CardiotoxicityNCT04429633
Strain vs. Left Ventricular Ejection Fraction-based Cardiotoxicity Prevention in Breast Cancer
A study testing Candesartan in people with Cardiotoxicity and Breast Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Comparing preventive effect of myocardial global longitudinal strain-based cardioprotective stragety (angiotensin receptor blocker prophylaxis) with left ventricular ejection fraction-based strategy in breast cancer patients treated with adjuvant trastuzumab. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cardiotoxicity, Breast Cancer, Prevention
- What is being tested?
- Candesartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Jul 2019to 18 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female aged ≥ 18 years
- Pathologically confirmed HER2-positive breast cancer
- Adjuvant treatment plan comprises at least 12 cycles of Trastuzumab
- Baseline echocardiogram should be performed before starting trastuzumab
- Cumulative anthracycline dose ≤ 300mg/m2
- Written informed consent to participate in the study
Who cannot join
- History of hypersensitivity or alllergic reaction to the study medication
- Metastatic breast cancer
- Treatment with angiotensin converting enzyme(ACE) inhibitor , Angiotensin receptor blocker (ARB), beta-blocking agents, or diuretics
- Patients with NCI/CTCAE grade ≥ 2 congestive heart failure, myocardial infarction, symptomatic left ventricular systolic dysfunction, heart's valve disease (≥ moderate), arrhythmias (Grade ≥ 3) < 12 months before enrollment
- Pregnancy or breast feeding
- Baseline systolic pressure < 90mmHg
- Cumulative anthracycline dose > 300mg/m2
- Serious concurrent illness
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 06351
Yeon Hee Park, MD, Ph.D, +82-2-3410-3459, yeonh.park@samsung.com
About this study
Official title: Strain-based vs. Left Ventricular Ejection Fraction-based Cardiotoxicity Prevention Strategy in Patients With Breast Cancer Who Treated With Adjuvant Trastuzumab
Comparing preventive effect of myocardial global longitudinal strain-based cardioprotective stragety (angiotensin receptor blocker prophylaxis) with left ventricular ejection fraction-based strategy in breast cancer patients treated with adjuvant trastuzumab.
Read the detailed description
Despite the left ventricular global longitudinal strain (GLS) enables early prediction of trastuzumab-related cardiomyopathy, its clinical application has been hampered due to the lack of appropriate evaluation and treatment strategies. Therefore, we aimed to evaluate the effect of early intervention strategy (GLS-based cardiotoxicity monitoring and administration of candesartan) by comparing with conventional intervention strategy (left ventricular ejection fraction-based cardiotoxicity monitoring and administration of candesartan) in breast cancer patients who treated with adjuvant trastuzumab.
- Conditions
- Cardiotoxicity, Breast Cancer, Prevention, Adjuvant, Trastuzumab
- Being tested
- Candesartan
- Medical subject headings
- Cardiotoxicity, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CandesartanDrug
If GLS decreased less than 18% or LVEF decreased to 45-50% during the treatment of adjuvant trastuzumab, start candesartan medication.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Cardiac intervention | Active comparator | Starting candesartan in patients with left ventricular ejection fraction (LVEF) between 45% and 50% by echocardiogram. Receives: Drug: Candesartan |
| Early Cardiac intervention | Active comparator | Starting candesartan in patients with decreased myocardial strain below 18% regardless of LVEF by echocardiogram. Receives: Drug: Candesartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular ejection fraction (LVEF)
Maximum change in LVEF
Measured: at months 3,6,9,12,18
Secondary outcomes (2)
Overt chemotherapy induced cardiotoxicity
LVEF < 45%, decline in LVEF by >10% to a value to 45-49%, symptomatic congestive heart failure
Measured: any time
Changes in cardiac biomarker
NT-pro BNP, cardiac troponin
Measured: at months 3,6,9,12,18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start19 Jul 2019
- Primary completion18 Jul 2022 (estimated)
- Study completion18 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiotoxicityStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeon Hee Park, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04429633
- Sponsor's protocol ID
- 2018-11-128
- Status last verified
- Jun 2020
- First submitted
- 10 Jun 2020
- Last updated
- 12 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strain-based vs. Left Ventricular Ejection Fraction-based Cardiotoxicity Prevention Strategy in Patients With Breast Cancer Who Treated With Adjuvant Trastuzumab
- ClinicalTrials.gov ID
- NCT04429633
- Acronym / sponsor ID
- 2018-11-128
- Conditions
- Cardiotoxicity, Breast Cancer, Prevention, Adjuvant, Trastuzumab
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 19 Jul 2019 (actual)
- Primary completion
- 18 Jul 2022 (estimated)
- Study completion
- 18 Jul 2023 (estimated)
- First posted
- 12 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparing preventive effect of myocardial global longitudinal strain-based cardioprotective stragety (angiotensin receptor blocker prophylaxis) with left ventricular ejection fraction-based strategy in breast cancer patients treated with adjuvant trastuzumab.
Detailed description
Despite the left ventricular global longitudinal strain (GLS) enables early prediction of trastuzumab-related cardiomyopathy, its clinical application has been hampered due to the lack of appropriate evaluation and treatment strategies. Therefore, we aimed to evaluate the effect of early intervention strategy (GLS-based cardiotoxicity monitoring and administration of candesartan) by comparing with conventional intervention strategy (left ventricular ejection fraction-based cardiotoxicity monitoring and administration of candesartan) in breast cancer patients who treated with adjuvant trastuzumab.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Cardiac intervention | Active comparator | Drug: CandesartanStarting candesartan in patients with left ventricular ejection fraction (LVEF) between 45% and 50% by echocardiogram. |
| Early Cardiac intervention | Active comparator | Drug: CandesartanStarting candesartan in patients with decreased myocardial strain below 18% regardless of LVEF by echocardiogram. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female aged ≥ 18 years
- Pathologically confirmed HER2-positive breast cancer
- Adjuvant treatment plan comprises at least 12 cycles of Trastuzumab
- Baseline echocardiogram should be performed before starting trastuzumab
- Cumulative anthracycline dose ≤ 300mg/m2
Key exclusion criteria (8 listed)
- History of hypersensitivity or alllergic reaction to the study medication
- Metastatic breast cancer
- Treatment with angiotensin converting enzyme(ACE) inhibitor , Angiotensin receptor blocker (ARB), beta-blocking agents, or diuretics
- Patients with NCI/CTCAE grade ≥ 2 congestive heart failure, myocardial infarction, symptomatic left ventricular systolic dysfunction, heart's valve disease (≥ moderate), arrhythmias (Grade ≥ 3) < 12 months before enrollment
- Pregnancy or breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CandesartanIf GLS decreased less than 18% or LVEF decreased to 45-50% during the treatment of adjuvant trastuzumab, start candesartan medication. | Drug | Conventional Cardiac intervention, Early Cardiac intervention |
Primary outcome
Left ventricular ejection fraction (LVEF)
Time frame: at months 3,6,9,12,18
Maximum change in LVEF
2 secondary outcomes
Overt chemotherapy induced cardiotoxicity
Time frame: any time
Changes in cardiac biomarker
Time frame: at months 3,6,9,12,18
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Candesartan in people with Cardiotoxicity and Breast Cancer, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yeon Hee Park, MD, PhD (+82-2-3410-3450, yeonh.park@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular ejection fraction (LVEF) (time frame: at months 3,6,9,12,18). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2020.