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abemaciclib plus endocrine therapy (n=2808) vs. endocrine therapy (n=2829)
randomized controlled trial
abemaciclib plus endocrine therapy
abemaciclib: 150mg 2/day
endocrine therapy
breast cancer - adjuvant
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 (n=2884) vs. endocrine therapy (n=2877)
randomized controlled trial
breast cancer - adjuvant
open label
406 centers in 21 countries (worldwide)
P3 / IDFS at 1-sided at 0.025, wit 2 IA (1st: 0.0001, 2nd: 0.0060, final 0.0231) / All statistical inferences for secondary efficacy and patient safety will use two-sidedalpha = 0.05 without adjustment for multiplicity and without applying a sequentialtesting procedure
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)
breast cancer - adjuvant
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 endocrine therapy (n=92) vs. capecitabine (n=86)
randomized controlled trial
palbociclib plus exemestane
palbociclib: PO 125mg/day for 3weeks / exemestane: 25mg/day for 4weeks / leuprolide: SC 3.75mg
capecitabine
capecitabine: 1250 mg/m² twice a day for 2 weeks, repeated every 3 weeks
la/mBC - HR positive
open label
14 sites in South Korea
P2 / PFS at 1-sided at 0.05 with 1 IA : IA at 0.0055 (-sided) and final analysis at 0.0485 ->However, the plan had to be changed to no interim analysis because of the high accrual rate on Sept 27, 2018
Exploratory results: it seems that palbociclib plus endocrine therapy increase PFS in premenopausal women with HR-positive metstatic breast cancer
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)
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
abemaciclib plus fulvestrant (n=446) vs. fulvestrant (n=223)
randomized controlled trial
abemaciclib plus fulvestrant
abemaciclib: 150mg twice per day, during each 28-days cycle (after amendment for reducing 200mg twice a day) / fulvestrant: IM 500mg on days 1 and 15 of the first cycle, and then the first day of each cycle
placebo plus fulvestrant
fulvestrant: IM 500mg on days 1 and 15 of the first cycle, and then the first day of each cycle
la/mBC - HR-positive - 2nd line (L2)
double blind
P3 / hierarchical testing approach, with first PFS at 1-sided at 0.025, with 1 IA (with alpha at 0.00001) and final analysis at alpha at 0.02499996, and then OS, with 3 IA.
dalpiciclib plus fulvestrant (n=241) vs. fulvestrant (n=120)
randomized controlled trial
dalpiciclib plus fulvetrant
dalpiciclib: PO 150mg/day for 3-weeks on and 1-week off in each 4-cycle / fulvestrant: IM 500mg on day 1 and 15 of the first cycle and on day 1 of each subsequent 4-week cycle.
placebo (matching dulpaciclib) plus fulvestrant
fulvestrant: IM 500mg on day 1 and 15 of the first cycle and on day 1 of each subsequent 4-week cycle.
la/mBC - HR-positive - 2nd line (L2)
double blind
39 centers in China
P3 / 1-sided at 0.025 for PFS with 1IA (α = 0.0074 ) and final analysis (α = 0.0227)
dalpiciclib added to fuvestrant improved significantly PFS compate to fulvestrant alone, in patients with HR-positive, and HER2-negaive BC.
palbociclib plus fulvestrant (n=94) vs. fulvestrant (n=95)
randomized controlled trial
palbociclib plus fulvestrant
palbociclib: 125 mg/day, 28-day cycles; 3 weeks on, 1 week off / fulvestrant: 500 mg on days 1, 14, 28, and every 28 days onward
placebo plus fulvestrant
fulvestrant: 500 mg on days 1, 14, 28, and every 28 days onward
la/mBC - HR-positive - 2nd line (L2)
double blind
32 institutions in 2 countries
P2 / PFS at 2-sided at 0.02 / no IA
palbociclib plus fulvestrant (n=347) vs. fulvestrant (n=174)
randomized controlled trial
palbociclib plus fulvestrant
palbociclib: PO 125mg/day 3weeks in/1week off / fulvestrant: IM 500mg
placebo plus fulvestrant
fulvestrant: IM 500mg
Premenopausal or perimenopausal patients received goserelin for the duration of study treatment, starting at least 4 weeks before randomization and continuing every 28 days.
la/mBC - HR-positive - 2nd line (L2)
double blind
144 centers in 17 countries (Asia, Australia, Europe, North America)
P3 / PFS at 1-sided at 0.025 with 1 IA (at 0.00135) / hierarchical test for OS with 2IA
ribociclib plus endocrine therapy (n=335) vs. endocrine therapy (n=337)
randomized controlled trial
ribociclib plus endocrine therapy plus goserelin
ribociclib: PO 600mg/day (3-weeks-on and 1-week-off) / endocrine therapy: tamoxifen (PO 20 mg) or anNSAI (letrozole 2.5 mg or anastrozole 1 mg) every day / goserelin: SC 3.6mg on day 1 of every cycle
placebo plus endocrine therapy plus goserelin
endocrine therapy: tamoxifen (PO 20 mg) or anNSAI (letrozole 2.5 mg or anastrozole 1 mg) every day / goserelin: SC 3.6mg on day 1 of every cycle
la/mBC - HR-positive - 2nd line (L2)
Exclusion criteria: patients who had received previous treatment with a CDK4/6 inhibitors, who had previous endocrine therapy in advanced setting, who had CNS metastases
double blind
188 centres in 30 countries
P3 / PFS at 1-sided at 2.5% (no IA), then if PFS is significant, testing of OS with 2 IA at 1-sided at 2.5%
PFS was significantly increased when ribociclib was added to endocrine therapy
ribociclib plus fulvestrant (n=484) vs. fulvestrant (n=242)
randomized controlled trial
ribociclib plus fulvestrant
ribociclib: PO 600mg per day, 3-weeks on and 1-week off / fulvestrant: IM 500mg on day 1 of each 28-day cycle with an additional dose on day 15 of cycle 1
placebo plus fulvestrant
fulvestrant: IM 500mg on day 1 of each 28-day cycle with an additional dose on day 15 of cycle 1
la/mBC - HR-positive - 2nd line (L2)
Exclusion criteria: previsous treatment with fulvestrant or CDK4/6 inhibitors
double blind
174 study sites in 30 countries
P3 / PFS at 1-sided at 0.025 (with no IA) / hierarchical testing strategy for OS at 1-sided at 0.025 (1st IA: 0.00013, 2nd IA: 0.01129, final analysis)
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