Phase II study of the combination of Eribulin and Trastuzumab Evaluating Efficacy and Safety in Patients with advanced/recurrent HER2-positive breast cancer.

Phase II study of the combination of Eribulin and Trastuzumab Evaluating Efficacy and Safety in Patients with advanced/recurrent HER2-positive breast cancer. - Phase II study of the combination of Eribulin and Trastuzumab Evaluating Efficacy and Safety in Patients with advanced/recurrent HER2-positive breast cancer.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011020

Enrollment

Registered

2013-06-24

Start date

2013-06-24

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

Advanced/recurrent HER2-positive breast cancer

Interventions

Eribulin 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle. Administration trasutuzumab every 3week with a starting dose of 8mg/kg followed by 6mg/kg as the s

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1)female patient who were histologically confirmed as breast cancer 2)previously treated with combination chemotherapeutic and anti-HER2 therapy 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) AST,ALT of the patient with the metastasis to liver less than 5.0 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
Objective Response Rate	—

Secondary

Measure	Time frame
Clinical Benefit Rate Overall Survival Progression Free Survival Time to Treament Failure Safety	—

Countries

Japan

Contacts

Public ContactToshihiro Kai

Sairtama 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