Safety of Continuing HER-2 Directed Therapy in Overt Left Ventricular Dysfunction (SCHOLAR-2)
Breast Cancer, Heart Failure
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion 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, or ii) New York Heart Association (NYHA) class II heart failure symptoms within the past 6 months
Exclusion Criteria:
- 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
Sites / Locations
- Hospital de Clínicas de Porto AlegreRecruiting
- Irmandade Da Santa Casa De Misericórdia De Porto AlegreRecruiting
- Hospital Alemão Oswaldo CruzRecruiting
- Clínica de Pesquisa e Centro de Estudos em Oncologia Ginecológica e Mamária LtdaRecruiting
- Juravnski Cancer CentreRecruiting
- Ottawa Hospital Research InstituteRecruiting
- Toronto General Hospital, University Health NetworkRecruiting
- E.Meshalkin National medical research center of the Ministry of Health of the Russian Federation
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Control Group
Intervention Group
Recommendations for continuing or holding trastuzumab, pertuzumab, or trastuzumab-emtansine (T-DM1) for the control group are guided by an adaptation of the 2008 Canadian recommendations.
The intervention group will continue to receive trastuzumab, pertuzumab, or trastuzumab-emtansine (T-DM1) in the setting of asymptomatic decline in LVEF up to an LVEF of 40% as outlined in the criteria listed in Table 3. For reasons of practicality, in the intervention group, the first dose of trastuzumab, pertuzumab, or trastuzumab-emtansine (T-DM1) after randomization can be administered up to 3 weeks late. This will allow time for the participant to be reviewed by a cardiologist and to receive ACE-I/angiotensin receptor blocker and/or beta-blocker, and for dose titration.