Table 5

Ongoing trials with CDK 4/6 inhibitors in ABC

Clinical identifier
Therapy Phase Patient characteristics Number of patients Line of therapy Chemotherapy for MBC Primary end points Estimated study completion
NCT01684215PalbociclibI/IIOR+, HER2-Japanese, phase I: solid tumours
Phase II: postmenopausal, OR+, HER2-
58First lineNoneDLT
1-year PFS
January 2017, recruiting
NCT01976169Palbociclib + trastuzumab-DM1
IHER2+, ABC, prior trastuzumab
Rb-proficient (Rb normal and low p16in4a)
17No criteriaNo criteriaDLTAugust 2015, recruiting
NCT023844239Palbociclib (100 mg) + fulvestrant or tamoxifen
Palbociclib (125 mg) + fulvestrant or tamoxifen
± LHRH agonist
IIHR+, HER2-postmenopausal, MBC or LABC70Previous treatment with PI3Kinhibitor mTOR inhibitor, no limitations in lines≤2 prior linesPD (16 weeks)August 2017 (not initiated March 2015)
Eudract database 2011-005637-38Palbociclib
Palbociclib + ETto which the patients had progressed
Postmenopausal50≥1 line ET; PD on ET≤1Clinical benefitNR
NCT02448420Palbociclib + trastuzumab ± (letrozole)II, PATRICIAOR+ and OR-138≥2 lines of HER2-directed therapyNo criteriaPFS, 6 monthsDecember 2019
NCT02297438Palbociclib + letrozole
Placebo + letrozole
III, PALAMO-4Asian, OR+, HER2-postmenopausal,≥12 months from adjuvant NSAI330first lineNonePFSOctober 2017, recruiting
NCT02028507Palbociclib + exemestane
III, PEARLPostmenopausal, MBC, resistant NSAI348First or Second line≤1PFSJanuary 2018
NCT02333370Ribociclib + letrozoleIb/IIHR+, HER2-Postmenopausal ABC112First lineNonePFS (phase II)February 2021, recruiting
NCT01857193Ribociclib + everolimus + exemestane
Ribociclib + exemestane
Everolimus + exemestane
Ib/IIOR+, HER2-postmenopausal, LABC or MBC, adj NSAI185First line≤1Phase Ib: DLT
Phase II: PFS
May 2016, recruiting
NCT01872260Ribociclib + letrozole
BYL719 (PI3K-α inhibitor) + letrozole
Ribociclib + BYL719 + letrozole
Ib/IIER+, HER2-Postmenopausal, LABC or MBC,300Ib dose escalation: ≥ first line
Ib dose expansion: first line
II: first line
Ib dose escalation: 1
Ib dose expansion: 0
II: 0.
Phase Ib: DLT
Phase II: PFS
May 2017, recruiting
NCT02088684Ribociclib + fulvestrant
Ribociclib + BYL719 + fulvestrant
Ribociclib + BKM120 (PI3K-pan-inhibitor)+ fulvestrant
Ib/IIHR+, HER2-postmenopausal, LABC or MBC,216Ib:≤2
Phase Ib: ≥first line
Phase II: ≥first line
Phase Ib: DLT
Phase II: PFS
February 2019, recruiting
NCT01958021Ribociclib + letrozole
Placebo + letrozole
III, MONALEESA-2Postmenopausal,
650first lineNonePFSAugust 2017, recruiting
NCT02422615Ribociclib + fulvestrant
Placebo + fulvestrant
III, MONALEESA-3HR+, HER2-Postmenopausal
660first or second lineNonePFSMay 2020, not yet open
NCT02278120Ribociclip + anastrozole/tamoxifen + goserelin
Placebo + NSAI/tamoxifen + goserelin (double-blind)
III, MONALEESA-7HR+, HER2-ABC, premenopausal or perimenopausal660first lineNonePFSFebruary 2018, recruiting
NCT02107703Abemaciclib + fulvestrant
Placebo + fulvestrant
III, MONARCH 2Postmenopausal, LABC or MBC, HR+, HER2-630First or Second lineNonePFSFebruary 2020, recruiting
NCT02246621Abemaciclib + anastrozole/letrozole
Placebo + anastrozole/letrozole
III, MONARCH 3HR+, HER2-postmenopausal LABC or MBC, HR+, HER2-450First lineNonePFSJuly 2021, recruiting
NCT02057133Abemaciclib + letrozole
Abemaciclib + anastrozole
Abemaciclib + tamoxifen
Abemaciclib + exemestane
Abemaciclib (two doses) + exemestane + everolimus
Abemaciclib (two doses) + trastuzumab
LHRH agonist
Doses NR
IMBC, HR+, HER2- or HER2+ (trastuzumab)102First line
≥ second line depending on combination
≥1Number with drug-related AENovember 2016, recruiting
Eudract number 2014-004010-28Abemaciclib ± ET ± trastuzumabIIHR+, brain metastases120No criteriaNo criteriaInracranial RRNR, ongoing
  • ABC, advanced breast cancer; AE, adverse event; ET, endocrine therapy; OR, oestrogen receptor; HR, hormone receptor; LABC, locally advanced breast cancer; MBC, metastatic breast cancer; NR, not reported; NSAI, non-steroidal aromatase inhibitor; PD, progressive disease, PFS, progression-free survival; RR, response rate.