Status:
RECRUITING
Safety of Continuing HER-2 Directed Therapy in Overt Left Ventricular Dysfunction
Lead Sponsor:
Population Health Research Institute
Conditions:
Breast Cancer
Heart Failure
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
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 i...
Detailed Description
SCHOLAR-2 is a Phase II open-label randomized controlled trial with blinded outcome event ascertainment with a target sample size of 130. Control Group Recommendations for continuing or holding trast...
Eligibility Criteria
Inclusion
- 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, or ii) New York Heart Association (NYHA) class II heart failure symptoms within the past 6 months
Exclusion
- Current use of both angiotensin converting enzyme inhibitor (ACEI) /angiotensin receptor blocker (ARB) and beta-blocker
- Contra-indication to both ACE-I/ARB and beta-blockers
- NYHA class III or IV heart failure
- LVEF \<40%
- Systolic blood pressure \<100mmHg
- Current or planned pregnancy or breastfeeding
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT04680442
Start Date
July 1 2021
End Date
June 30 2026
Last Update
April 6 2025
Active Locations (8)
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1
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035903 / 90410000
2
Irmandade Da Santa Casa De Misericórdia De Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90050-170
3
Hospital Alemão Oswaldo Cruz
São Paulo, São Paulo, Brazil, 01327-903
4
Clínica de Pesquisa e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda
São Paulo, São Paulo, Brazil, 1317000