A study of eribulin in combination with trastuzumab and pertuzumab for advanced or recurrent human epidermal growth factor receptor 2 (HER2)-positive breast cancer
- Conditions
- First or second line therapy for advanced or recurrent HER2-positive breast cancer patients who have received taxane and trasutuzumab as adjuvant or recurrent therapy.
- Registration Number
- JPRN-UMIN000012232
- Lead Sponsor
- JBCRG(Japan Breast Cancer Research Group)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- Female
- Target Recruitment
- 46
Not provided
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.Iinterstitial pneumonia or pulmonary fibrosis by chest X-ray 5.Large pleural effusion or ascites requiring repeat drainage 6.Concurrent uncontrolled hypertension or diabetes mellitus 7.Systemic administration of steroid drug 8.Pregnant females or females of child-bearing potential 9.Concurrent active other malignancy 10.Metachronous or spontaneous bilateral breast cancer except ductal carcinoma in situ 11.Clinically important mental disorder or history of central nervous system damage 12.Clinically significant central nervous system metastases 13.Concurrent enrollment of other clinical trial 14.History use of eribulin 15.Reccurence in conserving breast or local recurrence that is appropriate therapy to reoperate 16.HBs antigen positive 17.Not suitable for participation with any other reasons (including rapid progression disease, life threatening status if not successfully treated)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival(PFS)
- Secondary Outcome Measures
Name Time Method Response rate(RR),Safety,Overall survival(OS),Efficacy after prior use of pertuzumab,Compliance of eribulin, Efficacy of later therapy