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Monoclonal Antibodies

HER-2 Directed Therapy for Heart Failure (SCHOLAR-2 Trial)

Phase 2

Recruiting

Led By Som Mukherjee, MD MSc FRCPC

Research Sponsored by Population Health Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Stage I-III HER-2 positive breast cancer

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

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year

Awards & highlights

No Placebo-Only Group

Summary

This trial is important because it will help us understand whether it is safe and effective to continue trastuzumab, pertuzumab or trastuzumab-emtansine despite mild, minimally symptomatic or asymptomatic systolic left ventricular dysfunction.

Who is the study for?

This trial is for patients with early stage HER-2 positive breast cancer who are undergoing treatment with trastuzumab, pertuzumab, or T-DM1 and have mild heart issues. They must not be pregnant, breastfeeding, or have severe heart failure or very low blood pressure.

What is being tested?

The study tests if it's safe to continue using HER-2 targeted therapies like trastuzumab, pertuzumab, and T-DM1 in patients with some heart dysfunction versus stopping them as current guidelines suggest.

What are the potential side effects?

HER-2 therapies can cause heart problems leading to symptoms like shortness of breath and fatigue. The trial will monitor for worsening of these conditions while continuing the cancer treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast cancer is at stage I-III and is HER2 positive.

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My heart function is below normal or has worsened after cancer treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking both ACE inhibitors and beta-blockers.

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I cannot take ACE inhibitors, ARBs, or beta-blockers due to health reasons.

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I have severe heart failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

co-primary safety outcomes

primary efficacy outcome

Secondary study objectives

measures the composite of NYHA class III or IV heart failure, breast cancer relapse, or all-cause mortality.

Side effects data

From 2014 Phase 4 trial • 32 Patients • NCT01301729

59%

Leukopenia

56%

Neutropenia

34%

Hypoaesthesia

31%

Agranulocytosis

22%

Alopecia

22%

Asthenia

19%

Pyrexia

16%

Nail disorder

16%

Oedema peripheral

16%

Diarrhoea

16%

Hypophagia

13%

Alanine aminotransferase increased

13%

Neurotoxicity

13%

Cough

13%

Vomting

Musculoskeletal pain

Aspartate aminotransferase increased

Headache

Chest discomfort

Rash

Pigmentation disorder

Nausea

Bone marrow failure

Anaemia

Transaminases increased

Insomnia

Constipation

Mouth ulceration

Nasopharyngitis

Paronychia

Flushing

Face oedema

Thrombocytopenia

Infection

Upper respiratory tract infection

Completed suicide

Cataract

100%

80%

60%

40%

20%

Study treatment Arm

Trastuzumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention GroupExperimental Treatment3 Interventions

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.

Group II: Control GroupActive Control3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Trastuzumab emtansine

2010

Completed Phase 4

~2290

Trastuzumab

2014

Completed Phase 4

~5190