The Prospects and Problems of Clinical Trials Planned by Japanese Local Study Group; Setouchi Breast Project(Sbp)

The Prospects and Problems of Clinical Trials Planned by Japanese Local Study Group; Setouchi Breast Project(Sbp)

Annals of Oncology 25 (Supplement 5): v75–v109, 2014 doi:10.1093/annonc/mdu436.52 Poster Session (Poster presentations categorized by each organ) P1 ...

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Annals of Oncology 25 (Supplement 5): v75–v109, 2014 doi:10.1093/annonc/mdu436.52

Poster Session (Poster presentations categorized by each organ) P1

24

5

abstracts

Tadahiko Shien1,7, Shozo Ohsumi2,7, Fumikata Hara2,7, Masahiko Ikeda3,7, Shoichiro Ohtani4,7, Naruto Taira1,7, Yutaka Ogasawara5,7, Sachiko Kiyoto2,7, Kinya Matsuoka6,7, Hiroyoshi Doihara1,7 1 Breast and Endocrine Department, Okayama University Hospital 2 Breast Oncology Department, Shikoku Cancer Center 3 Breast and Thyroid Surgery Department, Fukuyama City Hospital 4 Breast Surgery Department, Hiroshima City Hospital 5 Breast and Endocrine Surgery Department, Kagawa Prefectual Central Hospital 6 Breast and Endocrine Surgery Department, Ehime Prefectual Central Hospital 7 Setouchi Breast Project

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THE PROSPECTS AND PROBLEMS OF CLINICAL TRIALS PLANNED BY JAPANESE LOCAL STUDY GROUP; SETOUCHI BREAST PROJECT(SBP)

Background: The strategy of metastatic breast cancer(MBC) treatment has many choices because of the development of new anti-cancer drugs. However the breast cancer patients and medical oncologists who can use new drugs safety and effectively are very few in local areas. We made a NPO corporation Setouchi Breast Project (SBP) and organized clinical trials committee to improvement and standardized of using ant-icancer drugs and activate the study of MBC treatment. Methods: We report the progressing of our committee and trials from 2011 and examine the problems. Results: 37 institutions which are university hospitals, cancer center and private hospitals treating MBC in Chugoku and Shikoku area joined to SBP. We have started 4 phase II trials evaluating the efficacy and safety of combination therapy chemotherapy with molecular drugs, and one cohort trial which investigate the correlation between life style and breast cancer risk. At the begging of PII trial patients were recruited from only big hospital because almost doctors working at small hospital had not used trial drugs. However they could use these drugs after participation to trials by following the trials’ protocol. One of the major problems is lack of individual data management system. We need to collect more resource and funds to develop the valuable of SBP.

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