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Cancer Discov. 2017 Jun;7(6):561-574. doi: 10.1158/2159-8290.CD-17-0228. Epub 2017 May 11.

Neoadjuvant Trials in ER+ Breast Cancer: A Tool for Acceleration of Drug Development and Discovery.

Author information

1
Departments of Medicine and Cancer Biology; Breast Cancer Program, Vanderbilt-Ingram Cancer Center; Vanderbilt University Medical Center, Nashville, Tennessee.
2
Departments of Medicine and Cancer Biology; Breast Cancer Program, Vanderbilt-Ingram Cancer Center; Vanderbilt University Medical Center, Nashville, Tennessee. carlos.arteaga@vanderbilt.edu.

Abstract

Neoadjuvant therapy trials offer an excellent strategy for drug development and discovery in breast cancer, particularly in triple-negative and HER2-overexpressing subtypes, where pathologic complete response is a good surrogate of long-term patient benefit. For estrogen receptor-positive (ER+) breast cancers, however, use of this strategy has been challenging because of the lack of validated surrogates of long-term efficacy and the overall good prognosis of the majority of patients with this cancer subtype. We review below the clinical benefits of neoadjuvant endocrine therapy for ER+/HER2-negative breast cancer, its use and limitations for drug development, prioritization of adjuvant and metastatic trials, and biomarker discovery.Significance: Neoadjuvant endocrine therapy is an excellent platform for the development of investigational drugs, triaging of novel combinations, biomarker validation, and discovery of mechanisms of drug resistance. This review summarizes the clinical and investigational benefits of this approach, with a focus on how to best integrate predictive biomarkers into novel clinical trial designs. Cancer Discov; 7(6); 561-74. ©2017 AACR.

PMID:
28495849
PMCID:
PMC5497752
DOI:
10.1158/2159-8290.CD-17-0228
[Indexed for MEDLINE]
Free PMC Article

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