Clinical Trials

JBCRG-10TR

Translational research for JBCRG-10 ("A randomized phase II comparative study of preoperative chemotherapies including Trastuzumab + Cyclophosphamide + Docetaxel for operable HER2 positive breast cancer")

Status
No Longer Recruiting

Objectives
Identification of a molecular marker to predict the therapeutic effect and a marker for "A randomized phase II comparative study of preoperative chemotherapies including Trastuzumab + Cyclophosphamide + Docetaxel for operable HER2 positive breast cancer."

Subjects
Among the patients who participated in the “A randomized phase II comparative study of preoperative chemotherapies including Trastuzumab + Cyclophosphamide + Docetaxel for operable HER2 positive breast cancer”, those who submitted tumor tissue and blood samples for this study.

(1) Tissues collected by needle biopsy before starting treatment (mRNA expression, protein expression) (2) Surgical sample taken after completing treatment (mRNA expression, protein expression) (3) Blood collected before, during and after treatment (cancer-associated cells in the circulating blood (e.g. CEC) protein expression)

Endpoints
(1) Basal-like marker (2) Capecitabine metabolic marker (3) Expression of molecules associated with cell proliferation and cell death (4) Expression of molecules involved in cell infiltration (5) Expression of angiogenic molecules (6) Expression of stem cell-related molecules (7) Analysis of vascular endothelial cells in the circulating blood (8) Analysis of cytokeratin 18 in the circulating blood and its catabolite (9) Analysis of neovascularization-related proteins in the circulating blood (10) Others

Trial Period
June 2009~May 2011+3 years follow up

Lead Principal Investigator
Masakazu Toi(Graduate School of Kyoto University), Norikazu Masuda(Osaka National Hospital),Takayuki Ueno(Graduate School of Kyoto University)

Target Sample Size
180 (60 per group)

Regimen

Source of Funding
Japan Breast Cancer Research Group(JBCRG)

Conference Presentation

Articles and Publications

UMIN-ID
UMIN000002365

jRCT

Memo

COI Disclosure

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