Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2026-01-02 @ 1:35 PM
Study NCT ID:
NCT06304857
Status:
RECRUITING
Last Update Posted:
2024-12-04
First Post:
2023-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CardioPROTECTion with Dapagliflozin in Breast Cancer Patients Treated with AnthrAcycline - PROTECTAA TRIAL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C529054', 'term': 'dapagliflozin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 188}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-02', 'studyFirstSubmitDate': '2023-10-09', 'studyFirstSubmitQcDate': '2024-03-08', 'lastUpdatePostDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary efficacy composite endpoint (cancer therapeutics related cardiac dysfunction) at 12 months.', 'timeFrame': '12 months', 'description': 'Incidence of cancer therapeutics related cardiac dysfunction defined as:\n\n1. the appearance of heart failure symptoms (NYHA class I-IV) due to an impairment of heart function or structure within 12 months; or\n2. asymptomatic decrease in left ventricular ejection fraction \\> 10% after 12 months; or\n3. asymptomatic decrease in left ventricular ejection fraction \\< 10% but up to 40-49% after 12 months; or\n4. asymptomatic decrease in global left ventricular longitudinal strain \\>15% after 12 months; or\n5. 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.'}], 'secondaryOutcomes': [{'measure': 'Secondary efficacy composite endpoint (cancer therapeutics related cardiac dysfunction) at 6 months.', 'timeFrame': '6 months', 'description': 'Incidence of cancer therapeutics related cardiac dysfunction defined as:\n\n1. emergence of heart failure symptoms (NYHA class I-IV) due to impaired cardiac function or structure at 6 months; or\n2. decrease LVEF \\> 10% after 6 months; or\n3. decrease LVEF \\< 10% but to a value of 40-49% after 6 months; or\n4. a decrease in global longitudinal strain of \\> 15% after 6 months; or\n5. 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.'}, {'measure': 'Change in left ventricular ejection fraction at 6 and 12 months.', 'timeFrame': '6 and 12 months', 'description': 'Assessed by transthoracic echocardiography.'}, {'measure': 'Change in left ventricular diastolic function at 6 and 12 months.', 'timeFrame': '6 and 12 months', 'description': "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."}, {'measure': 'Change in Troponin I after 6 and 12 months.', 'timeFrame': '6 and 12 months', 'description': 'Secondary.'}, {'measure': 'Change in NTproBNP levels at 6 and 12 months.', 'timeFrame': '6 and 12 months', 'description': 'Secondary.'}, {'measure': 'Quality of life at 6 and 12 months assessed using the five-dimensional EQ-5D questionnaire.', 'timeFrame': '6 and 12 months', 'description': '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.'}, {'measure': 'Occurrence of death from any cause.', 'timeFrame': '13 months (additional 1 month of safety follow-up after end of treatment).', 'description': 'Secondary safety endpoint.'}, {'measure': 'Composite endpoint of cardiovascular events.', 'timeFrame': '13 months (additional 1 month of safety follow-up after end of treatment).', 'description': 'Secondary safety endpoint. Occurrence of death from cardiovascular causes, nonfatal myocardial infarction, non-fatal stroke.'}, {'measure': 'Occurrence of death from any cardiovascular reasons.', 'timeFrame': '13 months (additional 1 month of safety follow-up after end of treatment).', 'description': 'Secondary safety endpoint.'}, {'measure': 'Occurrence of non-fatal myocardial infarction.', 'timeFrame': '13 months (additional 1 month of safety follow-up after end of treatment).', 'description': 'Secondary safety endpoint.'}, {'measure': 'Occurrence of non-fatal stroke.', 'timeFrame': '13 months (additional 1 month of safety follow-up after end of treatment).', 'description': 'Secondary safety endpoint.'}, {'measure': 'Occurrence of hypoglycaemia.', 'timeFrame': '13 months (additional 1 month of safety follow-up after end of treatment).', 'description': 'Secondary safety endpoint. Hypoglycaemia is defined as serum glucose level 3 mmol/l (\\<54 mg/dl) with coexisting related clinical symptoms.'}, {'measure': 'Occurrence of ionic disorders.', 'timeFrame': '13 months (additional 1 month of safety follow-up after end of treatment).', 'description': 'Secondary safety endpoint, defined as occurrence of:\n\n* Sodium plasma level of \\>150 mmol/L\n* Potassium plasma level of \\>6.0 mmol/L'}, {'measure': 'Occurrence of renal failure.', 'timeFrame': '13 months (additional 1 month of safety follow-up after end of treatment).', 'description': 'Secondary safety endpoint. Defined as:\n\n* sustained (i.e. \\>28 days) decline in eGFR ≥50% AND/OR\n* reaching end stage renal disease defined as:\n\n * sustained (i.e. \\>28 days) eGFR \\<15 mL/min/1.73 m2\n * chronic dialysis treatment\n * receiving a renal transplant AND/OR\n* renal death'}, {'measure': 'Occurrence of hypersensitivity to investigated drug.', 'timeFrame': '13 months (additional 1 month of safety follow-up after end of treatment).', 'description': 'Secondary safety endpoint. Any unexpected adverse drug reaction (UADR).'}, {'measure': 'Occurrence of allergic reactions.', 'timeFrame': '13 months (additional 1 month of safety follow-up after end of treatment).', 'description': 'Secondary safety endpoint. Any hypersensitivity reaction with proven immunological pathomechanism (types I-IV according to Coombs and Gell).'}, {'measure': 'Occurrence of infection.', 'timeFrame': '13 months (additional 1 month of safety follow-up after end of treatment).', 'description': 'Secondary safety endpoint. Any symptomatic infection (viral, bacterial or fungal).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['breast cancer', 'heart failure', 'ejection fraction', 'anthracyclines'], 'conditions': ['Breast Cancer', 'Heart Failure']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years and \\< 80 years.\n* Diagnosis of invasive breast cancer \\[stage I-III\\] and planned anthracycline treatment within 60 days.\n* Signed Informed Consent to participate in the study.\n\nExclusion Criteria:\n\n* Urinary tract infection with the need for treatment with an antibiotic 48 hours before the scheduled start of anthracycline treatment.\n* Recognised heart failure or symptoms which, in the opinion of the investigator may be a symptom of undiagnosed heart failure.\n* Left ventricular ejection fraction \\< 50% at the time of the screening.\n* Severe valvular heart disease.\n* A history of clinically significant arrhythmia, including atrial fibrillation regardless of type (at discretion of the investigator).\n* A history of stroke.\n* Cardiomyopathy: congenital, post-inflammatory, toxic, infiltrative (e.g. amyloidosis, sarcoidosis, haemochromatosis), postnatal or hypertrophic.\n* Pulmonary hypertension.\n* Uncontrolled arterial pressure or systolic pressure \\< 80 mmHg at screening (at the discretion of the investigator).\n* BMI \\> 40 kg/m2.\n* Diagnosed type 1 or type 2 diabetes or fasting glucose ≥ 126 mg/dl or HbA1C ≥ 6,5% (48 mmol/mol).\n* Pregnancy or breastfeeding.\n* Lack of compliance to use highly effective method of birth control.\n* Expected or possible treatment with epirubicin or liposomal doxorubicin within 12 months.\n* Taking another study drug or drugs from the group of SGLT2 inhibitors up to 6 months before the screening visit.\n* Taking semaglutide, liraglutide and metformin during the 30 days preceding the screening visit.\n* eGFR \\< 25 ml/min/1.73m2 according to CKD EPI.\n* Life expectancy \\< 12 months or cancer disease stage IV according to the TNM classification.\n* Alanine transaminase or aspartate transaminase levels above 2.5 times the local norm.\n* Anemia with Hemoglobin \\< 9 g/dl.\n* Kidney failure \\> G2 (according to KDIGO classification).\n* Liver disorders, Child-Pugh score \\> 4.\n* Known, active infections with HIV, HBV, HCV, tuberculosis.\n* Any other condition which, in the opinion of the investigator, makes it impossible to fulfill the requirements for participation in this study.'}, 'identificationModule': {'nctId': 'NCT06304857', 'acronym': 'PROTECTAA', 'briefTitle': 'CardioPROTECTion with Dapagliflozin in Breast Cancer Patients Treated with AnthrAcycline - PROTECTAA TRIAL', 'organization': {'class': 'OTHER', 'fullName': '4th Military Clinical Hospital with Polyclinic, Poland'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '2022/ABM/01/00039'}, 'secondaryIdInfos': [{'id': '2023-506631-15-00', 'type': 'OTHER', 'domain': 'EUCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dapagliflozin', 'description': 'Dapagliflozin 10 mg tablet orally once daily for 12 months', 'interventionNames': ['Drug: Dapagliflozin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo tablet matching dapagliflozin orally once daily for 12 months', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Dapagliflozin', 'type': 'DRUG', 'otherNames': ['Farxiga', 'Forxiga'], 'description': '10 mg tablet q.d', 'armGroupLabels': ['Dapagliflozin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'tablet matching dapagliflozin 10 mg q.d', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50-981', 'city': 'Wroclaw', 'state': 'Lower Silesian Voivodeship', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Bartosz Krakowiak, PhD, MD', 'role': 'CONTACT', 'email': 'bkrakowiak@4wsk.pl', 'phone': '+48 261 660 234'}], 'facility': '4th Military Clinical Hospital with Polyclinic', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '53-413', 'city': 'Wroclaw', 'state': 'Lower Silesian Voivodeship', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Rafał Matkowski, PhD, MD', 'role': 'CONTACT'}], 'facility': 'Lower Silesian Centre for Oncology, Lung Diseases and Hematology', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '04-141', 'city': 'Warsaw', 'state': 'Masovian Voivodeship', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Paweł Krzesiński, PhD, MD', 'role': 'CONTACT'}], 'facility': 'Military Medical Institute', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'centralContacts': [{'name': 'Bartosz Krakowiak, PhD, MD', 'role': 'CONTACT', 'email': 'bkrakowiak@4wsk.pl', 'phone': '+48 261 660 234'}], 'overallOfficials': [{'name': 'Waldemar Banasiak, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '4th Military Clinical Hospital with Polyclinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': '4th Military Clinical Hospital with Polyclinic, Poland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}