Breast CancerPhase 2EMBRACENCT07883512
EMBRACE (EMPA in BReast Cancer for Activity and Cardiac ProtEction)
A Phase 2 study testing Empagliflozin in people with Breast Cancer and Supportive Care in Cancer, run by Virginia Commonwealth University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Breast Cancer, Supportive Care in Cancer
- What is being tested?
- Empagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 30 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
Pamela Grizzard, 804-628-6234, pamela.grizzard@vcuhealth.org
Elisa Palladino, Ph.D
About this study
Official title: Cardioprotective Effects of Empagliflozin in Breast Cancer Patients Receiving Chemotherapy: A Pilot Study
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.
Read the detailed description
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
- Conditions
- Breast Cancer, Supportive Care in Cancer
- Being tested
- Empagliflozin
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmpagliflozinDrug
Empagliflozin 10 milligrams (mg) taken by mouth once daily.
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin | Experimental | Empagliflozin 10 mg oral tablet Receives: Drug: Empagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 45 Days (+/- a week)
Evaluate the safety of 10 mg/day empagliflozin by evaluating medication tolerance
The number of adverse events related to empagliflozin
Measured: 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
Measured: Baseline, through 3-month follow-up (45 days following treatment initiation (+/-) one week)
Secondary outcomes (4)
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
Measured: 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).
Measured: 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
Measured: 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.
Measured: Baseline, and 3-month follow-up (45 days following treatment initiation (+/-) one week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot Study
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisa Palladino, Ph.D, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07883512
- Sponsor's protocol ID
- SOM-300001431
- Other IDs
- MCC-26-23388, HM300001431
- Acronym
- EMBRACE
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Any datasets shared with other researchers would contain only de-identified data.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardioprotective Effects of Empagliflozin in Breast Cancer Patients Receiving Chemotherapy: A Pilot Study
- ClinicalTrials.gov ID
- NCT07883512
- Acronym / sponsor ID
- EMBRACE / SOM-300001431
- Conditions
- Breast Cancer, Supportive Care in Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 20 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot Study
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin | Experimental | Drug: EmpagliflozinEmpagliflozin 10 mg oral tablet |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EmpagliflozinEmpagliflozin 10 milligrams (mg) taken by mouth once daily. | Drug | Empagliflozin |
Primary outcome
Evaluate the feasibility of investigating 10 mg/day empagliflozin in breast cancer patients receiving anthracycline-based chemotherapy, including participant recruitment
Time frame: Day 1 (Estimated enrollment period of 6 months)
The number of participants enrolled
Evaluate the acceptability of a clinical trial protocol investigating 10 mg/day empagliflozin in breast cancer patients receiving anthracycline-based chemotherapy, including medication adherence
Time frame: 45 Days (+/- a week)
The number of participants that complete the protocol defined intervention and follow-up
Evaluate the acceptability of a clinical trial protocol investigating 10 mg/day empagliflozin in breast cancer patients receiving anthracycline-based chemotherapy including medication adherence
Time frame: 45 Days (+/- a week)
The number of participants that adhere to the medication intervention
Evaluate the safety of 10 mg/day empagliflozin by evaluating medication tolerance
Time frame: Baseline, through 3-month follow-up (45 days following treatment initiation (+/-) one week)
The number of adverse events related to empagliflozin
Evaluate the safety of 10 mg/day empagliflozin by evaluating medication safety and tolerance
Time frame: Baseline, through 3-month follow-up (45 days following treatment initiation (+/-) one week)
Safety and tolerance will also be assessed by the number of participants requiring discontinuation of empagliflozin due to adverse events
4 secondary outcomes
Collect measures of cardiac function, and to assess the variability of these measures to inform sample size calculations and power analyses for future studies.
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.
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.
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.
Time frame: Baseline, and 3-month follow-up (45 days following treatment initiation (+/-) one week)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No. Any datasets shared with other researchers would contain only de-identified data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elisa Palladino, Ph.D principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Empagliflozin in people with Breast Cancer and Supportive Care in Cancer, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pamela Grizzard (804-628-6234, pamela.grizzard@vcuhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the feasibility of investigating 10 mg/day empagliflozin in breast cancer patients receiving anthracycline-based chemotherapy, including participant recruitment (time frame: Day 1 (Estimated enrollment period of 6 months)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.