| advanced breast cancer (metastatic) | versus endocrine therapy alone ribociclib (LEE011) + letrozole superior to letrozole alone in terms of progression free survival in MONALEESA-2, 2016 (first line patients) | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| MONALEESA-2, 2016 | ribociclib (LEE011) + letrozole vs letrozole alone | progression free survival 0.56 [0.43; 0.72] median not reached vs. 14.7 mo Demonstrated | | |
| Trial | Treatments | Patients | Method |
|---|
| MONALEESA-2, 2016 | ribociclib
(600 mg per day on a 3-weeks-on, 1-week-off schedule) plus letrozole (2.5 mg per
day) (n=334) vs. placebo + letrozole (n=334) | postmenopausal women with HR-positive, HER2-negative recurrent
or metastatic breast cancer who had not received previous systemic therapy
for advanced disease | double-blind Parallel groups Sample size: 334/334 Primary endpoint: PFS FU duration: 18 months OS data were not mature at the time of the PFS interim analysis.
No treatment
crossover was allowed. |
|
