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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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07883512). StuddyBuddy aggregates publicly available trial information.