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JBCRG-07TR
Translational research for JBCRG-07 ("Phase II study of combination therapy of preoperative Letrozole and low-dose Metronomic Cyclophosphamide for postmenopausal / hormone receptor positive breast cancer")
- Status
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No Longer Recruiting
- Objectives
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Identification of a molecular marker to predict the therapeutic effect and a marker for therapeutic monitoring of preoperative LC whereby aromatase inhibitors, Letrozole and Metronomic Cyclophosphamide are administered in postmenopausal women that have hormone receptor-positive operable primary breast cancer {T2-4N0-1M0}
- Subjects
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Among the patients who participated in the “Phase II study of combination therapy of preoperative Letrozole and low-dose Metronomic Cyclophosphamide for postmenopausal / hormone receptor 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
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(1) Expression of molecules associated with cell proliferation and cell death (2) Expression of molecules involved in cell infiltration (3) Expression of molecules associated with hormone receptors/membrane receptors (4) Expression of angiogenic molecules (5) Tumor vessel density (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) Detection of the expression profile using the serum protein analysis system (11) Others
- Trial Period
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October 2007 - September 2014 (Registration: 2 years, Follow-up study: 5 years)
- Lead Principal Investigator
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Norikazu Masuda (Department of Surgery, Osaka National Hospital)
- Target Sample Size
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40
- Regimen
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- Source of Funding
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Japan Breast Cancer Research Group(JBCRG)
- Conference Presentation
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- Articles and Publications
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Differential Involvement of Autophagy and Apoptosis in Response to Chemoendocrine and Endocrine Therapy in Breast Cancer: JBCRG-07TR
- UMIN-ID
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- jRCT
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- Memo
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- COI Disclosure
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