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Not Yet Recruiting
NCT07883512
EMBRACE (EMPA in BReast Cancer for Activity and Cardiac ProtEction)
Conditions: Breast Cancer, Supportive Care in Cancer
Sex: All
Ages: 18 Years – 85 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 10
Sponsor: Virginia Commonwealth University
Location: Virginia Commonwealth University Richmond Virginia
Summary
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.
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.
Source: ClinicalTrials.gov (NCT07883512). StuddyBuddy aggregates publicly available trial information.