Phase
Condition
Breast Cancer
Cancer
Treatment
Acquisition of a digitized ECG by four modalities within 20 minutes
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adult female patients requiring start of ribociclib based therapy for a breastcancer in their standard of care, as per their summary of product characteristic'sindications
Association with hormone-based therapy in combination is authorized (aromataseinhibitors or fulvestrant)
Able to provide an informed consent
Exclusion
Exclusion Criteria:
Any allergy or contra-indication to ribociclib as mentioned in their as summary ofproduct characteristic's
Patients presenting a condition precluding accurate QTc measurements onelectrocardiogram, i.e paced ventricular rhythm, multiples premature ventricular orsupra-ventricular contractions, ventricular tachycardia, supraventricular arrhythmia (including atrial fibrillation, flutter or junctional rhythm)
Patients with an atrial pacing and sinus dysfunction
Patients presenting a contra-indication for ECG measurement, or with a devicerendering ECG measurements impossible (i.e. Diaphragmatic pacing)
Patients presenting a contra-indication to ribociclib start; including associationwith prohibited drug potentializing the risk of TdP
Study Design
Connect with a study center
Groupe Ambroise Paré, Hartmann
Neuilly-sur-Seine, 92200
FranceActive - Recruiting
CIC - Hôpitaux Universitaires Pitié Salpêtrière, Paris, FRANCE
Paris, 75651
FranceActive - Recruiting
Hôpital Tenon
Paris, 75020
FranceActive - Recruiting
Institut Gustave Roussy
Villejuif, 94805
FranceActive - Recruiting
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