Phase II clinical study of eribulin monotherapy in Japanese patients with metastatic breast cancer who presented well-defined taxane resistance

Phase II clinical study of eribulin monotherapy in Japanese patients with metastatic breast cancer who presented well-defined taxane resistance - Phase II clinical study of eribulin monotherapy in Japanese patients with metastatic breast cancer who presented well-defined taxane resistance

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006965

Enrollment

Registered

2012-01-04

Start date

2012-01-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Interventions

1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1)female patient who were histologically or cytologically confirmed as breast cancer 2)previously treated with chemotherapeutic regimens including an anthracycline and a taxane: relapse during or within a year after neoadjuvant or post-operative adjuvant chemothrapy with a taxane immediately before the study progression during chemothrapy with a taxane in the metastatic setting 3)aged more than 20years and less than 75 years 4)ECOG PS of 0-2 5)having measurable lesion according to RECIST 6)adequate organ functions confirmed with following major examination: neutrophil count more than 1500/microl platelet count more than 100,000/microl hemoglobin more than 8.0g/dL AST,ALT less than 2.5 times the upper limit of nomal (ULN) total bilirubin less than 1.5 times the upper limit of nomal (ULN) serum creatinine less than 1.5 times the upper llimit of nomal (ULN) 7)obtained written informed consent

Exclusion criteria

Exclusion criteria: 1)having systemic infection with a fever of 38 degrees or more 2)pleural effusion, ascites, or pericardial fluid requiring drainage 3)brain metastasis with clinical symptoms 4)patient with following serious complication ischaemic heart disease or heart disease such as arrhythmia not controllable by treatment myocardial infarction < 6 months prior to study entry hepatic cirrhosis interstitial pneumonia or pulmonary fibrosis bleeding tendency 5)having active double cancer 6)HER2 over-expressed 7)pregnancy, breast-feeding or women with childbearing potential 8)judged by the investigator not to be appropriate for the study

Design outcomes

Primary

Measure	Time frame
Clinical Benefit Rate	—

Secondary

Measure	Time frame
EORTC QLQ-C30 Progression Free Survival Overall Survival Safety	—

Countries

Japan

Contacts

Public ContactToshihiro Kai

Saitama Breast Cancer Clinical Study Group (SBCCSG) Secretariat Division (Shintoshin Ladies' Mammo Clinic)

toshikai@sbccsg.org048-600-1722

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026