Clinical trial NCT01463891: Post-marketing Surveillance for the Clinical Safety and Effectiveness of Eribulin Mesylate in Patients With Inoperable or Recurrent Breast Cancer (Study HAL01S)
Official title: Post-marketing Surveillance for the Clinical Safety and Effectiveness of Eribulin Mesylate in Patients With Inoperable or Recurrent Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inoperable or Recurrent Breast Cancer
Keywords: Eribulin Mesylate
inoperable or recurrent breast cancer
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2011-11-02
Enrollment: 963
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitals and clinics in Japan

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


Eligibility criteria: 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

Primary outcomes:
measure: Effectiveness Diagnosed by Imaging
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Anjo
country: Japan
state: Aichi
city: Inazawa
country: Japan
state: Aichi
city: Kariya
country: Japan
state: Aichi
city: Komaki
country: Japan
state: Aichi
city: Nagakute
country: Japan
state: Aichi
city: Nagoya
country: Japan
state: Aichi
city: Okazaki
country: Japan
state: Aichi
city: Seto
country: Japan
state: Aichi
city: Tahara
country: Japan
state: Aichi
city: Toyohashi
country: Japan
state: Aichi
city: Daisen
country: Japan
state: Akita
city: Yokote
country: Japan
state: Akita
city: Goshogawara
country: Japan
state: Aomori
city: Hirosaki
country: Japan
state: Aomori
city: Kuroishi
country: Japan
state: Aomori
city: Misawa
country: Japan
state: Aomori
city: Mutsu
country: Japan
state: Aomori
city: Asahi
country: Japan
state: Chiba
city: Funabashi
country: Japan
state: Chiba
city: Ichihara
country: Japan
state: Chiba
city: Ichikawa
country: Japan
state: Chiba
city: Kashiwa
country: Japan
state: Chiba
city: Kimitsu
country: Japan
state: Chiba
city: Matsudo
country: Japan
state: Chiba
city: Sakura
country: Japan
state: Chiba
city: Matsuyama
country: Japan
state: Ehime
city: Niihama
country: Japan
state: Ehime
city: Iizuka
country: Japan
state: Fukuoka
city: Kasuga
country: Japan
state: Fukuoka
city: Kitakyushu
country: Japan
state: Fukuoka
city: Kurume
country: Japan
state: Fukuoka
city: Omuta
country: Japan
state: Fukuoka
city: Yame
country: Japan
state: Fukuoka
city: Yanagawa
country: Japan
state: Fukuoka
city: Minamisoma
country: Japan
state: Fukushima
city: Nihonmatsu
country: Japan
state: Fukushima
city: Ena
country: Japan
state: Gifu
city: Hashima
country: Japan
state: Gifu
city: Minokamo
country: Japan
state: Gifu
city: Ogaki
country: Japan
state: Gifu
city: Seki
country: Japan
state: Gifu
city: Tajimi
country: Japan
state: Gifu
city: Takayama
country: Japan
state: Gifu
city: Maebashi
country: Japan
state: Gumma
city: Ota
country: Japan
state: Gumma
city: Shibukawa
country: Japan
state: Gumma
city: Takasaki
country: Japan
state: Gumma
city: Aki
country: Japan
state: Hiroshima
city: Fukuyama
country: Japan
state: Hiroshima
city: Hatsukaichi
country: Japan
state: Hiroshima
city: Higashihiroshima
country: Japan
state: Hiroshima
city: Kure
country: Japan
state: Hiroshima
city: Mihara
country: Japan
state: Hiroshima
city: Onomichi
country: Japan
state: Hiroshima
city: Abashiri
country: Japan
state: Hokkaido
city: Asahikawa
country: Japan
state: Hokkaido
city: Date
country: Japan
state: Hokkaido
city: Eniwa
country: Japan
state: Hokkaido
city: Hakodate
country: Japan
state: Hokkaido
city: Kitahiroshima
country: Japan
state: Hokkaido
city: Kitami
country: Japan
state: Hokkaido
city: Kushiro
country: Japan
state: Hokkaido
city: Muroran
country: Japan
state: Hokkaido
city: Obihiro
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Shibetsu
country: Japan
state: Hokkaido
city: Akashi
country: Japan
state: Hyogo
city: Amagasaki
country: Japan
state: Hyogo
city: Himeji
country: Japan
state: Hyogo
city: Kobe
country: Japan
state: Hyogo
city: Nishinomiya
country: Japan
state: Hyogo
city: Toyooka
country: Japan
state: Hyogo
city: Higashiibaraki
country: Japan
state: Ibaraki
city: Inashiki
country: Japan
state: Ibaraki
city: Kamisu
country: Japan
state: Ibaraki
city: Kasama
country: Japan
state: Ibaraki
city: Koga
country: Japan
state: Ibaraki
city: Moriya
country: Japan
state: Ibaraki
city: Tsukuba
country: Japan
state: Ibaraki
city: Ushiku
country: Japan
state: Ibaraki
city: Kahoku
country: Japan
state: Ishikawa
city: Kanazawa
country: Japan
state: Ishikawa
city: Komatsu
country: Japan
state: Ishikawa
city: Nomi
country: Japan
state: Ishikawa
city: Takamatsu
country: Japan
state: Kagawa
city: Akune
country: Japan
state: Kagoshima
city: Chigasaki
country: Japan
state: Kanagawa
city: Ebina
country: Japan
state: Kanagawa
city: Isehara
country: Japan
state: Kanagawa
city: Kamakura
country: Japan
state: Kanagawa
city: Kawasaki
country: Japan
state: Kanagawa
city: Odawara
country: Japan
state: Kanagawa
city: Sagamihara
country: Japan
state: Kanagawa
city: Yokohama
country: Japan
state: Kanagawa
city: Yokosuka
country: Japan
state: Kanagawa
city: Arao
country: Japan
state: Kumamoto
city: Tamana
country: Japan
state: Kumamoto
city: Nagaokakyo
country: Japan
state: Kyoto
city: Ise
country: Japan
state: Mie
city: Matsusaka
country: Japan
state: Mie
city: Suzuka
country: Japan
state: Mie
city: Tsu
country: Japan
state: Mie
city: Yokkaichi
country: Japan
state: Mie
city: Osaki
country: Japan
state: Miyagi
city: Sendai
country: Japan
state: Miyagi
city: Shibata
country: Japan
state: Miyagi
city: Iida
country: Japan
state: Nagano
city: Komagane
country: Japan
state: Nagano
city: Matsumoto
country: Japan
state: Nagano
city: Saku
country: Japan
state: Nagano
city: Suwa
country: Japan
state: Nagano
city: Shimabara
country: Japan
state: Nagasaki
city: Ikoma
country: Japan
state: Nara
city: Kashihara
country: Japan
state: Nara
city: Yamatotakada
country: Japan
state: Nara
city: Minamiuonuma
country: Japan
state: Niigata
city: Kurashiki
country: Japan
state: Okayama
city: Maniwa
country: Japan
state: Okayama
city: Tamano
country: Japan
state: Okayama
city: Wake
country: Japan
state: Okayama
city: Naha
country: Japan
state: Okinawa
city: Nakagami
country: Japan
state: Okinawa
city: Shimajiri
country: Japan
state: Okinawa
city: Tomigusuku
country: Japan
state: Okinawa
city: Urasoe
country: Japan
state: Okinawa
city: Higashiosaka
country: Japan
state: Osaka
city: Hirakata
country: Japan
state: Osaka
city: Ibaraki
country: Japan
state: Osaka
city: Izumiotsu
country: Japan
state: Osaka
city: Katano
country: Japan
state: Osaka
city: Neyagawa
country: Japan
state: Osaka
city: Osakasayama
country: Japan
state: Osaka
city: Takatsuki
country: Japan
state: Osaka
city: Yao
country: Japan
state: Osaka
city: Karatsu
country: Japan
state: Saga
city: Fujimino
country: Japan
state: Saitama
city: Fukaya
country: Japan
state: Saitama
city: Hidaka
country: Japan
state: Saitama
city: Hiki
country: Japan
state: Saitama
city: Kawaguchi
country: Japan
state: Saitama
city: Kumagaya
country: Japan
state: Saitama
city: Toda
country: Japan
state: Saitama
city: Tokorozawa
country: Japan
state: Saitama
city: Kusatsu
country: Japan
state: Shiga
city: Otsu
country: Japan
state: Shiga
city: Ritto
country: Japan
state: Shiga
city: Izumo
country: Japan
state: Shimane
city: Matsue
country: Japan
state: Shimane
city: Fujieda
country: Japan
state: Shizuoka
city: Fujinomiya
country: Japan
state: Shizuoka
city: Gotemba
country: Japan
state: Shizuoka
city: Hamamatsu
country: Japan
state: Shizuoka
city: Izunokuni
country: Japan
state: Shizuoka
city: Numazu
country: Japan
state: Shizuoka
city: Shimada
country: Japan
state: Shizuoka
city: Sunto
country: Japan
state: Shizuoka
city: Ashikaga
country: Japan
state: Tochigi
city: Oyama
country: Japan
state: Tochigi
city: Adachi
country: Japan
state: Tokyo
city: Akishima
country: Japan
state: Tokyo
city: Bunkyo
country: Japan
state: Tokyo
city: Chiyoda
country: Japan
state: Tokyo
city: Chuo
country: Japan
state: Tokyo
city: Fuchu
country: Japan
state: Tokyo
city: Fussa
country: Japan
state: Tokyo
city: Hachioji
country: Japan
state: Tokyo
city: Hino
country: Japan
state: Tokyo
city: Itabashi
country: Japan
state: Tokyo
city: Katsushika
country: Japan
state: Tokyo
city: Kita
country: Japan
state: Tokyo
city: Koto
country: Japan
state: Tokyo
city: Machida
country: Japan
state: Tokyo
city: Meguro
country: Japan
state: Tokyo
city: Minato
country: Japan
state: Tokyo
city: Mitaka
country: Japan
state: Tokyo
city: Nerima
country: Japan
state: Tokyo
city: Ota
country: Japan
state: Tokyo
city: Setagaya
country: Japan
state: Tokyo
city: Shibuya
country: Japan
state: Tokyo
city: Shinagawa
country: Japan
state: Tokyo
city: Shinjuku
country: Japan
state: Tokyo
city: Tachikawa
country: Japan
state: Tokyo
city: Taito
country: Japan
state: Tokyo
city: Tama
country: Japan
state: Tokyo
city: Kurayoshi
country: Japan
state: Tottori
city: Yonago
country: Japan
state: Tottori
city: Nakaniikawa
country: Japan
state: Toyama
city: Namerikawa
country: Japan
state: Toyama
city: Oyabe
country: Japan
state: Toyama
city: Takaoka
country: Japan
state: Toyama
city: Tsuruoka
country: Japan
state: Yamagata
city: Hagi
country: Japan
state: Yamaguchi
city: Iwakuni
country: Japan
state: Yamaguchi
city: Nagato
country: Japan
state: Yamaguchi
city: Shimonoseki
country: Japan
state: Yamaguchi
city: Chuo
country: Japan
state: Yamanashi
city: Kofu
country: Japan
state: Yamanashi
city: Minamikoma
country: Japan
state: Yamanashi
city: Aomori
country: Japan
city: Chiba
country: Japan
city: Fukui
country: Japan
city: Fukuoka
country: Japan
city: Fukushima
country: Japan
city: Gifu
country: Japan
city: Hiroshima
country: Japan
city: Kagoshima
country: Japan
city: Kochi
country: Japan
city: Kumamoto
country: Japan
city: Kyoto
country: Japan
city: Miyazaki
country: Japan
city: Nagano
country: Japan
city: Nagasaki
country: Japan
city: Niigata
country: Japan
city: Oita
country: Japan
city: Okayama
country: Japan
city: Okinawa
country: Japan
city: Osaka
country: Japan
city: Saga
country: Japan
city: Saitama
country: Japan
city: Shizuoka
country: Japan
city: Tokushima
country: Japan
city: Tottori
country: Japan
city: Toyama
country: Japan
Study officials:
affiliation: Drug Fostering and Evolution Cordination Department, Eisai Co., Ltd.
name: Toshiyuki Matsuoka
role: STUDY_DIRECTOR
References:
citation: 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.