Efficacy and safety of eribulin in combination with trastuzumab and pertuzumab for HER2-positive advanced breast cancer
- Conditions
- Eligible patients were those with HER2-positive advanced breast cancer who had previously received trastuzumab (HER) + pertuzumab (PER) + taxanes and T-DM1, followed by HER + PER + eribulin.
- Registration Number
- JPRN-UMIN000034477
- Lead Sponsor
- Keio University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- 35
Not provided
1 infection 2 severe allergy for medication 3 severe heart, renal, liver dysfunction 4 interstitial pneumonia or pulmonary fibrosis 5 large amount of pleural effusion or ascites 6 hypertension or diabetes that is poorly controlled 7 under steroid therapy 8 pregnant woman 9 who received transfusion, blood products, and hematopoietic factor products within 7 days 10 active double cancer (simultaneous double cancer and metachronous cancer within 5 years except for carcinoma in situ and intramucosal cancer) 11 history of psychiatric or CNS disorders which casts clinical problems 12 diagnosis or suspect of brain metastasis 13 engaging in other clinical trials 14 when responsible doctors made a judgement of inappropriate patient
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method overall response rate: ORR
- Secondary Outcome Measures
Name Time Method progression-free survival: PFS overall survival: OS adverse events