A phase II study of eribulin in combination with trastuzumab and pertuzumab as First-Line therapy for metastatic HER2-positive breast cancer
- Conditions
- First-Line therapy for metastatic HER2-positive breast cancer.
- Registration Number
- JPRN-UMIN000021585
- Lead Sponsor
- Sairtama Breast Cancer Clinical Study Group (SBCCSG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- Female
- Target Recruitment
- 16
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.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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method time to chemotherapy treatment failure of response rate
- Secondary Outcome Measures
Name Time Method time to chemotherapy treatment failure, progression free survival, response rate, overall survival, safety