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Department of Breast and Medical Oncology

Tetsuo Akimoto, Hirofumi Mukai, Nobuaki Matsubara, Yoichi Naito, Masaoki Sasaki, Ako Hosono, Mai Onomura, Yoko Yamada, Hiroaki Izumi, Tetsuya Urasaki, Yujiro Ueda, Takaaki Yokoyama


Patients with different types of cancer, including those with breast and genitourinary tract cancers, are treated with standard chemotherapy and/or managed in clinical trials in daily medical practice at the Department of Breast/Medical Oncology. Gynecological malignancies and soft tissue sarcomas are also treated with chemotherapy. Another major target of the Department is cancer of unknown primary origin. The clinical and research activities of the Department primarily focus on the following fields: Standard chemotherapeutic treatment in medical practice, disease-oriented clinical trials, developmental therapeutics of new anticancer agents sponsored by pharmaceutical companies and development of combination chemotherapy involving newly developed drugs or new combinations of currently available drugs.

Routine activities

The major and specific target disease of the Department comprised breast cancer. Eligible patients were invited to participate in large phase II/III studies. The Department also treated cancers of the genitourinary tract, cancer of unknown primary origin, soft tissue sarcomas and gynecological cancers including uterine and ovarian cancers. For patients with diseases treated with established standard chemotherapeutic regimens, standard chemotherapy was administered in routine medical practice. Patients in whom standard chemotherapy had failed and those with cancers for which standard chemotherapy was unavailable were invited to participate in clinical studies on experimental drugs and regimens. In 2015, 624 patients with different types of cancer visited the Department for consultation. Approximately 400 patients per month received routine chemotherapy as an outpatient service by the Department. The overall inpatient care system of the held on every morning. A weekly educational meeting is conducted on Thursday morning. Moreover, a biweekly joint conference is held on Wednesday evenings and on Monday evenings with breast surgeons and with urologists, respectively. Morning journal clubs also meet on Mondays and Fridays at the Department in collaboration with the Division of hematology.

Research activities

Phase I studies of the following anticancer agents were conducted: K912 (epirubicin-incorporating micellar nanoparticle formulation) for patients with solid tumors for which standard chemotherapy was unavailable, and NK105 (paclitaxel-incorporating micellar nanoparticle formulation) for patients with advanced or metastatic cancer. Phase I/II studies of new anticancer agents for specific disease targets are conducted in collaboration with pharmaceutical companies.

In addition, many phase III studies are being conducted as follows: Randomized, optimal dose finding, Phase II Study of triweekly Abraxane in patients with metastatic breast cancer; Evaluation of Oral Care to Prevent Oral Mucositis in Estrogen Receptor Positive Metastatic Breast Cancer Patients Treated with Everolimus. (Oral Care-BC): Randomized Controlled Phase III Trial; A randomized controlled trial comparing primary tumor resection plus systemic therapy with systemic therapy alone in metastatic breast cancer; Intensive vs. standard post-operative surveillance in high risk breast cancer patients; Adjuvant Chemotherapy Trial of S-1 for breast cancer with ER-positive and HER2-negative; a randomized double-blind placebo-controlled trial of neratinib (an erbB1/2/4 inhibitor) after trastuzumab in women with early-stage HER-2 overexpressed /amplified breast cancer; a randomized multicenter, double-blind, placebo-controlled comparison of chemotherapy plus trastuzumab plus placebo versus chemotherapy plus trastuzumab plus pertuzumab as adjuvant therapy in patients with operable HER2-positive primary breast cancer (APHINITY: Adjuvant Pertuzumab and Herceptin IN Initial Therapy); a randomized phase III study on NK105 versus paclitaxel in patients with recurrent or metastatic breast cancer; and a randomized phase III study on lapatinib, trastuzumab, and both lapatinib and trastuzumab, combined with aromatase inhibitor in patients with HER-2 overexpressed breast cancer who received neo-/adjuvant therapy with trastuzumab and endocrine therapy.

Table 1. Number of new patients

List of papers published in 2015


  1. Hayashi N, Niikura N, Masuda N, Takashima S, Nakamura R, Watanabe K, Kanbayashi C, Ishida M, Hozumi Y, Tsuneizumi M, Kondo N, Naito Y, Honda Y, Matsui A, Fujisawa T, Oshitanai R, Yasojima H, Yamauchi H, Saji S, Iwata H. Prognostic factors of HER2-positive breast cancer patients who develop brain metastasis: a multicenter retrospective analysis. Breast Cancer Res Treat, 149:277-284, 2015
  2. Mukai H, Saeki T, Shimada K, Naito Y, Matsubara N, Nakanishi T, Obaishi H, Namiki M, Sasaki Y. Phase 1 combination study of eribulin mesylate with trastuzumab for advanced or recurrent human epidermal growth factor receptor 2 positive breast cancer. Invest New Drugs, 33:119-127, 2015
  3. Taira N, Arai M, Ikeda M, Iwasaki M, Okamura H, Takamatsu K, Yamamoto S, Ohsumi S, Mukai H, Japanese Breast Cancer Society. The Japanese Breast Cancer Society clinical practice guideline for epidemiology and prevention of breast cancer. Breast Cancer, 22:16-27, 2015
  4. Mukai H, Masuda N, Ishiguro H, Mitsuma A, Shibata T, Yamamura J, Toi M, Watabe A, Sarashina A, Uttenreuther-Fischer M, Ando Y. Phase I trial of afatinib plus vinorelbine in Japanese patients with advanced solid tumors, including breast cancer. Cancer Chemother Pharmacol, 76:739-750, 2015
  5. Nozawa M, Mukai H, Takahashi S, Uemura H, Kosaka T, Onozawa Y, Miyazaki J, Suzuki K, Okihara K, Arai Y, Kamba T, Kato M, Nakai Y, Furuse H, Kume H, Ide H, Kitamura H, Yokomizo A, Kimura T, Tomita Y, Ohno K, Kakehi Y. Japanese phase I study of cabazitaxel in metastatic castration-resistant prostate cancer. Int J Clin Oncol, 20:1026-1034, 2015
  6. Gelmon KA, Boyle FM, Kaufman B, Huntsman DG, Manikhas A, Di Leo A, Martin M, Schwartzberg LS, Lemieux J, Aparicio S, Shepherd LE, Dent S, Ellard SL, Tonkin K, Pritchard KI, Whelan TJ, Nomikos D, Nusch A, Coleman RE, Mukai H, Tjulandin S, Khasanov R, Rizel S, Connor AP, Santillana SL, Chapman JA, Parulekar WR. Lapatinib or Trastuzumab Plus Taxane Therapy for Human Epidermal Growth Factor Receptor 2-Positive Advanced Breast Cancer: Final Results of NCIC CTG MA.31. J Clin Oncol, 33:1574-1583, 2015
  7. Mukai H, Aihara T, Yamamoto Y, Takahashi M, Toyama T, Sagara Y, Yamaguchi H, Akabane H, Tsurutani J, Hara F, Fujisawa T, Yamamoto N, Ohsumi S, Japanese Breast Cancer Society. The Japanese Breast Cancer Society Clinical Practice Guideline for systemic treatment of breast cancer. Breast Cancer, 22:5-15, 2015
  8. Tozaki M, Isomoto I, Kojima Y, Kubota K, Kuroki Y, Ohnuki K, Ohsumi S, Mukai H, Japanese Breast Cancer Society. The Japanese Breast Cancer Society Clinical Practice Guideline for screening and imaging diagnosis of breast cancer. Breast Cancer, 22:28-36, 2015
  9. Mukai H, Noguchi S, Akiyama F, Inaji H, Iwase H, Horiguchi J, Kurebayashi J, Hirata K, Toi M, Kurosumi M, Kohno N, Nishimura R, Nakamura S, Imoto S, Iwase T, Endo T, Saeki T, Ogawa Y, Ito Y, Tokuda Y, Ikeda T. 2013 clinical practice guidelines (The Japanese Breast Cancer Society): history, policy and mission. Breast Cancer, 22:1-4, 2015
  10. Horii R, Honma N, Ogiya A, Kozuka Y, Fukuda T, Yoshida M, Ohsumi S, Mukai H, Japanese Breast Cancer Society. The Japanese Breast Cancer Society Clinical Practice Guideline for pathological diagnosis of breast cancer. Breast Cancer, 22:59-65, 2015
  11. Sekiguchi K, Ogawa Y, Sanuki N, Arahira S, Ogo E, Yoshimura M, Yamauchi C, Oguchi M, Ohsumi S, Mukai H, Japanese Breast Cancer Society. The Japanese Breast Cancer Society clinical practice guideline for radiotherapy of breast cancer. Breast Cancer, 22:49-58, 2015
  12. Ueda Y, Matsubara N, Takizawa I, Nishiyama T, Tabata K, Satoh T, Kamiya N, Suzuki H, Kawahara T, Uemura H. A multicenter retrospective analysis of sequential treatment of abiraterone acetate followed by docetaxel in Japanese patients with metastatic castration-resistant prostate cancer. Jpn J Clin Oncol, 45:774-779, 2015
  13. Komoike Y, Inokuchi M, Itoh T, Kitamura K, Kutomi G, Sakai T, Jinno H, Wada N, Ohsumi S, Mukai H, Japanese Breast Cancer Society. Japan Breast Cancer Society clinical practice guideline for surgical treatment of breast cancer. Breast Cancer, 22:37-48, 2015
  14. Iwata H, Fujii H, Masuda N, Mukai H, Nishimura Y, Katsura K, Ellis CE, Gagnon RC, Nakamura S. Efficacy, safety, pharmacokinetics and biomarker findings in patients with HER2-positive advanced or metastatic breast cancer treated with lapatinib in combination with capecitabine: results from 51 Japanese patients treated in a clinical study. Breast Cancer, 22:192-200, 2015
  15. Yamaguchi T, Mukai H, Yamashita S, Fujii S, Ushijima T. Comprehensive DNA methylation and extensive mutation analyses of HER2-positive breast cancer. Oncology, 88:377-384, 2015