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

July 21, 2023 updated by: Eisai Co., Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
963

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Effectiveness Diagnosed by Imaging
Time Frame: 1 year

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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eisai Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Toshiyuki Matsuoka, Drug Fostering and Evolution Cordination Department, Eisai Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 19, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 26, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 27, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2011

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 2, 2011

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 24, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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