locations · NCT06304857

• Using Nicotinamide Riboside to Prevent Heart Problems in Breast Cancer Patients

  This study is trying to see if a supplement called nicotinamide riboside can help prevent heart problems in women with metastatic breast cancer who are receiving certain chemotherapy treatments.

  Recruiting Phase 2 University Hospital, Akershus · Lørenskog, Akershus · NCT05732051

• Comparing Aortix Device to Diuretics for Acute Heart Failure

  This study is testing whether the Aortix device can help people with acute heart failure who aren't responding to diuretics feel better compared to standard treatment.

  Recruiting at 33 sites Procyrion · Phoenix, Arizona and 49 other locations · NCT05677100

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.