A Phase 2 interventional study of Empagliflozin in Breast Cancer and Supportive Care in Cancer, sponsored by Virginia Commonwealth University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Virginia Commonwealth University · Phase 2, Interventional, and Supportive care
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.
This is a prospective, single-arm pilot study designed to evaluate the feasibility of treating breast cancer patients receiving potentially cardiotoxic chemotherapy with empagliflozin 10 mg daily to prevent heart failure progression. Participants will undergo study assessments at baseline and again approximately 3 months later. The study will collect clinical, imaging, functional, and biomarker data to inform the design of future, larger clinical trials
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's planned enrollment of 10 is below the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Virginia Commonwealth University is the lead sponsor of 648 studies on the registry; 82 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 64 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Empagliflozin 10 mg oral tablet
Drug: Empagliflozin
Empagliflozin 10 milligrams (mg) taken by mouth once daily.
Evaluate the feasibility of investigating 10 mg/day empagliflozin in breast cancer patients receiving anthracycline-based chemotherapy, including participant recruitment
The number of participants enrolled
Time frame: Day 1 (Estimated enrollment period of 6 months)
Evaluate the acceptability of a clinical trial protocol investigating 10 mg/day empagliflozin in breast cancer patients receiving anthracycline-based chemotherapy, including medication adherence
The number of participants that complete the protocol defined intervention and follow-up
Time frame: 45 Days (+/- a week)
Evaluate the acceptability of a clinical trial protocol investigating 10 mg/day empagliflozin in breast cancer patients receiving anthracycline-based chemotherapy including medication adherence
The number of participants that adhere to the medication intervention
Time frame: 45 Days (+/- a week)
Evaluate the safety of 10 mg/day empagliflozin by evaluating medication tolerance
The number of adverse events related to empagliflozin
Time frame: Baseline, through 3-month follow-up (45 days following treatment initiation (+/-) one week)
Evaluate the safety of 10 mg/day empagliflozin by evaluating medication safety and tolerance
Safety and tolerance will also be assessed by the number of participants requiring discontinuation of empagliflozin due to adverse events
Time frame: Baseline, through 3-month follow-up (45 days following treatment initiation (+/-) one week)
Collect measures of cardiac function, and to assess the variability of these measures to inform sample size calculations and power analyses for future studies.
Collect preliminary measures of cardiac function, including left ventricular ejection fraction (LVEF). LVEF is the percentage of blood pumped out of the left ventricle with each heartbeat. 55-69%: Normal, 45-54%: Mildly reduced, 30-44%: Moderately reduced, \<30%: Severely reduced
Time frame: Baseline, and 3-month follow-up (45 days following treatment initiation (+/-) one week)
Collect measures of cardiac function and to assess the variability of these measures to inform sample size calculations and power analyses for future studies.
Collect preliminary measures of cardiac function, including cardiac output (CO). CO is the total volume of blood pumped by the heart per minute, measured by cardiovascular magnetic resonance imaging (CMR).
Time frame: Baseline, and 3-month follow-up (45 days following treatment initiation (+/-) one week)
Collect measures of cardiac function, and to assess the variability of these measures to inform sample size calculations and power analyses for future studies.
Collect preliminary measures of cardiac function, including 6 minute walk distance. The six-minute walk test (6MWT) is a validated, submaximal exercise test that measures the distance a patient can walk on a flat, hard surface in six minutes. The 6MWT evaluates how well the cardiopulmonary, musculoskeletal, and metabolic systems work together during physical activity
Time frame: Baseline, and 3-month follow-up (45 days following treatment initiation (+/-) one week)
Collect measures inflammatory biomarkers, and circulating ceramides, and to assess the variability of these measures to inform sample size calculations and power analyses for future studies.
Collect preliminary measures of cardiac function, including collecting blood samples for inflammatory biomarker analyses.
Time frame: Baseline, and 3-month follow-up (45 days following treatment initiation (+/-) one week)
Plan to share: No — Any datasets shared with other researchers would contain only de-identified data.
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Sep 2027, 9 months later.
Of 983 non-industry phase 2 interventional studies under Breast Neoplasms, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 85. This study's planned 9 months is below that.
Counting every sponsor, half of 1,201 studies reached it within 49 months; a quarter within 31 and three quarters within 80.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Empagliflozin
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