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Inoperable or Recurrent Breast CancerNCT01463891

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

An observational study of Inoperable or Recurrent Breast Cancer, run by Eisai Co., Ltd. at 223 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

To investigate of the clinical safety and effectiveness of eribulin mesylate in patients with inoperable or recurrent breast cancer Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Inoperable or Recurrent Breast Cancer
What is being tested?
Eribulin Mesylate
Type of treatment
Injection or infusion
How many people
963 participants
Where
223 sitesJapan
Study dates
19 Jul 2011to 27 Nov 2013
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Hospitals and clinics in Japan

Who may be able to join

  • Inoperable breast cancer
  • Recurrent breast cancer

Who cannot join

  • 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

Trial locations and contacts

223 sites in 1 country.

223 sites in 1 country

Japan223 sites

  • Study site

    Abashiri, Hokkaido

  • Study site

    Adachi City, Tokyo

  • Study site

    Akashi, Hyōgo

  • Study site

    Aki, Hiroshima

  • Study site

    Akishima, Tokyo

  • Study site

    Akune, Kagoshima-ken

  • Study site

    Amagasaki, Hyōgo

  • Study site

    Anjo, Aichi-ken

  • Study site

    Aomori

  • Study site

    Arao, Kumamoto

  • Study site

    Asahi, Chiba

  • Study site

    Asahikawa, Hokkaido

  • Study site

    Ashikaga, Tochigi

  • Study site

    Bunkyo, Tokyo

  • Study site

    Chiba

  • Study site

    Chigasaki, Kanagawa

  • Study site

    Chiyoda City, Tokyo

  • Study site

    Chūō, Tokyo

  • Study site

    Chūō, Yamanashi

  • Study site

    Daisen, Akita

  • Study site

    Date, Hokkaido

  • Study site

    Ebina, Kanagawa

  • Study site

    Ena, Gifu

  • Study site

    Eniwa, Hokkaido

  • Study site

    Fuchū, Tokyo

  • Study site

    Fujieda, Shizuoka

  • Study site

    Fujimino, Saitama

  • Study site

    Fujinomiya, Shizuoka

  • Study site

    Fukaya, Saitama

  • Study site

    Fukui

  • Study site

    Fukuoka

  • Study site

    Fukushima

  • Study site

    Fukuyama, Hiroshima

  • Study site

    Funabashi, Chiba

  • Study site

    Fussa, Tokyo

  • Study site

    Gifu

  • Study site

    Goshogawara, Aomori

  • Study site

    Gotemba, Shizuoka

  • Study site

    Hachiōji, Tokyo

  • Study site

    Hagi, Yamaguchi

  • Study site

    Hakodate, Hokkaido

  • Study site

    Hamamatsu, Shizuoka

  • Study site

    Hashima, Gifu

  • Study site

    Hatsukaichi, Hiroshima

  • Study site

    Hidaka, Saitama

  • Study site

    Higashihiroshima, Hiroshima

  • Study site

    Higashiibaraki, Ibaraki

  • Study site

    Higashiosaka, Osaka

  • Study site

    Hiki, Saitama

  • Study site

    Himeji, Hyōgo

  • Study site

    Hino, Tokyo

  • Study site

    Hirakata, Osaka

  • Study site

    Hirosaki, Aomori

  • Study site

    Hiroshima

  • Study site

    Ibaraki, Osaka

  • Study site

    Ichihara, Chiba

  • Study site

    Ichikawa, Chiba

  • Study site

    Iida, Nagano

  • Study site

    Iizuka, Fukuoka

  • Study site

    Ikoma, Nara

  • Study site

    Inashiki, Ibaraki

  • Study site

    Inazawa, Aichi-ken

  • Study site

    Ise, Mie-ken

  • Study site

    Isehara, Kanagawa

  • Study site

    Iwakuni, Yamaguchi

  • Study site

    Izumiōtsu, Osaka

  • Study site

    Izumo, Shimane

  • Study site

    Izunokuni, Shizuoka

  • Study site

    Kagoshima

  • Study site

    Kahoku, Ishikawa-ken

  • Study site

    Kamakura, Kanagawa

  • Study site

    Kamisu, Ibaraki

  • Study site

    Kanazawa, Ishikawa-ken

  • Study site

    Karatsu, Saga-ken

  • Study site

    Kariya, Aichi-ken

  • Study site

    Kasama, Ibaraki

  • Study site

    Kashihara, Nara

  • Study site

    Kashiwa, Chiba

  • Study site

    Kasuga, Fukuoka

  • Study site

    Katano, Osaka

  • Study site

    Katsushika-ku, Tokyo

  • Study site

    Kawaguchi, Saitama

  • Study site

    Kawasaki, Kanagawa

  • Study site

    Kimitsu, Chiba

  • Study site

    Kita-ku, Tokyo

  • Study site

    Kitahiroshima, Hokkaido

  • Study site

    Kitakyushu, Fukuoka

  • Study site

    Kitami, Hokkaido

  • Study site

    Kobe, Hyōgo

  • Study site

    Kochi

  • Study site

    Kofu, Yamanashi

  • Study site

    Koga, Ibaraki

  • Study site

    Komagane, Nagano

  • Study site

    Komaki, Aichi-ken

  • Study site

    Komatsu, Ishikawa-ken

  • Study site

    Kōtari, Kyoto

  • Study site

    Koto, Tokyo

  • Study site

    Kumagaya, Saitama

  • Study site

    Kumamoto

  • Study site

    Kurashiki, Okayama-ken

  • Study site

    Kurayoshi, Tottori

  • Study site

    Kure, Hiroshima

  • Study site

    Kuroishi, Aomori

  • Study site

    Kurume, Fukuoka

  • Study site

    Kusatsu, Shiga

  • Study site

    Kushiro, Hokkaido

  • Study site

    Kyoto

  • Study site

    Machida, Tokyo

  • Study site

    Maebashi, Gunma

  • Study site

    Maniwa, Okayama-ken

  • Study site

    Matsudo, Chiba

  • Study site

    Matsue, Shimane

  • Study site

    Matsumoto, Nagano

  • Study site

    Matsusaka, Mie-ken

  • Study site

    Matsuyama, Ehime

  • Study site

    Meguro City, Tokyo

  • Study site

    Mihara, Hiroshima

  • Study site

    Minamikoma, Yamanashi

  • Study site

    Minamisoma, Fukushima

  • Study site

    Minamiuonuma, Niigata

  • Study site

    Minato, Tokyo

  • Study site

    Minokamo, Gifu

  • Study site

    Misawa, Aomori

  • Study site

    Mitaka, Tokyo

  • Study site

    Miyazaki

  • Study site

    Moriya, Ibaraki

  • Study site

    Murata, Miyagi

  • Study site

    Muroran, Hokkaido

  • Study site

    Mutsu, Aomori

  • Study site

    Nagakute, Aichi-ken

  • Study site

    Nagano

  • Study site

    Nagasaki

  • Study site

    Nagato, Yamaguchi

  • Study site

    Nagoya, Aichi-ken

  • Study site

    Naha, Okinawa

  • Study site

    Nakagami, Okinawa

  • Study site

    Nakaniikawa, Toyama

  • Study site

    Namerikawa, Toyama

  • Study site

    Nerima City, Tokyo

  • Study site

    Neyagawa, Osaka

  • Study site

    Nihommatsu, Fukushima

  • Study site

    Niigata

  • Study site

    Niihama, Ehime

  • Study site

    Nishinomiya, Hyōgo

  • Study site

    Nomi, Ishikawa-ken

  • Study site

    Numazu, Shizuoka

  • Study site

    Obihiro, Hokkaido

  • Study site

    Odawara, Kanagawa

  • Study site

    Ōgaki, Gifu

  • Study site

    Ōita

  • Study site

    Okayama

  • Study site

    Okazaki, Aichi-ken

  • Study site

    Okinawa

  • Study site

    Omuta, Fukuoka

  • Study site

    Onomichi, Hiroshima

  • Study site

    Osaka

  • Study site

    Ōsaki, Miyagi

  • Study site

    Ōta, Gunma

  • Study site

    Ōta-ku, Tokyo

  • Study site

    Ōtsu, Shiga

  • Study site

    Oyabe, Toyama

  • Study site

    Oyama, Tochigi

  • Study site

    Rittō, Shiga

  • Study site

    Saga

  • Study site

    Sagamihara, Kanagawa

  • Study site

    Saitama

  • Study site

    Saku, Nagano

  • Study site

    Sakura, Chiba

  • Study site

    Sapporo, Hokkaido

  • Study site

    Sayama, Osaka

  • Study site

    Sekimachi, Gifu

  • Study site

    Sendai, Miyagi

  • Study site

    Setagaya City, Tokyo

  • Study site

    Seto, Aichi-ken

  • Study site

    Shibetsu, Hokkaido

  • Study site

    Shibukawa, Gunma

  • Study site

    Shibuya City, Tokyo

  • Study site

    Shimabara, Nagasaki

  • Study site

    Shimada, Shizuoka

  • Study site

    Shimajiri, Okinawa

  • Study site

    Shimonoseki, Yamaguchi

  • Study site

    Shinagawa, Tokyo

  • Study site

    Shinjuku, Tokyo

  • Study site

    Shizuoka

  • Study site

    Sunto, Shizuoka

  • Study site

    Suwa, Nagano

  • Study site

    Suzuka, Mie-ken

  • Study site

    tabashi City, Tokyo

  • Study site

    Tachikawa, Tokyo

  • Study site

    Tahara, Aichi-ken

  • Study site

    Taitō City, Tokyo

  • Study site

    Tajimi, Gifu

  • Study site

    Takamatsu, Kagawa-ken

  • Study site

    Takaoka, Toyama

  • Study site

    Takasaki, Gunma

  • Study site

    Takatsuki, Osaka

  • Study site

    Takayama, Gifu

  • Study site

    Tama, Tokyo

  • Study site

    Tamana, Kumamoto

  • Study site

    Tamano, Okayama-ken

  • Study site

    Toda, Saitama

  • Study site

    Tokorozawa, Saitama

  • Study site

    Tokushima

  • Study site

    Tomigusuku, Okinawa

  • Study site

    Tottori

  • Study site

    Toyama

  • Study site

    Toyohashi, Aichi-ken

  • Study site

    Toyooka, Hyōgo

  • Study site

    Tsu, Mie-ken

  • Study site

    Tsukuba, Ibaraki

  • Study site

    Tsuruoka, Yamagata

  • Study site

    Urasoe, Okinawa

  • Study site

    Ushiku, Ibaraki

  • Study site

    Wake, Okayama-ken

  • Study site

    Yamatotakada, Nara

  • Study site

    Yame, Fukuoka

  • Study site

    Yanagawa, Fukuoka

  • Study site

    Yao, Osaka

  • Study site

    Yokkaichi, Mie-ken

  • Study site

    Yokohama, Kanagawa

  • Study site

    Yokosuka, Kanagawa

  • Study site

    Yokote, Akita

  • Study site

    Yonago, Tottori

Other trials in Japan

About this study

Official title: 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

Being tested
Eribulin Mesylate
Keywords
Eribulin Mesylate, inoperable or recurrent breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Eribulin MesylateDrug

    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.

Study groups in NCT01463891
Study groupRoleWhat they receive
Eribulin MesylateNot described
Receives: Drug: Eribulin Mesylate

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2011 (estimated)
  2. Study start19 Jul 2011
  3. Primary completion26 Dec 2012
  4. Study completion27 Nov 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
963 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01463891
Sponsor's protocol ID
HAL01S
Status last verified
Dec 2016
First submitted
29 Sep 2011
Last updated
24 Jul 2023
Results posted
No

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.

    PubMed 28660549

Questions about this trial

What is this clinical trial studying?

An observational study of Inoperable or Recurrent Breast Cancer, run by Eisai Co., Ltd. at 223 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 223 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effectiveness Diagnosed by Imaging (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01463891, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.

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