Clinical trial · Interventional
Safety of Continuing CHemotherapy in Overt Left Ventricular Dysfunction Using Antibodies to HER-2
A Phase I Clinical Study to Examine the Safety of Continued Treatment With Trastuzumab for Individuals With Overt Left Ventricular Dysfunction
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 aim of SCHOLAR is to evaluate whether it is safe to continue trastuzumab in individuals with mild or moderate cardiac injury, while treating them with appropriate cardiac medications. In this way the investigators hope to be able to optimise the delivery of a treatment to patients with breast cancer that has proven survival benefits, especially when administered for a full 12-month course.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Heart Failure | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| standard-of-care treatments for LV impairment | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Heart failure
- description
- Treat the HER-2 positive breast cancer patients experiencing mild or moderate LV impairment by standard-of-care treatments for LV impairment using ACE-I and beta-blockers
- interventionNames
- Drug: standard-of-care treatments for LV impairment
Primary outcomes (2)
- measure
- Safety outcomes
- timeFrame
- one year
- description
- The primary safety outcome will be the development of cardiac dose-limiting toxicity (cDLT), defined as the occurrence of any of a)cardiovascular death, b)left ventricular ejection fraction (LVEF) \<40% together with any heart failure symptoms, or c) LVEF \<35%
- measure
- Efficacy outcomes
- timeFrame
- one year
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Stage I-III HER-2 positive breast cancer * Receiving adjuvant therapy with trastuzumab * Provide informed consent * Exhibit LV dysfunction as evidenced by either * LVEF between 40% and the lower limit for normal (i.e. \<54% in women or \< 52% in men18), or * LVEF within normal limits (i.e. ≥54% in women or ≥52% in men) and NYHA class II heart failure symptoms within the past year, or * A fall in LVEF of ≥15% from baseline Exclusion Criteria: Patients will not be eligible for SCHOLAR if they have any of the following: * NYHA class III or IV heart failure * Systolic blood pressure \<90mmHg * Current use of both ACE-I/angiotensin receptor blocker and beta-blocker * Contra-indication to both ACE-I/angiotensin receptor blocker and beta-blocker
References
Publications (1)
- DERIVEDLeong DP, Cosman T, Alhussein MM, Kumar Tyagi N, Karampatos S, Barron CC, Wright D, Tandon V, Magloire P, Joseph P, Conen D, Devereaux PJ, Ellis PM, Mukherjee SD, Dhesy-Thind S. Safety of Continuing Trastuzumab Despite Mild Cardiotoxicity: A Phase I Trial. JACC CardioOncol. 2019 Jul 17;1(1):1-10. doi: 10.1016/j.jaccao.2019.06.004. eCollection 2019 Sep. PMID 34396157