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
approach of withholding or discontinuing trastuzumab, pertuzumab or trastuzumab-emtansine
(T-DM1).
In SCHOLAR-2, we will compare two thresholds of withholding or discontinuing
trastuzumab/pertuzumab/trastuzumab-emtansine: a threshold that is currently advocated for
by existing treatment practice guidelines versus a more aggressive threshold that allows
trastuzumab/pertuzumab/trastuzumab-emtansine to continue at lower levels of LVEF than
currently supported by guideline documents.
Additional locations may be listed on ClinicalTrials.gov for NCT04680442.
Locations matching your search criteria
United States
California
Los Angeles
UCLA / Jonsson Comprehensive Cancer CenterStatus: Active
Contact: Ladda Douangvila-Chhan
Phone: 310-794-4797
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 trastuzumab, pertuzumab, or
trastuzumab-emtansine (T-DM1) for the control group are guided by an adaptation of the
2008 Canadian recommendations.
Intervention Group 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.
Study assessments will occur:
1. 3 weeks after randomization
2. 6 weeks after randomization
3. Follow-up at every 3 months thereafter until 12 months after the last dose of
trastuzumab, pertuzumab, or trastuzumab-emtansine (T-DM1)
Lead OrganizationPopulation Health Research Institute
Principal InvestigatorDarryl Leong
