Advanced HR+ breast cancer
Conditions
Brief summary
Incidence of Dose Limiting Toxicities (DLTs) in Cycle 1 - Phase lb only [Time Frame: 28 days], Adverse Events (AEs), serious AEs (SAEs), changes in hematology and chemistry values, vital signs, electrocardiograms (ECGs), dose interruptions, reductions and dose intensity., Plasma concentration-time profiles of LEE011, letrozole. PK parameters, including but not limited to AUC0-24h, Cmin, Cmax, Tmax, accumulation ratio (Racc).
Detailed description
Plasma concentration-time profiles of LEE011, BYL719 and letrozole. PK parameters, including but not limited to AUC0-24h, Cmin, Cmax, Tmax, accumulation ratio (Racc)., Tumor response per RECIST v1.1 (by local investigator assessment): Overall Response Rate (ORR), Disease Control Rate (DCR), Clinical benefit Rate (CBR), Duration of Response (DOR) and Progression Free Survival (PFS) CBR is defined as CR, PR, or SD lasting 24 weeks or longer., Incidence of grade 3 or 4 hyperglycemia, Incidence of grade 3 or 4 AST/ALT elevations
Interventions
DRUGALPELISIB
DRUGLEE011
DRUGRIBOCICLIB
DRUGLETROZOLE
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Dose Limiting Toxicities (DLTs) in Cycle 1 - Phase lb only [Time Frame: 28 days], Adverse Events (AEs), serious AEs (SAEs), changes in hematology and chemistry values, vital signs, electrocardiograms (ECGs), dose interruptions, reductions and dose intensity., Plasma concentration-time profiles of LEE011, letrozole. PK parameters, including but not limited to AUC0-24h, Cmin, Cmax, Tmax, accumulation ratio (Racc). | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma concentration-time profiles of LEE011, BYL719 and letrozole. PK parameters, including but not limited to AUC0-24h, Cmin, Cmax, Tmax, accumulation ratio (Racc)., Tumor response per RECIST v1.1 (by local investigator assessment): Overall Response Rate (ORR), Disease Control Rate (DCR), Clinical benefit Rate (CBR), Duration of Response (DOR) and Progression Free Survival (PFS) CBR is defined as CR, PR, or SD lasting 24 weeks or longer., Incidence of grade 3 or 4 hyperglycemia, Incidence of grade 3 or 4 AST/ALT elevations | — |
Countries
France, Spain
Outcome results
None listed