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abemaciclib plus aromatase inhibitor (n=328) vs. aromatase inhibitor (n=165)
randomized controlled trial
abemaciclib plus a nonsteroidal aromatase inhibitor
abemaciclib: PO 150mg twice daily during each 28-day cycle / anastrozole 1mg PO or letrozole 2.5mg PO during each 28-day cycle
placebo plus a nonsteroidal aromatase inhibitor
anastrozole 1mg PO or letrozole 2.5mg PO during each 28-day cycle
la/mBC - HR-positive - 1st line (L1)
double blind
158 sites in 22 countries
P3 / PFS at 1-sided at 0.025, with 1 IA (alpha=0.00025) and final with the rest of the alpha. / OS will be tested hierarchically (with 3 IA)
abemaciclib plus endocrine therapy (n=2808) vs. endocrine therapy (n=2829)
randomized controlled trial
abemaciclib plus endocrine therapy
abemaciclib: 150mg 2/day
endocrine therapy
la/mBC - HR-positive - 1st line (L1)
Exclusion criteria: Patients with occult breast cancer, metastatic disease, or node-negative breast cancer, and, after a protocol amendment, patients with inflammatory breast cancer, who received treatment with ET for breast cancer prevention, raloxifene, and/or a CDK4/6 inhibitor and with venous thromboembolic events
open label
603 sites in 38 countries (worldwide)
P3 / IDFS at 1-sided at 0.025 with 2 IA (1st IA at 0.0015, 2nd IA at 0.0092 and final analysis at 0.0220 all at 1-sided)
Adding abemaciclib to endocrine therapy increased significantly the IDFS in patients with HR-positive, and HER-negative
palbociclib plus endocrine therapy (n=628) vs. endocrine therapy (n=616)
randomized controlled trial
palbociclib plus endocrine therapy according to local standars (physician's choice)
palbociclib: PO 125mg/day for 21 days
placebo plus endocrine therapy according to local standars (physician's choice)
la/mBC - HR-positive - 1st line (L1)
double blind
221 sites and 11 countries (Australia, Asia, Europe, USA
P3 / IDFS at 5% with 2 IA for efficacy -> 1st <0.0002, 2nd <0.0120 and final analysis <0.0463 / adjustment for multiple testing in other tests was not planned
Palbociclid did not improve IDFS compare to placebo for patients with HR-positive / HER2-negative breast cancer
palbociclib plus letrozole (n=84) vs. letrozole (n=81)
randomized controlled trial
palbociclib plus letrozole
palbociclib: PO 125mg once daily for 3 weeks followed by 1 week off in 28-day cycles / letrozole: PO 2.5mg once daily
letrozole
letrozole: PO 2.5mg once daily
la/mBC - HR-positive - 1st line (L1)
open label
50 sites in 12 countries (Canada, Europe, South Africa, South Korea)
P2 / analysis of the primary endpoint was initially intendedto be based on cohort 2 only, but an unplanned interim analysis was done in cohort 1 and amended (prospectively) the statistical analysis plan such that the primary endpoint would be analysed in cohorts 1 and 2 combined instead of cohort 2 alone/ PFS at 1-sided at 0.1
palbociclib plus letrozole (n=444) vs. letrozole (n=222)
randomized controlled trial
palbociclib plus letrozole
palbociclib : PO 125mg per day, in 4-weeks cycle (3-weeks on and 1-week off) / letrozole: PO 2.5mg per day
placebo plus letrozole
letrozole: PO 2.5mg per day
la/mBC - HR-positive - 1st line (L1)
double blind
186 sites in 17 countries
P3 / PFS will be tested at 1-sided at 0.025 (with 1 IA at 0.000013, and 0.025 at the final analysis) / hierarchically test for OS
ribociclib plus letrozole (n=334) vs. letrozole (n=334)
randomized controlled trial
ribociclib plus letrozole
ribociclib: PO 600mg/day on a 3-weeks-on, 1-week-offin 28-day cycle / letrozole: mg/day every day
placebo plus letrozole
letrozole: mg/day every day
la/mBC - HR-positive - 1st line (L1)
Exclusion criteria: previous CDK4/6 inhibitor or any previous systemic chemotherapy or endocrine therapy for advanced disease, previous neoadjuvant or adjuvant therapy with a nonsteroidal aromatase inhibitor was not allowed, unless the disease-free interval was more than 12 months, CNS metastases
double blind
29 countries at 223 trial centers
P3 / PFS at 1-sided at 2.5 with 1 IA (less than p=1.29×10^(-5) and the final analysis at p=0.02499) then for OS if PFS is significant, at 1-sided at 2.5%, with 4 IA
Adding ribociclib to letrozole increased significantly PFS
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