Effects of zoledronic acid and the association between its efficacy and γδT cells in postmenopausal women with breast cancer treated with preoperative hormonal therapy: a study protocolReport as inadecuate




Effects of zoledronic acid and the association between its efficacy and γδT cells in postmenopausal women with breast cancer treated with preoperative hormonal therapy: a study protocol - Download this document for free, or read online. Document in PDF available to download.

Journal of Translational Medicine

, 12:310

Clinical translation

Abstract

BackgroundAlthough the efficacy of zoledronic acid in postmenopausal women with breast cancer has been suggested, the underlying mechanism has not been fully clarified. Therefore, which patients may benefit from zoledronic acid and the optimal frequency of zoledronic acid administration are unclear. This study evaluates the effects of zoledronic acid on the tumor response in postmenopausal women with breast cancer and explores the relationship between its efficacy and γδ T cells.

Methods-designThis study is an open-label, multi-institutional, single-arm, phase II clinical trial. Zoledronic acid will be administered once during preoperative hormonal therapy with letrozole for 24 weeks in postmenopausal women with Estrogen Receptor ER-positive , Human Epidermal Growth Factor Receptor 2 HER2-negative, clinical T1 or T2 N0M0 breast cancer. The primary endpoint is the objective response rate measured by MRI at 12 and 24 weeks. The secondary endpoints are the associations between the frequency of Vγ2Vδ2 T cells before the administration of zoledronic acid and the objective response, the association between the frequency of Vγ2Vδ2 T cells and the Preoperative Endocrine Prognostic Index score, and the association between the frequency of Vγ2Vδ2 T cells and Ki67 MIB-1 index.

DiscussionThis study is designed to determine the add-on effect of zoledronic acid during preoperative hormonal therapy and to investigate the changes of the frequency of Vγ2Vδ2 T cells after the administration of zoledronic acid to explore the potential mechanism of zoledronic acid in breast cancer patients.

Trial registrationThis trial was registered at the UMIN Clinical Trials Registry as UMIN000008701.

KeywordsZoledronic acid Postmenopausal women Breast cancer γδ T cells Letrozole AbbreviationsEREstrogen receptor

HER2Human epidermal growth factor receptor 2

N-BPsNitrogen-containing bisphosphonates

IFN-γInterferon-γ

PEPIPreoperative endocrine prognostic index

IHCimmunohistochemistry

FISHFluorescence in situ hybridization

DISHDual color in situ Hybridization

ECOGEastern cooperative oncology group

ORRObjective response rate

CRComplete response

PRPartial response

RECISTResponse evaluation criteria in solid tumors

EUSOBIEuropean society of breast imaging

CTCAECommon terminology criteria for adverse events

Download fulltext PDF



Author: Eriko Sumi - Tomoharu Sugie - Kenichi Yoshimura - Harue Tada - Takafumi Ikeda - Eiji Suzuki - Yoshimasa Tanaka - Satoshi T

Source: https://link.springer.com/







Related documents