Clinical trial • Phase II • Cardiology|Oncology

DAPAGLIFLOZIN for Breast cancer|Chemotherapy-induced cardiotoxicity

Phase II trial of DAPAGLIFLOZIN for Breast cancer|Chemotherapy-induced cardiotoxicity.

Overview

Trial Therapeutic Area
Cardiology|Oncology
Trial Disease
Breast cancer|Chemotherapy-induced cardiotoxicity
Trial Stage
Phase II
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
16-10-2024
First CTIS Authorization Date
03-12-2024

Trial design

Randomised, standard of care (no dapagliflozin); comparator details (drug/dose/schedule) not specified in available documents-controlled Phase II trial across 9 sites in Italy.

Randomised
Yes
Comparator
Standard of care (no dapagliflozin); comparator details (drug/dose/schedule) not specified in available documents
Target Sample Size
316
Trial Duration For Participant
548

Eligibility

Recruits 316 No vulnerable population selected. Participants are adult women between 18 and 70 years; informed consent is required (see inclusion item: "ECOG score 0-2Consent form signed."). No assent/parental consent procedures are described in the available data..

Pregnancy Exclusion
Currently pregnant (confirmed with positive pregnancy test performed from -7 to -1 days prior to start study drug) or unwilling to adopt highly effective contraceptive method
Vulnerable Population
No vulnerable population selected. Participants are adult women between 18 and 70 years; informed consent is required (see inclusion item: "ECOG score 0-2Consent form signed."). No assent/parental consent procedures are described in the available data.

Inclusion criteria

  • {"criterion_text":"- Chemotherapy-naive patients, scheduled for antracycline +/- trastuzumab treatment in the (neo-)adjuvant setting for stage I-III breast cancer"}
  • {"criterion_text":"- Adult women between 18 and 70 years of age"}
  • {"criterion_text":"- eGFR>25 ml/min/1.7 mq"}
  • {"criterion_text":"- ECOG score 0-2Consent form signed."}
  • {"criterion_text":"- Female patients of childbearing potential (not surgically sterilized and between menarche and 1 year post menopause) must have a negative result from a serum pregnancy test performed within 7 days of randomization and on the day of first study treatment prior to the initiation of study treatment. Women of childbearing potential must agree to use highly effective contraceptive measures from the time of informed consent through 7 months after last dose of study drug. Women of childbearing potential willing to use highly effective contraceptive measures from the time of informed consent through 7 months after last dose of study drug"}

Exclusion criteria

  • {"criterion_text":"- Left ventricular ejection fraction (LVEF) <53% (Current echocardiography recommendations set low normal value of 2D LVEF as 54% for women and 52% for men and hence in the 2016 EACVI position statement a reduction of LVEF below 53% was classified as abnormal)"}
  • {"criterion_text":"- Valvular heart disease"}
  • {"criterion_text":"- Previous malignancy requiring treatment with anthracyclines or chest radiotherapy"}
  • {"criterion_text":"- A life expectancy of ≤12 weeks"}
  • {"criterion_text":"- Currently pregnant (confirmed with positive pregnancy test performed from -7 to -1 days prior to start study drug) or unwilling to adopt highly effective contraceptive method"}
  • {"criterion_text":"- Currently breast-feeding women"}
  • {"criterion_text":"- History of hypersensitivity to dapagliflozin or any of the excipients of the product"}
  • {"criterion_text":"- History of Diabetic Ketoacidosis (DKA) requiring medical intervention (e.g. emergency room visit and/or hospitalization) within 1 month prior to enrolment visit"}
  • {"criterion_text":"- Type 1 diabetes mellitus"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- to assess whether the administration of dapagliflozin is associated with a lower rate of asymptomatic and symptomatic CTRCD during 18 months during a 18 months follow-up","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- to assess whether the administration of dapagliflozin is associated with a lower rate of asymptomatic CTRCD during 18 months","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
316
Recruitment Window Months
38
Consent Approach
Informed consent required; participants must sign consent form (documents listed: subject information and informed consent form documents L1_SIS and ICF). Participants are adults (18-70) so consent provided by participant. No details on assent or languages available are provided in the available documents.

Geography

Total Number Of Sites
9
Total Number Of Participants
316

Italy

Earliest CTIS Part Ii Submission Date
25-10-2024
Latest Decision Or Authorization Date
17-12-2025
Processing Time Days
418
Number Of Sites
9
Number Of Participants
316

Sites

Site Name
Istituto Tumori Bari Giovanni Paolo II
Department Name
Cardiology Unit
Principal Investigator Name
Stefano Oliva
Principal Investigator Email
Stefanoliva66@gmail.com
Contact Person Name
Stefano Oliva
Contact Person Email
Stefanoliva66@gmail.com
Site Name
Istituti Clinici Scientifici Maugeri S.p.A. Societa' Benefit In Forma Abbreviata Istituti Clinici Scientifici Maugeri S.p.A. Sb O Anche Ics Maugeri S.p.A. Sb O Maugeri S.p.A. Sb
Department Name
Cardiologia Riabilitativa
Principal Investigator Name
Giovanni Forni
Principal Investigator Email
giovanni.forni@icsmaugeri.it
Contact Person Name
Giovanni Forni
Contact Person Email
giovanni.forni@icsmaugeri.it
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
SC Cardiologia
Principal Investigator Name
Nicola Nicola
Principal Investigator Email
n.maurea@istitutotumori.na.it
Contact Person Name
Nicola Nicola
Contact Person Email
n.maurea@istitutotumori.na.it
Site Name
Azienda Unita' Sanitaria Locale Toscana Nord Ovest
Department Name
Cardiologia
Principal Investigator Name
Maria Laura Canale
Principal Investigator Email
marialaura.canale@uslnordovest.toscana.it
Contact Person Name
Maria Laura Canale
Site Name
Azienda Unita Sanitaria Locale Di Piacenza
Department Name
Cardiologia e UTIC
Principal Investigator Name
Andrea Tedeschi
Principal Investigator Email
a.tedeschi@ausl.pc.it
Contact Person Name
Andrea Tedeschi
Contact Person Email
a.tedeschi@ausl.pc.it
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
SS Cardiologica Clinica dell'Adulto
Principal Investigator Name
Alessandra Frattola
Contact Person Name
Alessandra Frattola
Site Name
Azienda Ospedaliera Ospedali Riuniti Marche Nord
Department Name
Cardio-oncology and Rare Diseases Unit
Principal Investigator Name
Federico Guerra
Principal Investigator Email
Federico.guerra@ospedaliriuniti.marche.it
Contact Person Name
Federico Guerra
Site Name
Alessandro Manzoni Hospital
Department Name
UO Cardiologia
Principal Investigator Name
Giuseppe Uccello
Principal Investigator Email
gi.uccello@asst-lecco.it
Contact Person Name
Giuseppe Uccello
Contact Person Email
gi.uccello@asst-lecco.it
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
SC Cardiologia 1
Principal Investigator Name
Laura Scelsi
Principal Investigator Email
l.scelsi@smatteo.pv.it
Contact Person Name
Laura Scelsi
Contact Person Email
l.scelsi@smatteo.pv.it

Sponsor

Primary sponsor

Full Name
Fondazione IRCCS Policlinico San Matteo
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Italy

Investigational products

Investigational Product Name
Forxiga 10 mg film-coated tablets
Active Substance
DAPAGLIFLOZIN
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Authorised (marketing authorisation EU/1/12/795/007)
Starting Dose
10 mg
Dose Levels
10 mg
Frequency
Once daily
Maximum Dose
10 mg/day

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