Breast CancerPhase 3DAPA-MYOCANCERNCT06711185
Effect of DAPAglifozin on MYOcardial Remodeling of Breast CANCER Patients Treated with Anthracycline Based Chemotherapy
A Phase 3 study testing Dapagliflozin 10 mg in people with Breast Cancer, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
Prospective, randomized, double-blind, controlled clinical trial to compare the effect of 9 months of treatment with dapagliflozin vs. placebo on anthracycline-induced cardiotoxicity in patients with breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Dapagliflozin 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Jan 2024to 30 Aug 2026
- Phase
- Phase 3
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Over 18 years old
- Breast cancer
- Chemotherapy as treatment planning and programmed cumulative dose equivalent to 240 mg/m2 of doxorubicin.
Who cannot join
- Contraindications for performing CMR exams, such as patients with pacemakers or cardiac defibrillators of any type, metal clips for cerebral aneurysms, cochlear implants, and ventriculoperitoneal bypass valves.
- Inability to perform CMR due to claustrophobia.
- Renal failure with a glomerular filtration rate < 30 ml/min/1.73 m2.
- Previous history of myocardial infarction, congestive heart failure, or myocardial revascularization, whether percutaneous or surgical.
- Previous history of significant valvular heart disease.
- Previous history of cardiomyopathies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clinicas da Unicamp
Campinas, São Paulo, 13083-888
Joaquim B Oliveira, MD, +55 19 3521 7959, jba.clinicamedica@gmail.com
Joaquim Barreto Oliveira, MD
About this study
Prospective, randomized, double-blind, controlled clinical trial to compare the effect of 9 months of treatment with dapagliflozin vs. placebo on anthracycline-induced cardiotoxicity in patients with breast cancer.
Read the detailed description
Anthracycline-based chemotherapy is the standard treatment for several common cancer types, including breast cancer, lymphoma and sarcoma. However, within 12 months, up to 20% of the 1,000,000 patients worldwide treated with anthracyclines each year have a significant reduction in left ventricular ejection fraction (LVEF), leading to a three to six-fold higher rates of incident heart failure. Once established, anthracycline-induced heart failure carries a poor prognosis with a 2-year survival of only 40%.
Consistent data have established that sodium-glucose transport protein 2 (SGLT2) inhibitors reduce incident heart failure in patients without cancer. There is biological plausibility and animal data to support the hypothesis central to this proposal that SGLT2 will reduce anthracycline-induced cardiotoxicity (AIC). Anthracyclines increase inflammatory cytokines, increase cell death, increase myocardial fibrosis leading to a decrease in the LVEF. In animal and cellular models, SGLT2 inhibitors reduce inflammatory cytokines, increase cell viability, reduce myocardial fibrosis and prevent the decline in LVEF with anthracyclines. There are no preliminary clinical data testing whether SGLT2 inhibitors are cardioprotective during treatment with anthracyclines among patients with breast cancer.
We propose a single-center randomized double-blind placebo-controlled trial, in 80 patients, who will be randomized 1:1 to dapagliflozin 10mg/daily or placebo to determine whether dapagliflozin started prior to anthracyclines reduces AIC in patients breast cancer. The endpoint AIC will be defined as a 6% difference in the change in LVEF between groups within the first 9 months after the start of therapy. LVEF will be measured using the gold-standard, cardiac magnetic resonance (CMR), performed in an established core clinical trials laboratory by expert researchers.
Participants will be recruited over 2 years from a large volume academic oncology network. Myocardial fibrosis is a key intermediary that occurs prior to the development of LV dysfunction. CMR is the gold-standard imaging technique for fibrosis; therefore, to test whether the sub-acute development of myocardial fibrosis can predict the late occurrence of AIC and whether dapagliflozin reduces myocardial fibrosis, we also propose measuring the extent of fibrosis at baseline and 9 months.
We hypothesize that dapagliflozin will attenuate the anthracycline-induced increase in myocardial fibrosis. Secondary and exploratory outcomes will include significant changes in myocardial perfusion assessed by stress CMR, flow-mediated vasodilatation assessed by ultrasound, exercise capacity assessed by cardiopulmonary exercise test, and biomarkers.
If successful, this study will show that dapagliflozin started prior to anthracyclines will preserve the LVEF and will attenuate the anthracycline-induced cardiovascular toxicity.
- Conditions
- Breast Cancer
- Being tested
- Dapagliflozin 10 mg, Placebo
- Keywords
- Dapagliflozin, Anthracyclines, chemotherapy induced cardiomyopathy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10 mgDrug
Patients in this group will receive 1 tablet of 10mg dapagliflozin daily for 9 months, starting 7-10 days before chemotherapy treatment.
PlaceboOther
Patients in this group will receive 1 placebo tablet per day, with identical characteristics to the group receiving dapagliflozin, for 9 months, starting 7-10 days before the start of chemotherapy treatment
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin | Experimental | Standard chemotherapy treatment + Dapagliflozin 10mg/day. Receives: Drug: Dapagliflozin 10 mg |
| Placebo Group | Placebo comparator | Standard chemotherapy treatment + Placebo. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in left ventricle ejection fraction
The primary outcome will be the 6% difference in the mean of left ventricle ejection fraction change, as assessed by CMR, between the placebo group and the dapagliflozin group
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start30 Jan 2024
- Primary completion30 Jan 2026 (estimated)
- Study completion30 Aug 2026 (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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Otavio Rizzi Coelho Filho, University of Campinas, Brazil
- Investigators
- Otavio Rizzi Coelho-Filho, MD, MPH, PhD, Principal investigator, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06711185
- Sponsor's protocol ID
- 57488122.1.0000.5404
- Acronym
- DAPA-MYOCANCER
- Status last verified
- Nov 2024
- First submitted
- 26 Nov 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of DAPAglifozin on MYOcardial Remodeling of Breast CANCER Patients Treated with Anthracycline Based Chemotherapy
- ClinicalTrials.gov ID
- NCT06711185
- Acronym / sponsor ID
- DAPA-MYOCANCER / 57488122.1.0000.5404
- Conditions
- Breast Cancer
- Keywords
- Dapagliflozin, Anthracyclines, chemotherapy induced cardiomyopathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- 30 Jan 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 2 Dec 2024 (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.
Prospective, randomized, double-blind, controlled clinical trial to compare the effect of 9 months of treatment with dapagliflozin vs. placebo on anthracycline-induced cardiotoxicity in patients with breast cancer.
Detailed description
Anthracycline-based chemotherapy is the standard treatment for several common cancer types, including breast cancer, lymphoma and sarcoma. However, within 12 months, up to 20% of the 1,000,000 patients worldwide treated with anthracyclines each year have a significant reduction in left ventricular ejection fraction (LVEF), leading to a three to six-fold higher rates of incident heart failure. Once established, anthracycline-induced heart failure carries a poor prognosis with a 2-year survival of only 40%.
Consistent data have established that sodium-glucose transport protein 2 (SGLT2) inhibitors reduce incident heart failure in patients without cancer. There is biological plausibility and animal data to support the hypothesis central to this proposal that SGLT2 will reduce anthracycline-induced cardiotoxicity (AIC). Anthracyclines increase inflammatory cytokines, increase cell death, increase myocardial fibrosis leading to a decrease in the LVEF. In animal and cellular models, SGLT2 inhibitors reduce inflammatory cytokines, increase cell viability, reduce myocardial fibrosis and prevent the decline in LVEF with anthracyclines. There are no preliminary clinical data testing whether SGLT2 inhibitors are cardioprotective during treatment with anthracyclines among patients with breast cancer.
We propose a single-center randomized double-blind placebo-controlled trial, in 80 patients, who will be randomized 1:1 to dapagliflozin 10mg/daily or placebo to determine whether dapagliflozin started prior to anthracyclines reduces AIC in patients breast cancer. The endpoint AIC will be defined as a 6% difference in the change in LVEF between groups within the first 9 months after the start of therapy. LVEF will be measured using the gold-standard, cardiac magnetic resonance (CMR), performed in an established core clinical trials laboratory by expert researchers.
Participants will be recruited over 2 years from a large volume academic oncology network. Myocardial fibrosis is a key intermediary that occurs prior to the development of LV dysfunction. CMR is the gold-standard imaging technique for fibrosis; therefore, to test whether the sub-acute development of myocardial fibrosis can predict the late occurrence of AIC and whether dapagliflozin reduces myocardial fibrosis, we also propose measuring the extent of fibrosis at baseline and 9 months.
We hypothesize that dapagliflozin will attenuate the anthracycline-induced increase in myocardial fibrosis. Secondary and exploratory outcomes will include significant changes in myocardial perfusion assessed by stress CMR, flow-mediated vasodilatation assessed by ultrasound, exercise capacity assessed by cardiopulmonary exercise test, and biomarkers.
If successful, this study will show that dapagliflozin started prior to anthracyclines will preserve the LVEF and will attenuate the anthracycline-induced cardiovascular toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin | Experimental | Drug: Dapagliflozin 10 mgStandard chemotherapy treatment + Dapagliflozin 10mg/day. |
| Placebo Group | Placebo comparator | Other: PlaceboStandard chemotherapy treatment + Placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female
- Over 18 years old
- Breast cancer
- Chemotherapy as treatment planning and programmed cumulative dose equivalent to 240 mg/m2 of doxorubicin.
Key exclusion criteria (6 listed)
- Contraindications for performing CMR exams, such as patients with pacemakers or cardiac defibrillators of any type, metal clips for cerebral aneurysms, cochlear implants, and ventriculoperitoneal bypass valves.
- Inability to perform CMR due to claustrophobia.
- Renal failure with a glomerular filtration rate < 30 ml/min/1.73 m2.
- Previous history of myocardial infarction, congestive heart failure, or myocardial revascularization, whether percutaneous or surgical.
- Previous history of significant valvular heart disease.
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 |
|---|---|---|
| Dapagliflozin 10 mgPatients in this group will receive 1 tablet of 10mg dapagliflozin daily for 9 months, starting 7-10 days before chemotherapy treatment. | Drug | Dapagliflozin |
| PlaceboPatients in this group will receive 1 placebo tablet per day, with identical characteristics to the group receiving dapagliflozin, for 9 months, starting 7-10 days before the start of chemotherapy treatment | Other | Placebo Group |
Primary outcome
Change in left ventricle ejection fraction
Time frame: 36 weeks
The primary outcome will be the 6% difference in the mean of left ventricle ejection fraction change, as assessed by CMR, between the placebo group and the dapagliflozin group
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 2 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
Otavio Rizzi Coelho-Filho, MD, MPH, PhD principal investigator
University of Campinas, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dapagliflozin 10 mg in people with Breast Cancer, run by University of Campinas, Brazil at 1 site in Brazil.
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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 2 Dec 2024. 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 Brazil. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Otavio Rizzi Coelho-Filho, MD, MPH, PhD (+55 19 3521-7755, tavicocoelho@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in left ventricle ejection fraction (time frame: 36 weeks). 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 2 Dec 2024.