Clinical Trials

JBCRG-13TR

Translational research for JBCRG-13 ("A phase II study of metronomic paclitaxel + cyclophosphamide + capecitabine (PCX) followed by 5-fluorouracil + epirubicin + cyclophosphamide (FEC) as preoperative chemotherapy for triple negative or low hormone receptors/HER2 negative primary breast cancer")

Status
No Longer Recruiting

Objectives
Identification of a molecular marker to predict the therapeutic effect and a marker for "A phase II study of metronomic paclitaxel + cyclophosphamide + capecitabine (PCX) followed by 5-fluorouracil + epirubicin + cyclophosphamide (FEC) as preoperative chemotherapy for triple negative or low hormone receptors/HER2 negative primary breast cancer."

Subjects
Among the patients who participated in the “A phase II study of metronomic paclitaxel + cyclophosphamide + capecitabine (PCX) followed by 5-fluorouracil + epirubicin + cyclophosphamide (FEC) as preoperative chemotherapy for triple negative or low hormone receptors/HER2 negative primary 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
Jan 2010~Feb 2016(Entry: 2years, Follow up:5years)

Lead Principal Investigator
Takayuki Ueno(Graduate School of Kyoto University)

Target Sample Size
Paitients who agreed to enter JBCRG-13TR

Regimen

Source of Funding
Japan Breast Cancer Research Group(JBCRG)

Conference Presentation

Articles and Publications

UMIN-ID

jRCT

Memo

COI Disclosure

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