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Table 1 Trials of CDK4/6 inhibitors in breast cancer

From: Retinoblastoma tumor suppressor pathway in breast cancer: prognosis, precision medicine, and therapeutic interventions

Trial of CDK4/6 agent Target disease Trial phase
PD-0332991/Palbociclib (Pfizer; New York, NY, USA)   
A Study of Palbociclib in Addition to Standard Endocrine Treatment in Hormone Receptor Positive Her2 Normal Patients with Residual Disease after Neoadjuvant Chemotherapy and Surgery (PENELOPE-B) ( NCT01864746) ER-positive (adjuvant) III
PD 0332991 and Anastrozole for Stage 2 or 3 Estrogen Receptor Positive and HER2 Negative Breast Cancer ( NCT01723774) ER-positive (neoadjuvant) II
A Study of PD-0332991 + Letrozole vs. Letrozole for 1st Line Treatment of Postmenopausal Women with ER+/HER2- Advanced Breast Cancer ( NCT017240427) ER-positive (first-line advanced) III
PD0332991/Paclitaxel in Advanced Breast Cancer ( NCT01320592) All metastatic Ib
LEE011 (Novartis; New York, NY, USA)   
Phase Ib/II Trial of LEE011 with Everolimus (RAD001) and Exemestane in the Treatment of ER+Her2- Advanced Breast Cancer ER-positive (advanced/metastatic) Ib/II
Study of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer ( NCT01872260) ER-positive (advanced/metastatic) Ib/II
A Pharmacodynamics Pre-surgical Study of LEE011 in Early Breast Cancer Patients (MONALEESA-1) ( NCT01919229) ER-positive (neoadjuvant) II
Study of Efficacy and Safety of LEE011 in Postmenopausal Women with Advanced Breast Cancer (MONALEESA-2) ( NCT01958021) ER-positive (advanced/metastatic) II
  1. CDK, cyclin-dependent kinase; ER, estrogen receptor.