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NCT02371174

Post-Marketing Surveillance Study of Eribulin on the Status and Factors for the Development of Peripheral Neuropathy in Japan.

Completed Last updated 13 July 2018
What this trial tests

trial in Breast Cancer in 651 participants. Completed in 21 January 2018.

Timeline
3 September 2014
Primary endpoint
21 January 2018
21 January 2018

Quick facts

Lead sponsorEisai Co., Ltd.
StatusCompleted
Study typeOBSERVATIONAL
Enrollment651
Start date3 September 2014
Primary completion21 January 2018
Estimated completion21 January 2018
Sites2 locations across Japan

Conditions studied

Sponsor

Eisai Co., Ltd. — full company profile →

Who can join

Eligibility, female only, with Breast Cancer or HER2-negative Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Eribulin in Cancer Treatment.
    Swami U, Shah U, Goel S. · · 2015 · cited 46× · PMID 26262627 · DOI 10.3390/md13085016
  2. Effectiveness and safety of eribulin in Japanese patients with HER2-negative, advanced breast cancer: a 2-year post-marketing observational study in a real-world setting.
    Inoue K, Takahashi M, Mukai H, Yamanaka T, et al · · 2020 · cited 15× · PMID 31950374 · DOI 10.1007/s10637-019-00890-5
  3. Indices of peripheral leukocytes predict longer overall survival in breast cancer patients on eribulin in Japan.
    Takahashi M, Inoue K, Mukai H, Yamanaka T, et al · · 2021 · cited 12× · PMID 33677779 · DOI 10.1007/s12282-021-01232-1
  4. Chemotherapy-induced peripheral neuropathy in breast cancer patients treated with eribulin: interim data from a post-marketing observational study.
    Tsurutani J, Sakata Y, Matsuoka T. · · 2019 · cited 11× · PMID 30324551 · DOI 10.1007/s12282-018-0919-8
  5. Prognosis of Invasive Lobular Carcinoma and Effectiveness of Eribulin in Clinical Practice: A Post Hoc Analysis of a 2-Year Post-Marketing Surveillance.
    Tanabe Y, Inoue K, Takahashi M, Mukai H, et al · · 2025 · cited 1× · PMID 40404608 · DOI 10.1111/ajco.14189

Verify or expand the search:

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

Other Eisai Co., Ltd. trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02371174.

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