Department of Surgery

Breast and Endocrine Surgery

Personalized medicine for breast cancer: development and practical application of molecular diagnostic methods
    • Development of a molecular based prediction model for prognosis and drug susceptibility
    • Development of a highly sensitive detection method for circulating tumor DNA by next generation sequencing
    • Improving the detection accuracy of sentinel lymph node metastasis by OSNA
    • Validation of novel molecular diagnostic methods in clinical trials
    • Identification of genes related to drug resistance
Breast and Endocrine Surgery
The Department of Breast and Endocrine Surgery originates from the Deptartment of Surgery, Research Institute for Microbial Diseases, Osaka University. Professor Shinzaburo Noguchi has been head of the department since 1998.

Towards personalized medicine: development of highly accurate, state-of-the-art molecular diagnostic methods for prognosis and drug susceptibility in breast cancer

The laboratory conducts clinical work and basic research on breast cancer, which is the most prevalent cancer in women with over 90,000 new cases reported annually. Thus, it is essential to develop a molecular diagnostic method that can accurately diagnose specific molecular patterns of breast cancer in order to provide the best medical care. To this end, the lab is working on the development of novel molecular diagnostic methods.

In order to administer an appropriate adjuvant chemotherapy based on the risk of recurrence in individual breast cancer patients, it is critical to develop a diagnostic method for accurate prognosis. The lab has developed and commercialized a 95-gene classifier (95-GC) for prognosis prediction for breast cancer (Curebest 95 GC Breast®, Sysmex Corporation), which analyzes the expression profiles of 95 genes found in breast cancer tissue [1, 2]. Using this method, it is possible to distinguish between high- and low-risk recurrence groups. The prognostic accuracy can be further improved by combining Curebest 95 GC with Oncotype DX.


Because a standardized and accurate method to predict the effectiveness of chemotherapy on breast cancer does not exist, inappropriate chemotherapy has been frequently prescribed. Therefore, the lab developed a chemo-sensitivity prediction method (IRSN 23, Japanese Patent Application No. 14182820.2) based on the analysis of 23 immune related gene expression profiles in breast cancer tissue [3]. Using this method, it is possible to diagnose preoperative chemotherapy failure with high precision. The lab has also developed a high-sensitivity detection method for circulating tumor DNA (ctDNA) to monitor recurrence, One-Step Methylation Specific PCR [4, 5]. In addition to developing more accurate and sensitive ctDNA detection methods using next generation sequencing, the lab is currently working on elucidating mechanisms of hormone and anti-HER2 therapy resistance and improving the OSNA (one-step nucleic acid) method for detection of lymph node metastasis.

The lab is currently planning or carrying out clinical trials to evaluate the utility of these novel molecular diagnostic methods. Finally, the lab strives for excellence in both clinical and research of breast cancer.


1.Naoi et al. Breast Cancer Res Treat 128: 633-641, 2011.
2.Oshima et al. Cancer Lett 307: 149-157, 2013.
3.Sota et al. Ann Oncol 25: 100-106, 2014.
4.Yamamoto et al. Breast Cancer Res Treat 132: 165-173, 2012.
5.Takahashi et al. Clinical Breast Cancer 17(1):61-69, 2016.