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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
SCHOLAR-2 Trial 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.Check my eligibility
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.See study design
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.
SCHOLAR-2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is at stage I-III and is HER2 positive.
Select...
My heart function is below normal or has worsened after cancer treatment.
SCHOLAR-2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
co-primary safety outcomes
primary efficacy outcome
Secondary outcome measures
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 • NCT0130172959%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Neurotoxicity
13%
Alanine aminotransferase increased
13%
Cough
13%
Vomting
9%
Headache
9%
Musculoskeletal pain
9%
Aspartate aminotransferase increased
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Transaminases increased
6%
Insomnia
6%
Constipation
6%
Mouth ulceration
6%
Nasopharyngitis
6%
Paronychia
6%
Flushing
6%
Face oedema
6%
Thrombocytopenia
3%
Infection
3%
Upper respiratory tract infection
3%
Completed suicide
3%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab
SCHOLAR-2 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
2014
Completed Phase 4
~5190
Pertuzumab
2014
Completed Phase 3
~7500
Trastuzumab emtansine
2010
Completed Phase 4
~2220
Find a Location
Who is running the clinical trial?
Population Health Research InstituteLead Sponsor
155 Previous Clinical Trials
679,782 Total Patients Enrolled
9 Trials studying Heart Failure
33,419 Patients Enrolled for Heart Failure
Som Mukherjee, MD MSc FRCPCPrincipal InvestigatorHamilton Health Sciences Corporation
Darryl Leong, PhD. MBBSmPrincipal InvestigatorMcMaster University
2 Previous Clinical Trials
20 Total Patients Enrolled
1 Trials studying Heart Failure
20 Patients Enrolled for Heart Failure
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your heart's pumping function is less than 40%.I am currently taking both ACE inhibitors and beta-blockers.I cannot take ACE inhibitors, ARBs, or beta-blockers due to health reasons.Your blood pressure is lower than 100mmHg when the heart is pumping.I have severe heart failure.My breast cancer is at stage I-III and is HER2 positive.My heart function is below normal or has worsened after cancer treatment.I am currently on treatment with trastuzumab, pertuzumab, or T-DM1.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the standard protocol for Trastuzumab?
"Trastuzumab is most frequently used as a breast cancer treatment, but it can also be prescribed for patients with a high risk of recurrence or as first line treatment following surgery."
Answered by AI
Are there any risks associated with Trastuzumab?
"Trastuzumab's safety was given a score of 2 out of 3 by our team at Power. While there is some evidence that the drug is safe, there is no data supporting its efficacy."
Answered by AI
How many subjects are currently enrolled in this research project?
"The listing on clinicaltrials.gov currently says that this study is open for enrollment. This trial was first posted on 7/1/2021, and the most recent update was on 6/21/2022. They are looking for 130 patients to participate at 3 different locations."
Answered by AI
What other scientific investigations have included Trastuzumab?
"As of the current moment, there are 224 different clinical trials ongoing that research Trastuzumab. Out of those, 56 are in Phase 3. The city with the most trial locations is Seattle, Washington; however, 16638 other places across the world are also running studies for this medication."
Answered by AI
Can people with the medical condition still enroll in this research project?
"This clinical trial, which was initially posted on 7/1/2021 and was most recently edited on 6/21/2022, is currently recruiting participants."
Answered by AI
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