Pathologic and molecular responses to neoadjuvant trastuzumab and/or lapatinib from a phase II randomized trial in HER2-positive breast cancer (TRIO-US B07)

Nature Communications
Sara HurvitzDennis J Slamon

Abstract

In this multicenter, open-label, randomized phase II investigator-sponsored neoadjuvant trial with funding provided by Sanofi and GlaxoSmithKline (TRIO-US B07, Clinical Trials NCT00769470), participants with early-stage HER2-positive breast cancer (N = 128) were recruited from 13 United States oncology centers throughout the Translational Research in Oncology network. Participants were randomized to receive trastuzumab (T; N = 34), lapatinib (L; N = 36), or both (TL; N = 58) as HER2-targeted therapy, with each participant given one cycle of this designated anti-HER2 therapy alone followed by six cycles of standard combination chemotherapy with the same anti-HER2 therapy. The primary objective was to estimate the rate of pathologic complete response (pCR) at the time of surgery in each of the three arms. In the intent-to-treat population, we observed similar pCR rates between T (47%, 95% confidence interval [CI] 30-65%) and TL (52%, 95% CI 38-65%), and a lower pCR rate with L (25%, 95% CI 13-43%). In the T arm, 100% of participants completed all protocol-specified treatment prior to surgery, as compared to 69% in the L arm and 74% in the TL arm. Tumor or tumor bed tissue was collected whenever possible pre-treatment (N = 110), a...Continue Reading

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Citations

Apr 20, 2021·Therapeutic Advances in Medical Oncology·Jie ZhangChuangui Song
May 6, 2021·PloS One·Jason J ZoellerJoan S Brugge
May 14, 2021·Breast Cancer Research and Treatment·A J EustaceB T Hennessy
Jun 11, 2021·JCO Oncology Practice·Sonia Pernas, Sara M Tolaney
Jun 20, 2021·Cancer Research·Li-Chung TsaoZachary C Hartman

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Methods Mentioned

BETA
xenograft
biopsies
biopsy
surgical resection
proteomic profiling
contraception
electrophoresis
Feature Extraction
chip

Clinical Trials Mentioned

NCT00769470

Software Mentioned

immunoStates MetaIntegrator
R
CIBERSORT
ssGSEA
sva
GSEABase
Aperio ImageScope
immunoStates
Limma
GeparSixto

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