Clinical trial · Observational
Post-Marketing Surveillance Study of Eribulin on the Status and Factors for the Development of Peripheral Neuropathy in Japan.
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| HER2-negative Breast Cancer | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- HALAVEN treatment group of primary or secondary chemotherapy
- description
- Patients with HER2-negative recurrent breast cancer who have received 0 or 1 chemotherapy regimen for recurrent breast cancer.
- label
- HALAVEN treatment group of tertiary or later chemotherapy
- description
- Patients with HER2-negative inoperable or recurrent breast cancer who have received 2 or more chemotherapy regimens for inoperable or recurrent breast cancer.
Primary outcomes (5)
- measure
- Number of participants with adverse events and serious adverse events
- timeFrame
- Baseline and up to 2 years after the initial dose of HALAVEN
- measure
- Number of participants with peripheral neuropathy
- timeFrame
- Baseline, and every two months after the initial dose of HALAVEN up to 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion criteria: Patients with HER2-negative inoperable or recurrent breast cancer. Exclusion criteria: 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.
References
Publications (1)
- DERIVEDTanabe 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. PMID 40404608