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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events and serious adverse events | 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. | Baseline, and every two months after the initial dose of HALAVEN up to 2 years |
| Number of participants with adverse drug reactions | Baseline and up to 2 years after the initial dose of HALAVEN | |
| Time to onset of peripheral neuropathy | Baseline and up to 2 years after the initial dose of HALAVEN | |
| Time to resolution of peripheral neuropathy | Baseline and up to 2 years after the initial dose of HALAVEN |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Up to 2 years |
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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.
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HER2-negative subjects who are treated with HALAVEN for the first time.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osaka | Japan | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40404608 | Derived | 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. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Tokyo |
| Japan |
| D017437 |
| Skin and Connective Tissue Diseases |