Safety of Continuing HER-2 Directed Therapy in Overt Left Ventricular Dysfunction

Trastuzumab is an important treatment for HER 2 positive breast cancer. But trastuzumab can cause injury to the heart, and this is one of the main reasons it cannot be administered as planned. Heart injury can often be successfully treated using cardiac medications. The objectives of SCHOLAR-2 are to evaluate whether is it safe and effective to continue trastuzumab, pertuzumab or trastuzumab-emtansine (T-DM1) in patients with early stage HER-2 positive breast cancer despite mild, minimally symptomatic or asymptomatic systolic left ventricular dysfunction as compared with a guideline-driven app

Trial Details

NCT ID
NCT04680442
Phase
PHASE2
Sponsor
Population Health Research Institute
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • Trastuzumab
  • Pertuzumab
  • Trastuzumab emtansine
Locations (sample)
  • Porto Alegre, Rio Grande do Sul, Brazil|-30.03283,-51.23019
  • Porto Alegre, Rio Grande do Sul, Brazil|-30.03283,-51.23019
  • São Paulo, São Paulo, Brazil|-23.5475,-46.63611
  • São Paulo, São Paulo, Brazil|-23.5475,-46.63611
  • Hamitlon, Ontario, Canada

Key Eligibility Criteria

  • Stage I-III HER-2 positive breast cancer
  • Receiving adjuvant or neoadjuvant therapy with trastuzumab, pertuzumab, or trastuzumab-emtansine (T-DM1)
  • 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,…

For full eligibility, visit ClinicalTrials.gov.

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