AzTrials
AzTrials

Breast CancerPhase 3PROTECTAANCT06304857

CardioPROTECTion with Dapagliflozin in Breast Cancer Patients Treated with AnthrAcycline - PROTECTAA TRIAL

A Phase 3 study testing Dapagliflozin in people with Breast Cancer and Heart Failure, run by 4th Military Clinical Hospital with Polyclinic, Poland at 3 sites in Poland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the effect of dapagliflozin on the incidence of cancer therapeutics-related cardiac dysfunction in patients with breast cancer receiving anthracycline treatment. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Breast Cancer, Heart Failure
What is being tested?
Dapagliflozin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
188 participants
Where
3 sitesPoland
Study dates
15 Apr 2024to 31 Dec 2027
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age > 18 years and < 80 years.
  • Diagnosis of invasive breast cancer [stage I-III] and planned anthracycline treatment within 60 days.
  • Signed Informed Consent to participate in the study.

Who cannot join

  • Urinary tract infection with the need for treatment with an antibiotic 48 hours before the scheduled start of anthracycline treatment.
  • Recognised heart failure or symptoms which, in the opinion of the investigator may be a symptom of undiagnosed heart failure.
  • Left ventricular ejection fraction < 50% at the time of the screening.
  • Severe valvular heart disease.
  • A history of clinically significant arrhythmia, including atrial fibrillation regardless of type (at discretion of the investigator).
  • A history of stroke.
Show all 24Show fewer
  • Cardiomyopathy: congenital, post-inflammatory, toxic, infiltrative (e.g. amyloidosis, sarcoidosis, haemochromatosis), postnatal or hypertrophic.
  • Pulmonary hypertension.
  • Uncontrolled arterial pressure or systolic pressure < 80 mmHg at screening (at the discretion of the investigator).
  • BMI > 40 kg/m2.
  • Diagnosed type 1 or type 2 diabetes or fasting glucose ≥ 126 mg/dl or HbA1C ≥ 6,5% (48 mmol/mol).
  • Pregnancy or breastfeeding.
  • Lack of compliance to use highly effective method of birth control.
  • Expected or possible treatment with epirubicin or liposomal doxorubicin within 12 months.
  • Taking another study drug or drugs from the group of SGLT2 inhibitors up to 6 months before the screening visit.
  • Taking semaglutide, liraglutide and metformin during the 30 days preceding the screening visit.
  • eGFR < 25 ml/min/1.73m2 according to CKD EPI.
  • Life expectancy < 12 months or cancer disease stage IV according to the TNM classification.
  • Alanine transaminase or aspartate transaminase levels above 2.5 times the local norm.
  • Anemia with Hemoglobin < 9 g/dl.
  • Kidney failure > G2 (according to KDIGO classification).
  • Liver disorders, Child-Pugh score > 4.
  • Known, active infections with HIV, HBV, HCV, tuberculosis.
  • Any other condition which, in the opinion of the investigator, makes it impossible to fulfill the requirements for participation in this study.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Bartosz Krakowiak, PhD, MD contact

+48 261 660 234

bkrakowiak@4wsk.pl

Poland3 sites, 3 recruiting

  • Military Medical Institute

    Warsaw, Masovian Voivodeship, 04-141

    Paweł Krzesiński, PhD, MD

    Recruiting

  • 4th Military Clinical Hospital with Polyclinic

    Wroclaw, Lower Silesian Voivodeship, 50-981

    Bartosz Krakowiak, PhD, MD, +48 261 660 234, bkrakowiak@4wsk.pl

    Recruiting

  • Lower Silesian Centre for Oncology, Lung Diseases and Hematology

    Wroclaw, Lower Silesian Voivodeship, 53-413

    Rafał Matkowski, PhD, MD

    Recruiting

Other trials in Poland

About this study

Official title: A Multicentre, Randomised, Double-blind, Placebo-controlled Phase III Study, Evaluating the Effect of Dapagliflozin on Prevention of Cardiotoxicity in Breast Cancer Patients Undergoing Anthracycline-based Chemotherapy

The purpose of this study is to evaluate the effect of dapagliflozin on the incidence of cancer therapeutics-related cardiac dysfunction in patients with breast cancer receiving anthracycline treatment.

Read the detailed description

This is a multicentre, randomised, double-blind, placebo-controlled phase III study, evaluating the effect of dapagliflozin versus placebo on prevention of cardiotoxicity in breast cancer patients undergoing anthracycline-based chemotherapy.

Being tested
Dapagliflozin, Placebo
Keywords
breast cancer, heart failure, ejection fraction, anthracyclines
Medical subject headings
Breast Neoplasms, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DapagliflozinDrug

    Also called Farxiga, Forxiga

    10 mg tablet q.d

  • PlaceboDrug

    tablet matching dapagliflozin 10 mg q.d

Study groups in NCT06304857
Study groupRoleWhat they receive
DapagliflozinExperimentalDapagliflozin 10 mg tablet orally once daily for 12 months
Receives: Drug: Dapagliflozin
PlaceboPlacebo comparatorPlacebo tablet matching dapagliflozin orally once daily for 12 months
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary efficacy composite endpoint (cancer therapeutics related cardiac dysfunction) at 12 months.

    Incidence of cancer therapeutics related cardiac dysfunction defined as:

    1. the appearance of heart failure symptoms (NYHA class I-IV) due to an impairment of heart function or structure within 12 months; or
    2. asymptomatic decrease in left ventricular ejection fraction > 10% after 12 months; or
    3. asymptomatic decrease in left ventricular ejection fraction < 10% but up to 40-49% after 12 months; or
    4. asymptomatic decrease in global left ventricular longitudinal strain >15% after 12 months; or
    5. asymptomatic increase in biomarkers (troponin I > upper reference limit (99th centile) and increase of at least 30% from pre-treatment concentration or NTproBNP > 125 pg/ml and increase of at least 30% from baseline) after 12 months.

    Measured: 12 months

Secondary outcomes (17)

  1. Secondary efficacy composite endpoint (cancer therapeutics related cardiac dysfunction) at 6 months.

    Incidence of cancer therapeutics related cardiac dysfunction defined as:

    1. emergence of heart failure symptoms (NYHA class I-IV) due to impaired cardiac function or structure at 6 months; or
    2. decrease LVEF > 10% after 6 months; or
    3. decrease LVEF < 10% but to a value of 40-49% after 6 months; or
    4. a decrease in global longitudinal strain of > 15% after 6 months; or
    5. asymptomatic increase in biomarkers (troponin I > upper reference limit (99th centile) and an increase of at least 30% from pre-treatment concentration or NTproBNP >125pg/ml and an increase of at least 30% from baseline) after 6 months.

    Measured: 6 months

  2. Change in left ventricular ejection fraction at 6 and 12 months.

    Assessed by transthoracic echocardiography.

    Measured: 6 and 12 months

  3. Change in left ventricular diastolic function at 6 and 12 months.

    Assessed as the ratio of E/E', i.e. maximum mitral annular inflow velocity during the rapid ventricular filling phase, to maximum mitral annular motion velocity by tissue Doppler during the rapid ventricular filling phase.

    Measured: 6 and 12 months

  4. Change in Troponin I after 6 and 12 months.

    Secondary.

    Measured: 6 and 12 months

  5. Change in NTproBNP levels at 6 and 12 months.

    Secondary.

    Measured: 6 and 12 months

  6. Quality of life at 6 and 12 months assessed using the five-dimensional EQ-5D questionnaire.

    The EQ-5D questionnaire consists of two parts: descriptive one, which measures five dimensions of health (mobility, self care, usual activities, pain \& discomfort, anxiety \& depression) and EQ Visual Analogue Scale numbered from 0 to 100, where higher value indicate better self-reported health.

    Measured: 6 and 12 months

  7. Occurrence of death from any cause.

    Secondary safety endpoint.

    Measured: 13 months (additional 1 month of safety follow-up after end of treatment).

  8. Composite endpoint of cardiovascular events.

    Secondary safety endpoint. Occurrence of death from cardiovascular causes, nonfatal myocardial infarction, non-fatal stroke.

    Measured: 13 months (additional 1 month of safety follow-up after end of treatment).

  9. Occurrence of death from any cardiovascular reasons.

    Secondary safety endpoint.

    Measured: 13 months (additional 1 month of safety follow-up after end of treatment).

  10. Occurrence of non-fatal myocardial infarction.

    Secondary safety endpoint.

    Measured: 13 months (additional 1 month of safety follow-up after end of treatment).

  11. Occurrence of non-fatal stroke.

    Secondary safety endpoint.

    Measured: 13 months (additional 1 month of safety follow-up after end of treatment).

  12. Occurrence of hypoglycaemia.

    Secondary safety endpoint. Hypoglycaemia is defined as serum glucose level 3 mmol/l (<54 mg/dl) with coexisting related clinical symptoms.

    Measured: 13 months (additional 1 month of safety follow-up after end of treatment).

  13. Occurrence of ionic disorders.

    Secondary safety endpoint, defined as occurrence of:

    • Sodium plasma level of >150 mmol/L
    • Potassium plasma level of >6.0 mmol/L

    Measured: 13 months (additional 1 month of safety follow-up after end of treatment).

  14. Occurrence of renal failure.

    Secondary safety endpoint. Defined as:

    • sustained (i.e. >28 days) decline in eGFR ≥50% AND/OR
    • reaching end stage renal disease defined as:
    • sustained (i.e. >28 days) eGFR <15 mL/min/1.73 m2
    • chronic dialysis treatment
    • receiving a renal transplant AND/OR
    • renal death

    Measured: 13 months (additional 1 month of safety follow-up after end of treatment).

  15. Occurrence of hypersensitivity to investigated drug.

    Secondary safety endpoint. Any unexpected adverse drug reaction (UADR).

    Measured: 13 months (additional 1 month of safety follow-up after end of treatment).

  16. Occurrence of allergic reactions.

    Secondary safety endpoint. Any hypersensitivity reaction with proven immunological pathomechanism (types I-IV according to Coombs and Gell).

    Measured: 13 months (additional 1 month of safety follow-up after end of treatment).

  17. Occurrence of infection.

    Secondary safety endpoint. Any symptomatic infection (viral, bacterial or fungal).

    Measured: 13 months (additional 1 month of safety follow-up after end of treatment).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2024
  2. Study start15 Apr 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
188 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06304857
Sponsor's protocol ID
2022/ABM/01/00039
Other IDs
2023-506631-15-00, 2023
Acronym
PROTECTAA
Status last verified
Dec 2024
First submitted
9 Oct 2023
Last updated
4 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dapagliflozin in people with Breast Cancer and Heart Failure, run by 4th Military Clinical Hospital with Polyclinic, Poland at 3 sites in Poland.

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 3 inclusion and 24 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 4 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 3 sites in Poland. 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 Bartosz Krakowiak, PhD, MD (+48 261 660 234, bkrakowiak@4wsk.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary efficacy composite endpoint (cancer therapeutics related cardiac dysfunction) at 12 months. (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06304857.

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 4 Dec 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in