A Phase II, Open-label, Multicenter, Translational Study for Biomarkers of Eribulin Mesylate: Evaluation of the Utility of Monitoring Epithelial-to-Mesenchymal Transition (EMT) Markers on Tumor Cells in the Malignant Plural Effusion of Patients with Metastatic Breast Cancer

A Phase II, Open-label, Multicenter, Translational Study for Biomarkers of Eribulin Mesylate: Evaluation of the Utility of Monitoring Epithelial-to-Mesenchymal Transition (EMT) Markers on Tumor Cells in the Malignant Plural Effusion of Patients with Metastatic Breast Cancer - EXPECT-study

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000022362

Enrollment

Registered

2016-06-01

Start date

2016-04-13

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

Metastatic Breast Cancer

Interventions

Eribulin will be administered at 1.4 mg/m2 on Days (D) 1 and 8 for a 3-week cycle (C) until disease progression or appearance of unmanageable side effect. Concurrent use of anti-HER2 monoclonal antibo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically, cytologically or clinically confirmed MBC 2) Indication of eribulin monotherapy 3) Signed informed consent 4) Age>=20 years 5) Clinically diagnosed as having MPE 6) Indication of MPE drainage 7) Eastern Cooperative Oncology Study Group performance status 0 to 2 8) Having at least one measurable disease or non-measurable bone only diseas as defined by Response Evaluation Criteria in Solid Tumors vesion 1.1 9) Adequate organ function (heart, lung, liver, kidney, bone marrow) 10) Discontinuation of previous therapy (systemic or local) at least 2 weeks proir to enrollment

Exclusion criteria

Exclusion criteria: 1) History of eribulin therapy 2) Pregnant, lactating or woman not agree with contraception within the study period 3) CNS metastasis with symptom or require treatment 4) Active infection excluding well-controlled chronic hepatitis B infection

Design outcomes

Primary

Measure	Time frame
Changes in EMT/MET marker expression between pre- and post-treatment	—

Secondary

Measure	Time frame
Relationship between these changes and the clinical outcome: clinical benefit rate, progression-free survival, and overall survival,	—

Countries

Japan

Contacts

Public ContactIzumi Hirata

Shizuoka Cancer Center Breast Oncology

i.hirata@scchr.jp055-989-5222

Outcome results

None listed

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