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

Eisai

Status: Completed

Conditions: Breast Cancer; HER2-negative Breast Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT02371174

HAL02T

Details and patient eligibility

About

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.

Enrollment: 651 patients

Sex: Female

Volunteers: No Healthy Volunteers

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.

Trial design

651 participants in 2 patient groups

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.

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.