Original Article

Randomized phase II study of three doses of oral TAS-108 in postmenopausal patients with metastatic breast cancer

  1. Hideo Inaji1,
  2. Hiroji Iwata2,
  3. Takahiro Nakayama3,
  4. Naohito Yamamoto4,
  5. Yasuyuki Sato5,
  6. Yutaka Tokuda6,
  7. Kenjiro Aogi7,
  8. Shigehira Saji8,
  9. Kenichi Watanabe9,
  10. Tsuyoshi Saito10,
  11. Masayuki Yoshida11,
  12. Nobuaki Sato12,
  13. Toshiaki Saeki13,
  14. Yuichi Takatsuka14,
  15. Masaru Kuranami15,
  16. Hiroko Yamashita16,
  17. Atsushi Kikuchi17,
  18. Toshio Tabei18,
  19. Tadashi Ikeda19,
  20. Shinzaburo Noguchi20,*

Article first published online: 16 JUL 2012

DOI: 10.1111/j.1349-7006.2012.02354.x

Issue

Cancer Science

Cancer Science

Volume 103, Issue 9, pages 1708–1713, September 2012

Additional Information

How to Cite

(Cancer Sci, 2012; 103: 1708–1713)

Author Information

  1. 1

    Department of Breast and Endocrine Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan

  2. 2

    Department of Breast Oncology, Aichi Cancer Center, Nagoya, Japan

  3. 3

    Department of Breast and Endocrine Surgery, Sakai Municipal Hospital, Sakai, Japan

  4. 4

    Division of Breast Surgery, Chiba Cancer Center, Chiba, Japan

  5. 5

    Department of Surgery, Nagoya Medical Center, Nagoya, Japan

  6. 6

    Department of Surgery, Tokai University School of Medicine, Isehara, Japan

  7. 7

    Department of Breast Oncology, Shikoku Cancer Center, Matsuyama, Japan

  8. 8

    Department of Surgery and Breast Oncology, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan

  9. 9

    Department of Breast Surgery, Hokkaido Cancer Center, Sapporo, Japan

  10. 10

    Department of Breast Surgery, Saitama Red Cross Hospital, Saitama, Japan

  11. 11

    Department of Breast Surgery, Seirei Hamamatsu General Hospital, Hamamatsu, Japan

  12. 12

    Department of Surgery, Niigata Cancer Center Hospital, Niigata, Japan

  13. 13

    Department of Breast Oncology, Saitama International Medical Center, Saitama Medical University, Hidaka, Japan

  14. 14

    Department of Breast Surgery, Kansai Rosai Hospital, Amagasaki, Japan

  15. 15

    Department of Surgery, Kitasato University School of Medicine, Sagamihara, Japan

  16. 16

    Department of Oncology, Immunology and Surgery, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan

  17. 17

    Department of Surgery, Yamagata Prefectural Central Hospital, Yamagata, Japan

  18. 18

    Division of Breast Oncology, Saitama Cancer Center, Ina, Japan

  19. 19

    Department of Surgery, Teikyo University School of Medicine, Tokyo, Japan

  20. 20

    Department of Breast and Endocrine Surgery, Graduate School of Medicine, Osaka University, Suita, Japan

* To whom correspondence should be addressed.
E-mail: noguchi@onsurg.med.osaka-u.ac.jp

Publication History

  1. Issue published online: 3 SEP 2012
  2. Article first published online: 16 JUL 2012
  3. Accepted manuscript online: 7 JUN 2012 12:00AM EST
  4. Manuscript Accepted: 25 MAY 2012
  5. Manuscript Revised: 24 MAY 2012
  6. Manuscript Received: 4 MAR 2012

Funded by

  • Taiho Pharmaceuticals

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This randomized phase II study was intended to identify the optimal dose of TAS-108, a novel steroidal antiestrogen, for the treatment of breast cancer in postmenopausal Japanese women. The potential clinical effects of TAS-108 on the uterus, bone, serum lipids, and hormones were also investigated. Postmenopausal women with hormone receptor-positive metastatic breast cancer who had previously received one or two endocrine therapies were randomly assigned to one of the three possible dose levels of TAS-108 (40, 80 or 120 mg/day). Oral TAS-108 was given daily, and the efficacy and safety of the three doses were evaluated. A total of 97 patients (33, 32, and 32 in the 40-, 80-, and 120-mg groups, respectively) were treated with TAS-108. The clinical benefit rate was 30.3% for the 40-mg, 25.0% for the 80-mg, and 25.0% for the 120-mg group. The 40-mg group achieved the prespecified target threshold. TAS-108 at all dose levels was well tolerated and appeared to have no harmful effects in terms of the variables examined in this study. We conclude that the optimal dose of TAS-108 among the three doses is 40 mg, once daily, for further studies. JAPIC Clinical Trials Information number: Japic CTI – 121754.

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