RightFit
Not yet recruitingPhase 2

EMBRACE (EMPA in BReast Cancer for Activity and Cardiac ProtEction)

Cardioprotective Effects of Empagliflozin in Breast Cancer Patients Receiving Chemotherapy: A Pilot Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 85 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This small study tests whether a trial of empagliflozin, taken at 10 mg each day, is practical to run and acceptable to patients. It is for adults with breast cancer who are receiving a type of chemotherapy called anthracyclines.

The primary objective of this pilot study is to evaluate the feasibility and acceptability of a clinical trial protocol investigating 10 mg/day empagliflozin in breast cancer patients receiving anthracycline-based chemotherapy.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 to 85.
  • Have stage I–III breast cancer being treated with the goal of a cure. It may be inflammatory, newly diagnosed, or back in the same area, but must not have spread to distant parts of the body.
  • Plan to receive anthracycline chemotherapy, with or without hormone-blocking drugs called aromatase inhibitors.
  • Have an ECOG activity score of 0–2: able to care for yourself and be up and about at least half of your waking hours.
  • Can walk at least 2 blocks without chest pain, trouble breathing, or fainting.
  • Can speak, read, and understand enough English to agree to join and complete study tasks.
  • You may also be taking part in another clinical trial.

Who can't join

  • Blood pressure with a top number above 190 or a bottom number above 100.
  • Recent alcohol or drug abuse.
  • Type 1 diabetes; an illness causing inflammation, such as lupus or inflammatory bowel disease; or another condition that could make the study unsafe or hard to finish.
  • Cannot safely have an MRI scan, such as because of certain metal implants or a clip on a brain blood vessel; or have a fear of enclosed spaces.
  • Already taking empagliflozin when checked for or enrolled in the study.
  • More than 20 extra heartbeats from the lower heart chambers per minute; atrial fibrillation, an irregular heartbeat, with a heart rate above 130; or a heart attack within the past 28 days.
  • Pregnant or planning to move within 6 months of joining.
  • Cannot give informed consent, meaning you understand and agree to join, or cannot use English well enough to give consent and complete study tasks.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Stage I-III breast cancer (including inflammatory and newly diagnosed, or locally recurrent but not metastatic breast cancer being treated with curative intent) * 18-85 years old * Scheduled to receive anthracycline based chemotherapy with or without estrogen antagonist aromatase inhibitors (anastrozole \[Arimidex\], letrozole \[Femara\], exemestane \[Aromasin\]). * Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2 * Able to walk at least 2 blocks without chest pain, dyspnea or fainting * Participants in other ongoing clinical trials are eligible for this study * Participants must be able to speak, read, and understand English sufficiently to provide informed consent and complete all study-related procedures and assessments. Exclusion Criteria: * Uncontrolled hypertension (systolic blood pressure \>190 mm Hg or diastolic blood pressure \>100 mm Hg) * A recent history of alcohol or drug abuse * Inflammatory conditions such as lupus or inflammatory bowel disease, or another medical condition that might compromise safety or successful completion * Type I diabetes * Contraindications to Magnetic resonance imaging (MRI) (example: iron-based metal implants, cerebral aneurysm clip) * Current treatment with empagliflozin at the time of screening or enrollment * Significant ventricular arrhythmias (PVC) (\>20 PVCs/min due to gating difficulty) * Atrial fibrillation with uncontrolled ventricular response (\>130 bpm) * Acute myocardial infarction within 28 days * Claustrophobia * Pregnancy * Those unable to provide informed consent * Moving within 6 mos. of enrollment * Individuals who are unable to speak, read, or understand English sufficiently to provide informed consent and complete study procedures will be excluded.

Study sites (1)

VA