Post-marketing Surveillance for the Clinical Safety and Effectiveness of Eribulin Mesylate in Patients With Inoperable or Recurrent Breast Cancer (Study HAL01S)
1 other identifier
observational
963
1 country
223
Brief Summary
To investigate of the clinical safety and effectiveness of eribulin mesylate in patients with inoperable or recurrent breast cancer
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2011
Typical duration for all trials
223 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 19, 2011
CompletedFirst Submitted
Initial submission to the registry
September 29, 2011
CompletedFirst Posted
Study publicly available on registry
November 2, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 26, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 27, 2013
CompletedJuly 24, 2023
December 1, 2016
1.4 years
September 29, 2011
July 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Eribulin Mesylate
Interventions
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
Hospitals and clinics in Japan
You may qualify if:
- Inoperable breast cancer
- Recurrent breast cancer
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Co., Ltd.lead
Study Sites (223)
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Anjo, Aichi-ken, Japan
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Inazawa, Aichi-ken, Japan
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Kariya, Aichi-ken, Japan
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Komaki, Aichi-ken, Japan
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Nagakute, Aichi-ken, Japan
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Nagoya, Aichi-ken, Japan
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Okazaki, Aichi-ken, Japan
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Seto, Aichi-ken, Japan
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Tahara, Aichi-ken, Japan
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Toyohashi, Aichi-ken, Japan
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Daisen, Akita, Japan
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Yokote, Akita, Japan
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Goshogawara, Aomori, Japan
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Hirosaki, Aomori, Japan
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Kuroishi, Aomori, Japan
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Misawa, Aomori, Japan
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Mutsu, Aomori, Japan
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Asahi, Chiba, Japan
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Funabashi, Chiba, Japan
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Ichihara, Chiba, Japan
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Ichikawa, Chiba, Japan
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Kashiwa, Chiba, Japan
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Kimitsu, Chiba, Japan
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Matsudo, Chiba, Japan
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Sakura, Chiba, Japan
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Matsuyama, Ehime, Japan
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Niihama, Ehime, Japan
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Iizuka, Fukuoka, Japan
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Kasuga, Fukuoka, Japan
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Kitakyushu, Fukuoka, Japan
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Kurume, Fukuoka, Japan
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Omuta, Fukuoka, Japan
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Yame, Fukuoka, Japan
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Yanagawa, Fukuoka, Japan
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Minamisoma, Fukushima, Japan
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Nihommatsu, Fukushima, Japan
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Ena, Gifu, Japan
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Hashima, Gifu, Japan
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Minokamo, Gifu, Japan
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Ōgaki, Gifu, Japan
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Sekimachi, Gifu, Japan
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Tajimi, Gifu, Japan
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Takayama, Gifu, Japan
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Maebashi, Gunma, Japan
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Ōta, Gunma, Japan
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Shibukawa, Gunma, Japan
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Takasaki, Gunma, Japan
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Aki, Hiroshima, Japan
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Fukuyama, Hiroshima, Japan
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Hatsukaichi, Hiroshima, Japan
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Higashihiroshima, Hiroshima, Japan
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Kure, Hiroshima, Japan
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Mihara, Hiroshima, Japan
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Onomichi, Hiroshima, Japan
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Abashiri, Hokkaido, Japan
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Asahikawa, Hokkaido, Japan
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Date, Hokkaido, Japan
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Eniwa, Hokkaido, Japan
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Hakodate, Hokkaido, Japan
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Kitahiroshima, Hokkaido, Japan
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Kitami, Hokkaido, Japan
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Kushiro, Hokkaido, Japan
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Muroran, Hokkaido, Japan
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Obihiro, Hokkaido, Japan
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Sapporo, Hokkaido, Japan
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Shibetsu, Hokkaido, Japan
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Akashi, Hyōgo, Japan
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Amagasaki, Hyōgo, Japan
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Himeji, Hyōgo, Japan
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Kobe, Hyōgo, Japan
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Nishinomiya, Hyōgo, Japan
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Toyooka, Hyōgo, Japan
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Higashiibaraki, Ibaraki, Japan
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Inashiki, Ibaraki, Japan
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Kamisu, Ibaraki, Japan
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Kasama, Ibaraki, Japan
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Koga, Ibaraki, Japan
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Moriya, Ibaraki, Japan
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Tsukuba, Ibaraki, Japan
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Ushiku, Ibaraki, Japan
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Kahoku, Ishikawa-ken, Japan
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Kanazawa, Ishikawa-ken, Japan
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Komatsu, Ishikawa-ken, Japan
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Nomi, Ishikawa-ken, Japan
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Takamatsu, Kagawa-ken, Japan
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Akune, Kagoshima-ken, Japan
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Chigasaki, Kanagawa, Japan
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Ebina, Kanagawa, Japan
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Isehara, Kanagawa, Japan
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Kamakura, Kanagawa, Japan
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Kawasaki, Kanagawa, Japan
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Odawara, Kanagawa, Japan
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Sagamihara, Kanagawa, Japan
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Yokohama, Kanagawa, Japan
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Yokosuka, Kanagawa, Japan
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Arao, Kumamoto, Japan
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Tamana, Kumamoto, Japan
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Kōtari, Kyoto, Japan
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Ise, Mie-ken, Japan
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Matsusaka, Mie-ken, Japan
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Suzuka, Mie-ken, Japan
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Tsu, Mie-ken, Japan
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Yokkaichi, Mie-ken, Japan
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Murata, Miyagi, Japan
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Ōsaki, Miyagi, Japan
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Sendai, Miyagi, Japan
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Iida, Nagano, Japan
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Komagane, Nagano, Japan
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Matsumoto, Nagano, Japan
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Saku, Nagano, Japan
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Suwa, Nagano, Japan
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Shimabara, Nagasaki, Japan
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Ikoma, Nara, Japan
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Kashihara, Nara, Japan
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Yamatotakada, Nara, Japan
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Minamiuonuma, Niigata, Japan
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Kurashiki, Okayama-ken, Japan
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Maniwa, Okayama-ken, Japan
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Tamano, Okayama-ken, Japan
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Wake, Okayama-ken, Japan
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Naha, Okinawa, Japan
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Nakagami, Okinawa, Japan
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Shimajiri, Okinawa, Japan
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Tomigusuku, Okinawa, Japan
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Urasoe, Okinawa, Japan
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Higashiosaka, Osaka, Japan
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Hirakata, Osaka, Japan
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Ibaraki, Osaka, Japan
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Izumiōtsu, Osaka, Japan
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Katano, Osaka, Japan
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Neyagawa, Osaka, Japan
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Sayama, Osaka, Japan
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Takatsuki, Osaka, Japan
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Yao, Osaka, Japan
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Karatsu, Saga-ken, Japan
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Fujimino, Saitama, Japan
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Fukaya, Saitama, Japan
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Hidaka, Saitama, Japan
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Hiki, Saitama, Japan
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Kawaguchi, Saitama, Japan
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Kumagaya, Saitama, Japan
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Toda, Saitama, Japan
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Tokorozawa, Saitama, Japan
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Kusatsu, Shiga, Japan
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Ōtsu, Shiga, Japan
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Rittō, Shiga, Japan
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Izumo, Shimane, Japan
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Matsue, Shimane, Japan
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Fujieda, Shizuoka, Japan
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Fujinomiya, Shizuoka, Japan
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Gotemba, Shizuoka, Japan
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Hamamatsu, Shizuoka, Japan
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Izunokuni, Shizuoka, Japan
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Numazu, Shizuoka, Japan
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Shimada, Shizuoka, Japan
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Sunto, Shizuoka, Japan
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Ashikaga, Tochigi, Japan
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Oyama, Tochigi, Japan
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Adachi City, Tokyo, Japan
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Akishima, Tokyo, Japan
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Bunkyo, Tokyo, Japan
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Chiyoda City, Tokyo, Japan
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Chūō, Tokyo, Japan
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Fuchū, Tokyo, Japan
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Fussa, Tokyo, Japan
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Hachiōji, Tokyo, Japan
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Hino, Tokyo, Japan
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Katsushika-ku, Tokyo, Japan
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Kita-ku, Tokyo, Japan
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Koto, Tokyo, Japan
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Machida, Tokyo, Japan
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Meguro City, Tokyo, Japan
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Minato, Tokyo, Japan
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Mitaka, Tokyo, Japan
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Nerima City, Tokyo, Japan
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Ōta-ku, Tokyo, Japan
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Setagaya City, Tokyo, Japan
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Shibuya City, Tokyo, Japan
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Shinagawa, Tokyo, Japan
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Shinjuku, Tokyo, Japan
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tabashi City, Tokyo, Japan
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Tachikawa, Tokyo, Japan
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Taitō City, Tokyo, Japan
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Tama, Tokyo, Japan
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Kurayoshi, Tottori, Japan
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Yonago, Tottori, Japan
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Nakaniikawa, Toyama, Japan
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Namerikawa, Toyama, Japan
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Oyabe, Toyama, Japan
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Takaoka, Toyama, Japan
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Tsuruoka, Yamagata, Japan
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Hagi, Yamaguchi, Japan
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Iwakuni, Yamaguchi, Japan
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Nagato, Yamaguchi, Japan
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Shimonoseki, Yamaguchi, Japan
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Chūō, Yamanashi, Japan
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Kofu, Yamanashi, Japan
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Minamikoma, Yamanashi, Japan
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Aomori, Japan
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Chiba, Japan
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Fukui, Japan
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Fukuoka, Japan
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Fukushima, Japan
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Gifu, Japan
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Hiroshima, Japan
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Kagoshima, Japan
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Kochi, Japan
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Kumamoto, Japan
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Kyoto, Japan
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Miyazaki, Japan
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Nagano, Japan
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Nagasaki, Japan
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Niigata, Japan
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Okayama, Japan
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Okinawa, Japan
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Osaka, Japan
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Ōita, Japan
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Saga, Japan
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Saitama, Japan
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Shizuoka, Japan
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Tokushima, Japan
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Tottori, Japan
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Toyama, Japan
Related Publications (1)
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.
PMID: 28660549RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Toshiyuki Matsuoka
Drug Fostering and Evolution Cordination Department, Eisai Co., Ltd.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2011
First Posted
November 2, 2011
Study Start
July 19, 2011
Primary Completion
December 26, 2012
Study Completion
November 27, 2013
Last Updated
July 24, 2023
Record last verified: 2016-12