Table 2

Ongoing trials with preoperative or adjuvant CDK4/6 inhibitors in primary BC

Clinical trial.gov identifierTherapyPhasePatient characteristicsNumber of patientsPrimary end pointsEstimated study completion
Adjuvant
Palbociclib
NCT02040857Palbociclib + AI or tamoxifenIIHR+, HER2-
stage 2 or 3 (+ men)
160Treatment discontinuation rateJune 2019, recruiting
NCT18644746Palbociclib (13 cycles) +
Standard ET
Placebo +
Standard ET
III, PENELOPE-BHR+, HER2-
Residual invasive disease after neoadjuvant chemotherapy; adequate surgery
High CPS-EG score
1100Invasive DFSNovember 2023, recruiting
NCT02513394Palbociclib 2 years + standard ET
Standard ET
III, PALLASHR+, HER2-
Stage 2 or 3 (+men)
4600Invasive DFSSeptember 2025, recruiting
Presurgical
Palbociclib
NCT01709370Palbociclib + letrozole (16 weeks)IIOR+, HER2-
Postmenopausal tumour≥2 cm
Not T3N1, T4, N2 or N3
45RRNR, study status last verified October 2012
NCT01723774Anastrozole
+ goserelin (if premenopausal) +
palbociclib
IIOR+, HER2-
stage 2 or 3
29Complete cell cycle arrest in women without PIK3CA hot spot mutationFebruary 2016, recruiting
NCT02296801Letrozole
Letrozole → palbociclib +
letrozole
Palboclib → palbociclib
+letrozole
Palcociclib + letrozole
14 weeks
II, PALLET
neoadjuvant
OR+, HER2-postmenopausal
operable, tumour≥2 cm
306Proliferation (Ki67)January 2015, recruiting
NCT02400567FEC→ docetaxel
palbociclib + letrozole
II, NeoPAL Randomised,Luminal A + nodal involvement or luminal B
postmenopausal
stage −2–3A
132Number with residual tumour in breast or lymph nodeApril 2019, recruiting
Eudract number 2014-000809-12Palbociclib + standard ET
standard ET
II, PREDIXLumA (part of a translational study based of molecular subtypes)Luminal A >2 cm, no lymph node metastases200 (whole trial)pCRNR, recruiting
Eudract number 2014-000810-12Palbociclib + standard ET
standard ET
II, PREDIXLumB (part of a translational study based of molecular subtypes)Luminal B>2 cm and/or lymph node metastases200 (whole trial)pCRNR, recruiting
NCT02008734Control
palbociclib (125 m/day for 14 days)
Palbociclib (100 mg/d for 21 days)
II, POP
Randomised (3:1)
Untreated, operable early BC (≥15 mm)
Not candidate for neoadjuvant chemotherapy
105Antiproliferative responseJanuary 2016, recruiting
Abemaciclib
NCT02441946Abemaciclib + loperamide 2 weeks
Abemaciclib + loperamide + anastrozole 2 weeks
Anastrozole
2 weeks
Followed by
14 weeks abemaciclib + anastrozole + loperamide
II, NeoMONARCHER+, HER2-Postmenopausal tumour≥1 cm, ET deemed suitable220Ki67 expression at 2 weeksFebruary 2017, recruiting
Ribociclib
NCT01919229Ribociclib (400 mg) + letrozole
Ribociclib (600 mg) + letrozole
Letrozole
II, MONALEESA-1HR+, HER2-
Postmenopausal, tumour≥1.0 cm
14Cell cycle response rateCompleted, no results published
  • AI, aromatase inhibitor; BC, breast cancer; CPS-OG, clinical-pathological stage-oestrogen/grade score; ET, endocrine therapy; HR, hormone receptor; NR, not reported; pCR, pathological complete response; RR response rate; DFS, disease free survival.