Breast CancerNCT02371174
Post-Marketing Surveillance Study of Eribulin on the Status and Factors for the Development of Peripheral Neuropathy in Japan.
An observational study of Breast Cancer and HER2-negative Breast Cancer, run by Eisai Co., Ltd. at 2 sites in Japan.
Trial summary
The primary objective of the study is to clarify factors affecting the incidence of peripheral neuropathy in patients treated with HALAVEN. A total of 590 patients will be enrolled in this study with 295 patients in the treatment group of primary or secondary chemotherapy and 295 patients in the treatment group of… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer, HER2-negative Breast Cancer
- How many people
- 651 participants
- Where
- 2 sitesJapan
- Study dates
- 3 Sep 2014to 21 Jan 2018
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: HER2-negative subjects who are treated with HALAVEN for the first time.
Who may be able to join
- Patients with HER2-negative inoperable or recurrent breast cancer.
Who cannot join
- Patients with high-grade bone marrow depression (absolute neutrophil count less than 1,000 /mm^3, absolute platelet count less than 75,000 /mm^3).
- Patients with a history of hypersensitivity to the ingredients of HALAVEN. Women who are pregnant or may be pregnant. Patients with a history of use of HALAVEN.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: An Observational Post-Marketing Surveillance Study on the Status and Factors for the Development of Peripheral Neuropathy in Patients With HER2-Negative Inoperable or Recurrent Breast Cancer in Japan.
The primary objective of the study is to clarify factors affecting the incidence of peripheral neuropathy in patients treated with HALAVEN. A total of 590 patients will be enrolled in this study with 295 patients in the treatment group of primary or secondary chemotherapy and 295 patients in the treatment group of tertiary or later chemotherapy.
- Conditions
- Breast Cancer, HER2-negative Breast Cancer
- Keywords
- HER2-Negative Inoperable or Recurrent Breast Cancer, Japan, Eribulin Mesylate
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HALAVEN treatment group of primary or secondary chemotherapy | Patients with HER2-negative recurrent breast cancer who have received 0 or 1 chemotherapy regimen for recurrent breast cancer. | |
| HALAVEN treatment group of tertiary or later chemotherapy | Patients with HER2-negative inoperable or recurrent breast cancer who have received 2 or more chemotherapy regimens for inoperable or recurrent breast cancer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events and serious adverse events
Measured: Baseline and up to 2 years after the initial dose of HALAVEN
Number of participants with peripheral neuropathy
Common Terminology Criteria for Adverse Events (CTCAE) grade of peripheral neuropathy is assessed at baseline, and every two months after the initial dose of HALAVEN up to 2 years.
Measured: Baseline, and every two months after the initial dose of HALAVEN up to 2 years
Number of participants with adverse drug reactions
Measured: Baseline and up to 2 years after the initial dose of HALAVEN
Time to onset of peripheral neuropathy
Measured: Baseline and up to 2 years after the initial dose of HALAVEN
Time to resolution of peripheral neuropathy
Measured: Baseline and up to 2 years after the initial dose of HALAVEN
Secondary outcomes (1)
Overall survival
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2015 (estimated)
- Study start3 Sep 2014
- Primary completion21 Jan 2018
- Study completion21 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 651 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02371174
- Sponsor's protocol ID
- HAL02T
- Status last verified
- Jul 2018
- First submitted
- 21 Nov 2014
- Last updated
- 13 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Tanabe Y, Inoue K, Takahashi M, Mukai H, Yamanaka T, Egawa C, Uchida Y, Higashibeppu Y, Sakata Y, Sugawara M, Tsurutani J. Prognosis of Invasive Lobular Carcinoma and Effectiveness of Eribulin in Clinical Practice: A Post Hoc Analysis of a 2-Year Post-Marketing Surveillance. Asia Pac J Clin Oncol. 2025 Dec;21(6):623-630. doi: 10.1111/ajco.14189. Epub 2025 May 22.
PubMed 40404608
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Post-Marketing Surveillance Study on the Status and Factors for the Development of Peripheral Neuropathy in Patients With HER2-Negative Inoperable or Recurrent Breast Cancer in Japan.
- ClinicalTrials.gov ID
- NCT02371174
- Acronym / sponsor ID
- HAL02T
- Conditions
- Breast Cancer, HER2-negative Breast Cancer
- Keywords
- HER2-Negative Inoperable or Recurrent Breast Cancer, Japan, Eribulin Mesylate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 651 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Sep 2014 (actual)
- Primary completion
- 21 Jan 2018 (actual)
- Study completion
- 21 Jan 2018 (actual)
- First posted
- 25 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to clarify factors affecting the incidence of peripheral neuropathy in patients treated with HALAVEN. A total of 590 patients will be enrolled in this study with 295 patients in the treatment group of primary or secondary chemotherapy and 295 patients in the treatment group of tertiary or later chemotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HALAVEN treatment group of primary or secondary chemotherapy | – | –Patients with HER2-negative recurrent breast cancer who have received 0 or 1 chemotherapy regimen for recurrent breast cancer. |
| HALAVEN treatment group of tertiary or later chemotherapy | – | –Patients with HER2-negative inoperable or recurrent breast cancer who have received 2 or more chemotherapy regimens for inoperable or recurrent breast cancer. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- HER2-negative subjects who are treated with HALAVEN for the first time.
Key inclusion criteria (1 listed)
- Patients with HER2-negative inoperable or recurrent breast cancer.
Key exclusion criteria (2 listed)
- Patients with high-grade bone marrow depression (absolute neutrophil count less than 1,000 /mm^3, absolute platelet count less than 75,000 /mm^3).
- Patients with a history of hypersensitivity to the ingredients of HALAVEN. Women who are pregnant or may be pregnant. Patients with a history of use of HALAVEN.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with adverse events and serious adverse events
Time frame: Baseline and up to 2 years after the initial dose of HALAVEN
Number of participants with peripheral neuropathy
Time frame: Baseline, and every two months after the initial dose of HALAVEN up to 2 years
Common Terminology Criteria for Adverse Events (CTCAE) grade of peripheral neuropathy is assessed at baseline, and every two months after the initial dose of HALAVEN up to 2 years.
Number of participants with adverse drug reactions
Time frame: Baseline and up to 2 years after the initial dose of HALAVEN
Time to onset of peripheral neuropathy
Time frame: Baseline and up to 2 years after the initial dose of HALAVEN
Time to resolution of peripheral neuropathy
Time frame: Baseline and up to 2 years after the initial dose of HALAVEN
1 secondary outcome
Overall survival
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2018.
- Derived from this study: PubMed 40404608Tanabe Y, Inoue K, Takahashi M, Mukai H, Yamanaka T, Egawa C, Uchida Y, Higashibeppu Y, Sakata Y, Sugawara M, Tsurutani J. Prognosis of Invasive Lobular Carcinoma and Effectiveness of Eribulin in Clinical Practice: A Post Hoc Analysis of a 2-Year Post-Marketing Surveillance. Asia Pac J Clin Oncol. 2025 Dec;21(6):623-630. doi: 10.1111/ajco.14189. Epub 2025 May 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and HER2-negative Breast Cancer, run by Eisai Co., Ltd. at 2 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 1 inclusion and 2 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 13 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Number of participants with adverse events and serious adverse events (time frame: Baseline and up to 2 years after the initial dose of HALAVEN). The study lists 5 primary outcomes in all. 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 NCT02371174, 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 13 Jul 2018.