Post-marketing Surveillance for the Clinical Safety and Effectiveness of Eribulin Mesylate in Patients With Inoperable or Recurrent Breast Cancer (Study HAL01S)
NCT ID: NCT01463891
Last Updated: 2023-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
963 participants
OBSERVATIONAL
2011-07-19
2013-11-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Eribulin Mesylate
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Recurrent breast cancer
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Eisai Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Toshiyuki Matsuoka
Role: STUDY_DIRECTOR
Drug Fostering and Evolution Cordination Department, Eisai Co., Ltd.
Locations
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Anjo, Aichi-ken, Japan
Inazawa, Aichi-ken, Japan
Kariya, Aichi-ken, Japan
Komaki, Aichi-ken, Japan
Nagakute, Aichi-ken, Japan
Nagoya, Aichi-ken, Japan
Okazaki, Aichi-ken, Japan
Seto, Aichi-ken, Japan
Tahara, Aichi-ken, Japan
Toyohashi, Aichi-ken, Japan
Daisen, Akita, Japan
Yokote, Akita, Japan
Goshogawara, Aomori, Japan
Hirosaki, Aomori, Japan
Kuroishi, Aomori, Japan
Misawa, Aomori, Japan
Mutsu, Aomori, Japan
Asahi, Chiba, Japan
Funabashi, Chiba, Japan
Ichihara, Chiba, Japan
Ichikawa, Chiba, Japan
Kashiwa, Chiba, Japan
Kimitsu, Chiba, Japan
Matsudo, Chiba, Japan
Sakura, Chiba, Japan
Matsuyama, Ehime, Japan
Niihama, Ehime, Japan
Iizuka, Fukuoka, Japan
Kasuga, Fukuoka, Japan
Kitakyushu, Fukuoka, Japan
Kurume, Fukuoka, Japan
Omuta, Fukuoka, Japan
Yame, Fukuoka, Japan
Yanagawa, Fukuoka, Japan
Minamisoma, Fukushima, Japan
Nihommatsu, Fukushima, Japan
Ena, Gifu, Japan
Hashima, Gifu, Japan
Minokamo, Gifu, Japan
Ōgaki, Gifu, Japan
Sekimachi, Gifu, Japan
Tajimi, Gifu, Japan
Takayama, Gifu, Japan
Maebashi, Gunma, Japan
Ōta, Gunma, Japan
Shibukawa, Gunma, Japan
Takasaki, Gunma, Japan
Aki, Hiroshima, Japan
Fukuyama, Hiroshima, Japan
Hatsukaichi, Hiroshima, Japan
Higashihiroshima, Hiroshima, Japan
Kure, Hiroshima, Japan
Mihara, Hiroshima, Japan
Onomichi, Hiroshima, Japan
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
Akashi, Hyōgo, Japan
Amagasaki, Hyōgo, Japan
Himeji, Hyōgo, Japan
Kobe, Hyōgo, Japan
Nishinomiya, Hyōgo, Japan
Toyooka, Hyōgo, Japan
Higashiibaraki, Ibaraki, Japan
Inashiki, Ibaraki, Japan
Kamisu, Ibaraki, Japan
Kasama, Ibaraki, Japan
Koga, Ibaraki, Japan
Moriya, Ibaraki, Japan
Tsukuba, Ibaraki, Japan
Ushiku, Ibaraki, Japan
Kahoku, Ishikawa-ken, Japan
Kanazawa, Ishikawa-ken, Japan
Komatsu, Ishikawa-ken, Japan
Nomi, Ishikawa-ken, Japan
Takamatsu, Kagawa-ken, Japan
Akune, Kagoshima-ken, Japan
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
Arao, Kumamoto, Japan
Tamana, Kumamoto, Japan
Kōtari, Kyoto, Japan
Ise, Mie-ken, Japan
Matsusaka, Mie-ken, Japan
Suzuka, Mie-ken, Japan
Tsu, Mie-ken, Japan
Yokkaichi, Mie-ken, Japan
Murata, Miyagi, Japan
Ōsaki, Miyagi, Japan
Sendai, Miyagi, Japan
Iida, Nagano, Japan
Komagane, Nagano, Japan
Matsumoto, Nagano, Japan
Saku, Nagano, Japan
Suwa, Nagano, Japan
Shimabara, Nagasaki, Japan
Ikoma, Nara, Japan
Kashihara, Nara, Japan
Yamatotakada, Nara, Japan
Minamiuonuma, Niigata, Japan
Kurashiki, Okayama-ken, Japan
Maniwa, Okayama-ken, Japan
Tamano, Okayama-ken, Japan
Wake, Okayama-ken, Japan
Naha, Okinawa, Japan
Nakagami, Okinawa, Japan
Shimajiri, Okinawa, Japan
Tomigusuku, Okinawa, Japan
Urasoe, Okinawa, Japan
Higashiosaka, Osaka, Japan
Hirakata, Osaka, Japan
Ibaraki, Osaka, Japan
Izumiōtsu, Osaka, Japan
Katano, Osaka, Japan
Neyagawa, Osaka, Japan
Sayama, Osaka, Japan
Takatsuki, Osaka, Japan
Yao, Osaka, Japan
Karatsu, Saga-ken, Japan
Fujimino, Saitama, Japan
Fukaya, Saitama, Japan
Hidaka, Saitama, Japan
Hiki, Saitama, Japan
Kawaguchi, Saitama, Japan
Kumagaya, Saitama, Japan
Toda, Saitama, Japan
Tokorozawa, Saitama, Japan
Kusatsu, Shiga, Japan
Ōtsu, Shiga, Japan
Rittō, Shiga, Japan
Izumo, Shimane, Japan
Matsue, Shimane, Japan
Fujieda, Shizuoka, Japan
Fujinomiya, Shizuoka, Japan
Gotemba, Shizuoka, Japan
Hamamatsu, Shizuoka, Japan
Izunokuni, Shizuoka, Japan
Numazu, Shizuoka, Japan
Shimada, Shizuoka, Japan
Sunto, Shizuoka, Japan
Ashikaga, Tochigi, Japan
Oyama, Tochigi, Japan
Adachi City, Tokyo, Japan
Akishima, Tokyo, Japan
Bunkyo, Tokyo, Japan
Chiyoda City, Tokyo, Japan
Chūō, Tokyo, Japan
Fuchū, Tokyo, Japan
Fussa, Tokyo, Japan
Hachiōji, Tokyo, Japan
Hino, Tokyo, Japan
Katsushika-ku, Tokyo, Japan
Kita-ku, Tokyo, Japan
Koto, Tokyo, Japan
Machida, Tokyo, Japan
Meguro City, Tokyo, Japan
Minato, Tokyo, Japan
Mitaka, Tokyo, Japan
Nerima City, Tokyo, Japan
Ōta-ku, Tokyo, Japan
Setagaya City, Tokyo, Japan
Shibuya City, Tokyo, Japan
Shinagawa, Tokyo, Japan
Shinjuku, Tokyo, Japan
tabashi City, Tokyo, Japan
Tachikawa, Tokyo, Japan
Taitō City, Tokyo, Japan
Tama, Tokyo, Japan
Kurayoshi, Tottori, Japan
Yonago, Tottori, Japan
Nakaniikawa, Toyama, Japan
Namerikawa, Toyama, Japan
Oyabe, Toyama, Japan
Takaoka, Toyama, Japan
Tsuruoka, Yamagata, Japan
Hagi, Yamaguchi, Japan
Iwakuni, Yamaguchi, Japan
Nagato, Yamaguchi, Japan
Shimonoseki, Yamaguchi, Japan
Chūō, Yamanashi, Japan
Kofu, Yamanashi, Japan
Minamikoma, Yamanashi, 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
Okayama, , Japan
Okinawa, , Japan
Osaka, , Japan
Ōita, , Japan
Saga, , Japan
Saitama, , Japan
Shizuoka, , Japan
Tokushima, , Japan
Tottori, , Japan
Toyama, , Japan
Countries
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References
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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.
Other Identifiers
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HAL01S
Identifier Type: -
Identifier Source: org_study_id
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