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

NCT06304857 | Recruiting Phase 3 DMC

• 2 other identifiers: 2022/ABM/01/000392023-506631-15-00
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Breast Cancer; Heart Failure

Keywords

breast cancer; heart failure; ejection fraction; anthracyclines

Outcome Measures

Primary Outcomes (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.

  12 months

Secondary Outcomes (17)

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

  6 months

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

  6 and 12 months

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

  6 and 12 months

• Change in Troponin I after 6 and 12 months.

  6 and 12 months

• Change in NTproBNP levels at 6 and 12 months.

  6 and 12 months

Study Arms (2)

Dapagliflozin

EXPERIMENTAL

Dapagliflozin 10 mg tablet orally once daily for 12 months

Drug: Dapagliflozin

Placebo

PLACEBO COMPARATOR

Placebo tablet matching dapagliflozin orally once daily for 12 months

Drug: Placebo

Interventions

Dapagliflozin DRUG

10 mg tablet q.d

Also known as: Farxiga, Forxiga

Dapagliflozin

Placebo DRUG

tablet matching dapagliflozin 10 mg q.d

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• 4th Military Clinical Hospital with Polyclinic, Poland: lead

Study Sites (3)

4th Military Clinical Hospital with Polyclinic

Wroclaw, Lower Silesian Voivodeship, 50-981, Poland

RECRUITING

Lower Silesian Centre for Oncology, Lung Diseases and Hematology

Wroclaw, Lower Silesian Voivodeship, 53-413, Poland

RECRUITING

Military Medical Institute

Warsaw, Masovian Voivodeship, 04-141, Poland

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Heart Failure

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Waldemar Banasiak, PhD, MD

  4th Military Clinical Hospital with Polyclinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bartosz Krakowiak, PhD, MD

CONTACT

+48 261 660 234; bkrakowiak@4wsk.pl

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: March 12, 2024
• Study Start: April 15, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (3)