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Breast CancerPhase 2NCT05806138

A Study of Vericiguat in People With Breast Cancer and Cancer Therapy-Related Cardiac Dysfunction

A Phase 2 study testing Vericiguat and Optimal medical therapy in people with Breast Cancer and Cardiac Dysfunction, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to find out if adding vericiguat to standard treatment for cancer therapy related cardiac dysfunction (CTRCD) is more effective than standard treatment alone. The addition of vericiguat to the usual treatment could help improve cardiac function, but it could also cause side effects. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer, Cardiac Dysfunction
What is being tested?
Vericiguat and Optimal medical therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
17 Jul 2023to 17 Jul 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Age ≥ 18 years
  • Biopsy proven breast cancer (stage I-IV)
  • Cancer treatment related cardiac dysfunction (CTRCD), established by an absolute decrease in LVEF ≥ 10% from baseline/pre-treatment to < 53% and attributable to prior cardiotoxic cancer treatment, per the clinical investigator.
  • Able to complete an acceptable baseline CPET, in the absence of high-risk ECG findings or other inappropriate response to exercise as determined by the PI, as defined by any of the following criteria:
  • Achieving a plateau oxygen consumption, concurrent with an increase in power output;
  • A respiratory exchange ratio ≥ 1.00;
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  • Attainment of maximal predicted heart rate, as defined by a peak heart rate within 10bpm of the age predicted maximal heart rate (220 - Age[years]); or if on a beta-blocker, 164 - (age * 0.7)
  • Volitional exhaustion, as measured by a rating of perceived exertion (RPE) ≥ 18 on the BORG scale.
  • Willing to use highly effective contraceptive measures if of child-bearing potential or if the patient's sexual partner is a woman of child-earing potential while receiving study drug and for 30 days after the last dose of study drug:
  • Female subjects should be using highly effective contraceptive measures, and must have a negative pregnancy test (within 6 months prior to study enrollment) and not be breast-feeding prior to start of dosing if of child-bearing potential or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:
  • Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments
  • Women under 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the postmenopausal range for the institution
  • Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy, but not tubal ligation.
  • Male subjects should be willing to use barrier contraception °Willing and able to comply with the requirements of the protocol.

Who cannot join

  • Systolic blood pressure < 90 mmHg
  • Concurrent or anticipated use of a long-acting nitrate or NO donor (e.g., nitroglycerin, isosorbide dinitrate, isosorbide 5-mononitrate, pentaerythritol tetranitrate, nicorandil or transdermal NTG patch, or molsidomine).
  • Concurrent or anticipated use of a phosphodiesterase inhibitor (e.g., vardenafil, tadalafil, or sildenafil).
  • Cardiac comorbidity, including any of the following:
  • Hypertrophic cardiomyopathy, restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac sarcoidosis, or amyloid cardiomyopathy
  • Uncontrolled arrhythmia
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  • Uncorrected congenital cardiac disease
  • Acute coronary syndrome, percutaneous coronary intervention, or coronary artery bypass graft surgery within 3 months prior to randomization.
  • Symptomatic carotid stenosis, or transient ischemic attack (TIA) or stroke within 3 months prior to randomization.
  • Cardiac transplantation
  • Valvular heart disease requiring surgery or intervention
  • Non-cardiac comorbidity, including any of the following:
  • eGFR < 15ml/min/1.73m^2 (based upon CKD-EPI, Cockroft-Gault, etc.)
  • Severe hepatic insufficiency (e.g., Child-Pugh C)
  • Severe pulmonary disease, such as requiring continuous home oxygen or interstitial lung disease
  • Other medical disorder or condition that in the opinion of the investigator would impair the subject's ability to participate or complete the study
  • Subjects must not have any of the following absolute contraindications to cardiopulmonary exercise testing:
  • Acute myocardial infarction (within 30 days of any planned study procedures)
  • Unstable angina
  • Uncontrolled arrhythmias causing symptoms or hemodynamic compromise,
  • Symptomatic severe aortic stenosis
  • Recurrent syncope
  • Active endocarditis
  • Acute myocarditis or pericarditis
  • Acute pulmonary embolus or pulmonary infarction (within 3 months of any planned study procedures)
  • Thrombosis of lower extremities (within 3 months of any planned study procedures)
  • Suspected dissecting aneurysm
  • Uncontrolled asthma
  • Pulmonary edema
  • Room air desaturation at rest ≤85%
  • Respiratory failure
  • Acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis)
  • Mental impairment leading to inability to cooperate.
  • Current alcohol and/or drug abuse
  • Any other condition or intercurrent illness (e.g., symptomatic weight-bearing bone metastases or limited life expectancy < 6-9 months) that, in the opinion of the investigator, makes the participant a poor candidate for the trial

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New York, 10065

Other trials in United States

About this study

Official title: A Randomized Controlled Trial of the Soluble Guanylate Cyclase Stimulator Vericiguat in Patients With Breast Cancer and Cancer Therapy-Related Cardiac Dysfunction (ELEVATE)

The purpose of this study is to find out if adding vericiguat to standard treatment for cancer therapy related cardiac dysfunction (CTRCD) is more effective than standard treatment alone. The addition of vericiguat to the usual treatment could help improve cardiac function, but it could also cause side effects. This study will help researchers find out whether this different treatment is better, the same as, or worse than the usual approach.

Being tested
Vericiguat, Optimal medical therapy
Keywords
Vericiguat, Cancer Therapy-Related Cardiac Dysfunction (CTRCD), 23-050
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VericiguatDrug

    A starting dose of vericiguat 2.5 mg will be administered in-clinic at the Day 1 visit. Titration visits will occur on Days 14 and 28, with dose escalation to 5 mg and 10 mg.

  • Optimal medical therapyOther

    All subjects will be followed by a cardiologist throughout the study period and will receive optimal medical therapy for cardiomyopathy/heart failure following the ACCF/AHA and ESC Guidelines for the Management of Heart Failure recommendations, applied individually at the discretion of the treating investigator and in line with individual tolerability. This includes medications such as ßblockers, angiotensin converting enzyme inhibitors(ACEI), angiotensin receptor/neprilysin inhibitor (ARNI), angiotensin receptor blockers (ARB), and mineralocorticoid antagonists

Study groups in NCT05806138
Study groupRoleWhat they receive
Vericiguat plus optimal medical therapyExperimentalFor patients randomized to vericiguat, a starting dose of 2.5mg will be initiated at the randomization visit. At pre-specified titration visits, subjects will be up-titrated to vericiguat 5mg and then to the target dose of vericiguat 10mg using titration criteria based on mean systolic blood pressure and evaluation for clinical symptoms. Vericiguat will be administered in the background of optimal medical therapy for cardiomyopathy/heart failure.
Receives: Drug: Vericiguat
Optimal medical therapyActive comparatorFor patients randomized to the control group, optimal medical therapy for cardiomyopathy/heart failure will be instituted throughout the study period.
Receives: Other: Optimal medical therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change in CRF (measured by VO2peak)

    For the primary analysis, intervention effect will be evaluated by comparing differences in mean VO2peak changes from baseline to month 6 between the investigational and control groups using the analysis of covariance approach (ANCOVA).

    Measured: up to 6 months

Secondary outcomes (1)

  1. CRF response rate

    assessed by the number of participants with a change in VO2peak ≥ 1.32 ml O2 • kg-1 • min-1 (technical error of CRF measurement) from baseline to month 6. A change in VO2peak ≥ 1.32 ml O2 • kg-1 • min-1 will be considered a response, whereas a change in VO2peak < 1.32 ml O2 • kg-1 • min-1 will be considered a non-response.

    Measured: up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2023
  2. Study start17 Jul 2023
  3. Primary completion17 Jul 2028 (estimated)
  4. Study completion17 Jul 2028 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a single center, open-label, randomized controlled trial of vericiguat in adult patients with breast cancer and Cancer Therapy-Related Cardiac Dysfunction (CTRCD).
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05806138
Sponsor's protocol ID
23-050
Status last verified
Jul 2026
First submitted
28 Mar 2023
Last updated
3 Aug 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vericiguat and Optimal medical therapy in people with Breast Cancer and Cardiac Dysfunction, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

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 14 inclusion and 35 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: under way, not looking for participants, as of the sponsor's last update on 3 Aug 2026. 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 United States. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in CRF (measured by VO2peak) (time frame: up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05806138.

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 3 Aug 2026.

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