70
Participants
Start Date
July 28, 2023
Primary Completion Date
May 28, 2026
Study Completion Date
September 28, 2026
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."
RECRUITING
Hôpital Tenon, Paris
RECRUITING
CIC - Hôpitaux Universitaires Pitié Salpêtrière, Paris, FRANCE, Paris
RECRUITING
Groupe Ambroise Paré, Hartmann, Neuilly-sur-Seine
RECRUITING
Institut Gustave Roussy, Villejuif
CMC Ambroise Paré
OTHER