A Phase II Study of Eribulin Evaluating Efficacy and Safety as first or secondary line chemotherapy for advanced or metastatic breast cancer without HER2 overexpressing

A Phase II Study of Eribulin Evaluating Efficacy and Safety as first or secondary line chemotherapy for advanced or metastatic breast cancer without HER2 overexpressing - OMC-BC03

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009568

Enrollment

Registered

2012-12-21

Start date

2012-12-01

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

Advanced or metastatic breast cancer

Interventions

December 1, 2012 to December 31, 2015 Eriburin mesylate 1.4mg/m2, Days 1, 8 q21 days.

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. histlogically or cytologically confirmed breast cancer 2. advanced or metastatic breast cancer patient without HER2 overexpressing 3. with interval period of 4 weeks after pot operative adjuvant chemotherapy, 2 weeks after endocrine therapy or radiation 4. with previous treatment by anthracyclin and taxan for peroperative chemotherapy, and without chemotherapy or only one chemotherapy after advanced or metastasis(However, a history of treatment does not matter about some cases that the use of these drugs are not suitable for due to allergies, comorbidity, and other reasons.). 5. with evaluable lesion by RECIST criteria 6. ECOG performance status 0-2 7. required baseline laboratory parameters (within 1 weeks before registration) WBC > 3,000/mm3, neutophil > 1,500/mm3, Plt > 100,000/mm3, Hb > 9.0 g/dL, AST < 2.0 times ULN adn ALT < 2.0 times ULN, serum creatinine < 1.5 times ULN, normal cardiac function 8. with life expectancy greater than 3 months 9. written informed consent was obtained

Exclusion criteria

Exclusion criteria: 1. serious complication or past history: with symptomatic heart failure, ischemic heart disease within 6 months, liver cirrhosis, psychological disorder treated by antipsychotic drug, uncontrolable diabetes, etc 2. active infection 3. The anamnesis of the hypersensitivity to Eribulin 4. peripheral neuropathy greater than Grade 3 5. male breast cancer 6. under pregnancy or breast-feeding, and possibility (will) of pregnancy. 7. with doctors decision for exclusion

Design outcomes

Primary

Measure	Time frame
Objective Response Rate	—

Secondary

Measure	Time frame
Duration of Response, Progression free survival, Overall survival, Safety, QOL	—

Countries

Japan

Contacts

Public ContactMitsuhiko Iwamoto

Osaka Medical College General and Gastroenterological Surgery

sur121@poh.osaka-med.ac.jp072-683-1221

Outcome results

None listed

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