NATALEE

Primary
To compare invasive disease-free survival (iDFS) for ribociclib + ET
versus + ET in patients with HRpositive, HER2-negative, EBC

Secondary
1. To evaluate the two treatment groups with respect to recurrence-free survival (RFS)
2. To evaluate the two treatment groups with respect to distant disease free survival (DDFS)
3. To evaluate the two treatment groups with respect to overall survival (OS)
4. To evaluate patients reported outcomes for health-related quality of life in the two treatment groups
5. To evaluate safety and tolerability of the treatment regimen

Exploratory
1. To explore the two treatment groups with respect to loco-regional
recurrence-free survival (LRRFS)
2. To explore use of subsequent antineoplastic therapy
3. To explore hospitals resource utilization
4. To explore prognostic and predictive biomarkers of treatment with ribociclib and ET
5. To explore potential molecular mechanisms of resistance to treatment of ribociclib and ET
6. To explore the role of ctDNA/ctRNA (circulating tumor DNA/RNA) for their suitability to monitor and predict disease recurrence

Voir le protocole Histoire médicale
Poids et taille
Examen physique
Signes vitaux
Tomodensitométrie
Scintigraphie osseuse
Mammographie
Électrocardiogramme
Prises de sang
Analyse d’urine
Questionnaires (qualité de vie, le bien-être)