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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) (ClinicalTrials.gov NCT01864746)

ER-positive (adjuvant)

III

PD 0332991 and Anastrozole for Stage 2 or 3 Estrogen Receptor Positive and HER2 Negative Breast Cancer (ClinicalTrials.gov 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 (ClinicalTrials.gov NCT017240427)

ER-positive (first-line advanced)

III

PD0332991/Paclitaxel in Advanced Breast Cancer (ClinicalTrials.gov 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 (ClinicalTrials.gov NCT01872260)

ER-positive (advanced/metastatic)

Ib/II

A Pharmacodynamics Pre-surgical Study of LEE011 in Early Breast Cancer Patients (MONALEESA-1) (ClinicalTrials.gov NCT01919229)

ER-positive (neoadjuvant)

II

Study of Efficacy and Safety of LEE011 in Postmenopausal Women with Advanced Breast Cancer (MONALEESA-2) (ClinicalTrials.gov NCT01958021)

ER-positive (advanced/metastatic)

II

  1. CDK, cyclin-dependent kinase; ER, estrogen receptor.