A Deep Learning Method to Evaluate QT on Ribociclib

RecruitingOBSERVATIONAL
Enrollment

70

Participants

Timeline

Start Date

July 28, 2023

Primary Completion Date

May 28, 2026

Study Completion Date

September 28, 2026

Conditions
Breast CancerRibociclib
Interventions
OTHER

Acquisition of a digitized ECG by four modalities within 20 minutes

"Patients will have three visits during the cycle for a given dose (600mg/day, 400mg/day or 200mg/day): Baseline , Day 14, Day 28~At each visit, the patient will have the acquisition of a digitized ECG by four modalities within 20 minutes (A 10 second triplicate ECG with WELCH-ALYN ELI-280® with the three 10 sec ECGs collected at approximatively 2-minute intervals, 3 min holter acquisition with a CGM HI-patch ®, a 3 minutes acquisition with AliveCore 6L® device and 10 seconds triplicate acquisition with QT-medical ® device collected at approximatively 2-minute intervals ).~Concomitantly with the ECG acquisition, patients will have blood sampling for measurements of variables clinically important for assessment of QTc including potassium, fasting blood glucose, calcemia, magnesium, estradiol, progesterone, FSH, LH, D4-androstenedione, total and free testosterone, SHBG and TSH. Blood concentration of ribociclib will be also assessed."

Trial Locations (4)

75020

RECRUITING

Hôpital Tenon, Paris

75651

RECRUITING

CIC - Hôpitaux Universitaires Pitié Salpêtrière, Paris, FRANCE, Paris

92200

RECRUITING

Groupe Ambroise Paré, Hartmann, Neuilly-sur-Seine

94805

RECRUITING

Institut Gustave Roussy, Villejuif

All Listed Sponsors
lead

CMC Ambroise Paré

OTHER