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Table 2 Currently registered clinical studies with CDK4/6 inhibitors in breast cancer

From: Targeting the cyclin-dependent kinases (CDK) 4/6 in estrogen receptor-positive breast cancers

Compound Setting Trial primary endpoint Combination N Phase identifier
Palbociclib (PD-0332991) First-line metastatic PFS Letrozole 450 III NCT01740427 (PALOMA-2)
  Metastatic PFS Fulvestrant 417 III NCT01942135 (PALOMA-3)
  High-risk adjuvant iDFI Anti-hormonal 800 III NCT01864746 (PENELOPE-B)
  Neo-adjuvant pCR Anastrozole 29 II NCT01723774
  Pre-operative ORR Letrozole 45 II NCT01709370
  Metastatic MTD Paclitaxel 20 I NCT01320592
  Neo-adjuvant Biomarker cCR Letrozole 306 II NCT02296801 (PALLET)
  Metastatic PFS Exemestane versus capecitabine 348 III NCT02028507 (PEARL)
  Adjuvant Treatment discontinuation Letrozole 160 II NCT02028507
  Metastatic Dose/toxicity TDM-1 17 Ib NCT01976169
  Neoadjuvant RCB Letrozole versus FEC-3 132 II NCT02400569 (NeoPAL)
  Adjuvant iDFS SAT 4600 III NCT02513394 (PALLAS)
Ribociclib (LEE011) First-line metastatic PFS Letrozole 450 III NCT01958021
  Pre-surgical PD Letrozole 120 II NCT01919229 (MONALEESA-1)
  Metastatic DLT, PFS BYL719, letrozole 300 I/II NCT01872260
  Metastatic DLT, PFS Exemestane, everolimus 185 Ib/II NCT01857193
  Metastatic PFS Letrozole 650 III NCT01958021 (MONALEESA-2)
  Metastatic DLT Letrozole, buparlisib 13 I NCT02154776
  Metastatic (pre-menopausal) PFS Tamoxifen, NSAI 660 III NCT2278120 (MONALEESA-7)
  Metastatic DLT/PFS BYL719a or BKM120 216 I/II NCT01872260
  Metastatic PFS Fulvestrant 660 III NCT02422615 (MONALEESA-3)
Abemaciclib (LY2835219) Neoadjuvant Biomarker Anastrozole 220 II NCT02441946 (NeoMONARCH)
  Brain metastasis Response Single agent 120 II NCT02308020
  Metastatic PFS NSAI 450 III NCT02246621 (MONARCH-3)
  Metastatic Response Single agent 128 II NCT021024490 (MONARCH-1)
  Metastatic PFS Fulvestrant 630 III NCT02107703 (MONARCH-2)
  Metastatic PFS NSAI, tamoxifen, exemestane, everolimus, trastuzumab 102 I NCT02057133
  1. aBYL719 (Novartis) is a phosphoinositide 3-kinase α-specific inhibitor. cCR clinical complete response, DLT dose limiting toxicity, FEC 5-fluorouracil, epirubicin, cyclophosphamide; iDFS invasive disease-free interval, MTD maximum tolerated dose, NSAI non-steroidal aromatase inhibitor, ORR objective response rate, pCR pathologic complete response rate, PD pharmacodynamic, PFS progression-free survival, RCB residual cancer burden, SAT standard adjuvant therapy, TDM-1 ado-trastuzumab emtansine