A phase II study of eribulin in combination with trastuzumab and pertuzumab as First-Line therapy for metastatic HER2-positive breast cancer

A phase II study of eribulin in combination with trastuzumab and pertuzumab as First-Line therapy for metastatic HER2-positive breast cancer - SBCCSG-36

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000021585

Enrollment

Registered

2016-03-23

Start date

2016-03-24

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

First-Line therapy for metastatic HER2-positive breast cancer.

Interventions

Administration of eribulin,trastuzumab, and pertuzumab every three weeks until disease progression or occurring adverse events difficult to continue.

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1.Histologically confirmed primary breast cancer 2.Age of 18 years and expected survival is more than 6months 3.Histologically confirmed HER2-positive breast cancer in primary lesion or metastatic lesion(Score 3+ by IHC or HER2 Positive by FISH or DISH) 4.First line therapy of Stage IIIB,IIIC,IV or recurrent breast cancer 5.ECOG performance status(PS) 0 or 1(Allow PS 2 due to bone metastases) 6.Clinically confirmed measurable or unmeasurable metastatic lesion except ascites or effusion alone 7.Adequate organ function shown in physical examinations within 14 days prior to enrollment Neutrophil count >=1500/mm3 Platelet count >=75,000/mm3 Hemoglobin >=9.0g/dL Total serum bilirubin <=2.0mg/dL AST and ALT <100IU/L Serum creatinine <=1.5mg/dL 8.No clinical electrocardiographic abnormality 9.Echocardiographic ejection fraction >=55% 10.Subjects who have submitted written informed consent for study entry

Exclusion criteria

Exclusion criteria: 1.Active infection or fever at risk of infection 2.History of serious drug allergies 3.Spontanous serious renal damage or liver dysfunction(jaundice) 4.Large pleural effusion or ascites requiring repeat drainage 5.Systemic administration of steroid drug 6.Pregnant females or females of child-bearing potential 7.Concurrent active other malignancy 8.Metachronous or spontaneous bilateral breast cancer except ductal carcinoma in situ 9.Clinically important mental disorder or history of central nervous system damage 10.Clinically significant central nervous system metastases 11.Concurrent enrollment of other clinical trial 12.Reccurence in conserving breast or local recurrence that is appropriate therapy to reoperate 13.HBs antigen positive 14.Not suitable for participation with any other reasons (including rapid progression disease, life threatening status if not successfully treated)

Design outcomes

Primary

Measure	Time frame
time to chemotherapy treatment failure of response rate	—

Secondary

Measure	Time frame
time to chemotherapy treatment failure, progression free survival, response rate, overall survival, safety	—

Countries

Japan

Contacts

Public ContactJun Ninomiya

Sairtama Breast Cancer Clinical Study Group (SBCCSG) Secretariat Division (Ninomiya hospital)

jninomiya@grape.plala.or.jp048-941-2223

Outcome results

None listed

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