A Phase 2 Study of Vericiguat in People With Breast Cancer and Cancer Treatment-Related Heart Problems

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Full Title

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

Purpose

Some breast cancer treatments worsen the heart’s ability to pump as well as it should. Examples include the drugs trastuzumab and doxorubicin. In this study, researchers want to assess the drug vericiguat for heart problems caused by breast cancer treatment. Vericiguat boosts the activity of an enzyme that you need for normal heart function. It may help improve the way your lungs, heart, blood vessels, and muscles work.

If you join this study, you will be randomly assigned to get one of these treatments:

  • The usual treatment for breast cancer treatment-related heart problems
  • Vericiguat plus the usual treatment for breast cancer treatment-related heart problems

Vericiguat is already used to treat heart failure. It is taken orally (by mouth).

Who Can Join

To join this study, there are a few conditions. You must:

  • Have had a lowering of your heart function that is due to breast cancer treatment. Your left ventricular ejection fraction (LVEF, a measure of your heart’s pumping ability) must drop by 10% or more and be less than 53%.
  • Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Anthony Yu’s office at 212-639-7932.

Protocol

23-050

Phase

Phase II (phase 2)

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT05806138