OncoMatch/Clinical Trials/NCT04680442
Safety of Continuing HER-2 Directed Therapy in Overt Left Ventricular Dysfunction
Is NCT04680442 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Trastuzumab and Pertuzumab for breast cancer.
Treatment: Trastuzumab · Pertuzumab · Trastuzumab emtansine — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) amplification (HER-2 positive)
HER-2 positive breast cancer
Disease stage
Required: Stage I, II, III
Prior therapy
Must have received: HER2-targeted therapy (trastuzumab, pertuzumab, trastuzumab emtansine) — adjuvant or neoadjuvant
Receiving adjuvant or neoadjuvant therapy with trastuzumab, pertuzumab, or trastuzumab-emtansine (T-DM1)
Lab requirements
Cardiac function
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) NYHA class II heart failure symptoms within the past 6 months
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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT04680442 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received HER2-targeted therapy.
Does this trial require ERBB2?
Yes, ERBB2 amplification is a required biomarker for enrollment.
What disease stage is eligible?
Stage I or II or III is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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