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A phase III multi-center, randomized, open-label trial to evaluate efficacy and safety of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone receptor-positive, HER2-negative early breast cancer (new adjuvant trial with ribociclib [LEE011]: NATALEE). NCT03701334

A randomized, open-label, phase 3 study of abemaciclib combined with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy alone in patients with high risk, node positive, early stage, hormone receptor positive, human epidermal receptor 2 negative, breast cancer. NCT03155997

Jones RH et al. Capivasertib (AZD5363) plus fulvestrant versus placebo plus fulvestrant after relapse or progression on an aromatase inhibitor in metastatic ER-positive breast cancer (FAKTION): A randomized, double-blind, placebo-controlled, phase II trial. ASCO 2019;Abstract 1006.

Lindeman G et al. Randomized phase II trial of venetoclax + fulvestrant versus fulvestrant in estrogen receptor+, HER2- locally advanced or metastatic breast cancer following recurrence or progression during or after a CDK4/6 inhibitor: VERONICA. ASCO 2019;Abstract TPS1108.

Martin M et al. Results from PEARL study (GEICAM/2013-02_CECOG/BC.1.3.006): A phase 3 trial of palbociclib (PAL) in combination with endocrine therapy (ET) versus capecitabine (CAPE) in hormonal receptor (HR)-positive/human epidermal growth factor receptor (HER) 2-negative metastatic breast cancer (MBC) patients (pts) whose disease progressed on aromatase inhibitors (AIs). San Antonio Breast Cancer Symposium 2019;Abstract GS2-07.

Mayer E et al. PALLAS: PAlbociclib Collaborative Adjuvant Study: A randomized phase 3 trial of palbociclib with adjuvant endocrine therapy versus endocrine therapy alone for HR+/HER2- early breast cancer. CTRC-AACR San Antonio Breast Cancer Symposium 2015;Abstract OT1-03-21.

PALbociclib CoLlaborative Adjuvant Study: A randomized phase III trial of palbociclib with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy alone for hormone receptor positive (HR+) / human epidermal growth factor receptor 2 (HER2)-negative early breast cancer. NCT02513394

Rastogi P et al. MonarchE: A randomized, open-label, phase 3 study of abemaciclib combined with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy alone in patients with high risk, node positive, early stage, HR+, HER2- breast cancer. San Antonio Breast Cancer Symposium 2017;Abstract OT3-05-05.

Rugo H et al. Alpelisib (ALP) + fulvestrant (FUL) in patients (pts) with PIK3CA-mutated (mut) hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC) previously treated with cyclin-dependent kinase 4/6 inhibitor (CDKi) + aromatase inhibitor (AI): BYLieve study results. ASCO 2020;Abstract 1006.

Slamon DJ et al. Neoadjuvant trastuzumab emtansine and pertuzumab in human epidermal growth factor receptor 2-positive breast cancer: Three-year outcomes from the phase III KRISTINE study. J Clin Oncol 2019;37(25):2206-16. Abstract

Sparano JA et al. Clinical and genomic risk to guide the use of adjuvant therapy for breast cancer. N Engl J Med 2019;380(25):2395-405. Abstract

Sparano JA et al. Adjuvant chemotherapy guided by a 21-gene expression assay in breast cancer. N Engl J Med 2018; 379(2):111-21. Abstract