Post-marketing Surveillance for the Clinical Safety and Effectiveness of Eribulin Mesylate in Patients With Inoperable or Recurrent Breast Cancer (Study HAL01S)

Post-marketing Surveillance for the Clinical Safety and Effectiveness of Eribulin Mesylate in Patients With Inoperable or Recurrent Breast Cancer

To investigate of the clinical safety and effectiveness of eribulin mesylate in patients with inoperable or recurrent breast cancer

Study Overview

• Status: Completed
• Conditions: Inoperable or Recurrent Breast Cancer
• Intervention / Treatment: Drug: Eribulin Mesylate

• Study Type: Observational
• Enrollment (Actual): 963

Contacts and Locations

Study Locations

• Japan
  • Aomori, Japan
  • Chiba, Japan
  • Fukui, Japan
  • Fukuoka, Japan
  • Fukushima, Japan
  • Gifu, Japan
  • Hiroshima, Japan
  • Kagoshima, Japan
  • Kochi, Japan
  • Kumamoto, Japan
  • Kyoto, Japan
  • Miyazaki, Japan
  • Nagano, Japan
  • Nagasaki, Japan
  • Niigata, Japan
  • Oita, Japan
  • Okayama, Japan
  • Okinawa, Japan
  • Osaka, Japan
  • Saga, Japan
  • Saitama, Japan
  • Shizuoka, Japan
  • Tokushima, Japan
  • Tottori, Japan
  • Toyama, Japan
  • Aichi
    • Anjo, Aichi, Japan
    • Inazawa, Aichi, Japan
    • Kariya, Aichi, Japan
    • Komaki, Aichi, Japan
    • Nagakute, Aichi, Japan
    • Nagoya, Aichi, Japan
    • Okazaki, Aichi, Japan
    • Seto, Aichi, Japan
    • Tahara, Aichi, Japan
    • Toyohashi, Aichi, Japan
  • Akita
    • Daisen, Akita, Japan
    • Yokote, Akita, Japan
  • Aomori
    • Goshogawara, Aomori, Japan
    • Hirosaki, Aomori, Japan
    • Kuroishi, Aomori, Japan
    • Misawa, Aomori, Japan
    • Mutsu, Aomori, Japan
  • Chiba
    • Asahi, Chiba, Japan
    • Funabashi, Chiba, Japan
    • Ichihara, Chiba, Japan
    • Ichikawa, Chiba, Japan
    • Kashiwa, Chiba, Japan
    • Kimitsu, Chiba, Japan
    • Matsudo, Chiba, Japan
    • Sakura, Chiba, Japan
  • Ehime
    • Matsuyama, Ehime, Japan
    • Niihama, Ehime, Japan
  • Fukuoka
    • Iizuka, Fukuoka, Japan
    • Kasuga, Fukuoka, Japan
    • Kitakyushu, Fukuoka, Japan
    • Kurume, Fukuoka, Japan
    • Omuta, Fukuoka, Japan
    • Yame, Fukuoka, Japan
    • Yanagawa, Fukuoka, Japan
  • Fukushima
    • Minamisoma, Fukushima, Japan
    • Nihonmatsu, Fukushima, Japan
  • Gifu
    • Ena, Gifu, Japan
    • Hashima, Gifu, Japan
    • Minokamo, Gifu, Japan
    • Ogaki, Gifu, Japan
    • Seki, Gifu, Japan
    • Tajimi, Gifu, Japan
    • Takayama, Gifu, Japan
  • Gumma
    • Maebashi, Gumma, Japan
    • Ota, Gumma, Japan
    • Shibukawa, Gumma, Japan
    • Takasaki, Gumma, Japan
  • Hiroshima
    • Aki, Hiroshima, Japan
    • Fukuyama, Hiroshima, Japan
    • Hatsukaichi, Hiroshima, Japan
    • Higashihiroshima, Hiroshima, Japan
    • Kure, Hiroshima, Japan
    • Mihara, Hiroshima, Japan
    • Onomichi, Hiroshima, Japan
  • Hokkaido
    • Abashiri, Hokkaido, Japan
    • Asahikawa, Hokkaido, Japan
    • Date, Hokkaido, Japan
    • Eniwa, Hokkaido, Japan
    • Hakodate, Hokkaido, Japan
    • Kitahiroshima, Hokkaido, Japan
    • Kitami, Hokkaido, Japan
    • Kushiro, Hokkaido, Japan
    • Muroran, Hokkaido, Japan
    • Obihiro, Hokkaido, Japan
    • Sapporo, Hokkaido, Japan
    • Shibetsu, Hokkaido, Japan
  • Hyogo
    • Akashi, Hyogo, Japan
    • Amagasaki, Hyogo, Japan
    • Himeji, Hyogo, Japan
    • Kobe, Hyogo, Japan
    • Nishinomiya, Hyogo, Japan
    • Toyooka, Hyogo, Japan
  • Ibaraki
    • Higashiibaraki, Ibaraki, Japan
    • Inashiki, Ibaraki, Japan
    • Kamisu, Ibaraki, Japan
    • Kasama, Ibaraki, Japan
    • Koga, Ibaraki, Japan
    • Moriya, Ibaraki, Japan
    • Tsukuba, Ibaraki, Japan
    • Ushiku, Ibaraki, Japan
  • Ishikawa
    • Kahoku, Ishikawa, Japan
    • Kanazawa, Ishikawa, Japan
    • Komatsu, Ishikawa, Japan
    • Nomi, Ishikawa, Japan
  • Kagawa
    • Takamatsu, Kagawa, Japan
  • Kagoshima
    • Akune, Kagoshima, Japan
  • Kanagawa
    • Chigasaki, Kanagawa, Japan
    • Ebina, Kanagawa, Japan
    • Isehara, Kanagawa, Japan
    • Kamakura, Kanagawa, Japan
    • Kawasaki, Kanagawa, Japan
    • Odawara, Kanagawa, Japan
    • Sagamihara, Kanagawa, Japan
    • Yokohama, Kanagawa, Japan
    • Yokosuka, Kanagawa, Japan
  • Kumamoto
    • Arao, Kumamoto, Japan
    • Tamana, Kumamoto, Japan
  • Kyoto
    • Nagaokakyo, Kyoto, Japan
  • Mie
    • Ise, Mie, Japan
    • Matsusaka, Mie, Japan
    • Suzuka, Mie, Japan
    • Tsu, Mie, Japan
    • Yokkaichi, Mie, Japan
  • Miyagi
    • Osaki, Miyagi, Japan
    • Sendai, Miyagi, Japan
    • Shibata, Miyagi, Japan
  • Nagano
    • Iida, Nagano, Japan
    • Komagane, Nagano, Japan
    • Matsumoto, Nagano, Japan
    • Saku, Nagano, Japan
    • Suwa, Nagano, Japan
  • Nagasaki
    • Shimabara, Nagasaki, Japan
  • Nara
    • Ikoma, Nara, Japan
    • Kashihara, Nara, Japan
    • Yamatotakada, Nara, Japan
  • Niigata
    • Minamiuonuma, Niigata, Japan
  • Okayama
    • Kurashiki, Okayama, Japan
    • Maniwa, Okayama, Japan
    • Tamano, Okayama, Japan
    • Wake, Okayama, Japan
  • Okinawa
    • Naha, Okinawa, Japan
    • Nakagami, Okinawa, Japan
    • Shimajiri, Okinawa, Japan
    • Tomigusuku, Okinawa, Japan
    • Urasoe, Okinawa, Japan
  • Osaka
    • Higashiosaka, Osaka, Japan
    • Hirakata, Osaka, Japan
    • Ibaraki, Osaka, Japan
    • Izumiotsu, Osaka, Japan
    • Katano, Osaka, Japan
    • Neyagawa, Osaka, Japan
    • Osakasayama, Osaka, Japan
    • Takatsuki, Osaka, Japan
    • Yao, Osaka, Japan
  • Saga
    • Karatsu, Saga, Japan
  • Saitama
    • Fujimino, Saitama, Japan
    • Fukaya, Saitama, Japan
    • Hidaka, Saitama, Japan
    • Hiki, Saitama, Japan
    • Kawaguchi, Saitama, Japan
    • Kumagaya, Saitama, Japan
    • Toda, Saitama, Japan
    • Tokorozawa, Saitama, Japan
  • Shiga
    • Kusatsu, Shiga, Japan
    • Otsu, Shiga, Japan
    • Ritto, Shiga, Japan
  • Shimane
    • Izumo, Shimane, Japan
    • Matsue, Shimane, Japan
  • Shizuoka
    • Fujieda, Shizuoka, Japan
    • Fujinomiya, Shizuoka, Japan
    • Gotemba, Shizuoka, Japan
    • Hamamatsu, Shizuoka, Japan
    • Izunokuni, Shizuoka, Japan
    • Numazu, Shizuoka, Japan
    • Shimada, Shizuoka, Japan
    • Sunto, Shizuoka, Japan
  • Tochigi
    • Ashikaga, Tochigi, Japan
    • Oyama, Tochigi, Japan
  • Tokyo
    • Adachi, Tokyo, Japan
    • Akishima, Tokyo, Japan
    • Bunkyo, Tokyo, Japan
    • Chiyoda, Tokyo, Japan
    • Chuo, Tokyo, Japan
    • Fuchu, Tokyo, Japan
    • Fussa, Tokyo, Japan
    • Hachioji, Tokyo, Japan
    • Hino, Tokyo, Japan
    • Itabashi, Tokyo, Japan
    • Katsushika, Tokyo, Japan
    • Kita, Tokyo, Japan
    • Koto, Tokyo, Japan
    • Machida, Tokyo, Japan
    • Meguro, Tokyo, Japan
    • Minato, Tokyo, Japan
    • Mitaka, Tokyo, Japan
    • Nerima, Tokyo, Japan
    • Ota, Tokyo, Japan
    • Setagaya, Tokyo, Japan
    • Shibuya, Tokyo, Japan
    • Shinagawa, Tokyo, Japan
    • Shinjuku, Tokyo, Japan
    • Tachikawa, Tokyo, Japan
    • Taito, Tokyo, Japan
    • Tama, Tokyo, Japan
  • Tottori
    • Kurayoshi, Tottori, Japan
    • Yonago, Tottori, Japan
  • Toyama
    • Nakaniikawa, Toyama, Japan
    • Namerikawa, Toyama, Japan
    • Oyabe, Toyama, Japan
    • Takaoka, Toyama, Japan
  • Yamagata
    • Tsuruoka, Yamagata, Japan
  • Yamaguchi
    • Hagi, Yamaguchi, Japan
    • Iwakuni, Yamaguchi, Japan
    • Nagato, Yamaguchi, Japan
    • Shimonoseki, Yamaguchi, Japan
  • Yamanashi
    • Chuo, Yamanashi, Japan
    • Kofu, Yamanashi, Japan
    • Minamikoma, Yamanashi, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Hospitals and clinics in Japan

Description

Inclusion criteria :

• Inoperable breast cancer
• Recurrent breast cancer

Exclusion criteria :

• Corresponding to contraindication of eribulin mesylate
• Not applicable to indications of eribulin mesylate
• Not applicable to aggravation or recurrence of breast cancer in patients who have previously been treated with anthracycline and/or taxane antitumor drugs

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Eribulin Mesylate

Drug: Eribulin Mesylate; The usual adult dose of eribulin mesylate is 1.4 mg/m^2 (body surface area) administered intravenously over 2 to 5 minutes, once daily once a week. Treatment shall be continued for 2 consecutive weeks followed by a third week of drug cessation. With each cycle lasting 3 weeks, the treatment shall be repeated. The dose may be reduced, depending on the condition of the individual patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness Diagnosed by Imaging	Effectiveness diagnosed by imaging, is based on Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. Defined as: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to less than10 mm.; Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.; Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.; Not Evaluable (NE).	1 year

Collaborators and Investigators

• Sponsor: Eisai Co., Ltd.
• Investigators: Study Director: Toshiyuki Matsuoka, Drug Fostering and Evolution Cordination Department, Eisai Co., Ltd.

Publications and helpful links

General Publications

• Watanabe J, Ito Y, Ohsumi S, Mizutani M, Tashiro H, Sakurai K, Takahashi M, Saito T, Tsurutani J, Mukai H, Yoshinami T, Takao S, Yamamoto Y, Matsuoka T, Iwase H, Iwata H, Nakamura S, Saeki T. Safety and effectiveness of eribulin in Japanese patients with locally advanced or metastatic breast cancer: a post-marketing observational study. Invest New Drugs. 2017 Dec;35(6):791-799. doi: 10.1007/s10637-017-0486-4. Epub 2017 Jun 29.

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2011
• Primary Completion (Actual): December 26, 2012
• Study Completion (Actual): November 27, 2013

Study Registration Dates

• First Submitted: September 29, 2011
• First Submitted That Met QC Criteria: October 31, 2011
• First Posted (Estimated): November 2, 2011

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 21, 2023
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Eribulin Mesylate; inoperable or recurrent breast cancer
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Neoplasms by Site; Disease Attributes; Breast Diseases; Breast Neoplasms; Recurrence
• Other Study ID Numbers: HAL01S

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No