Phase II study of eribulin with trasutuzumab for pretreated locally advanced / metastatic HER2-positive breast cancer
- Conditions
- locally advanced / metastatic HER2-positive breast cancer
- Registration Number
- JPRN-UMIN000012350
- Lead Sponsor
- agoya University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- 50
Not provided
(1)Patients with active double cancer with less than 5years desease free intervals except for dissected carcinoma in situ or intramucosal cancer. (2)Patients with a past history of interstitial pneumonitis, pulmonary fibrosis or severe emphysema. (3)Patients diagnosed as having unstable angina, congestive heart failure, myocardial infarction, ventricular arrhythmia requiring medication within 6 months before registration. (4)Patients with uncontrolled complications(malignant hypertension,infection,hemorrhagic tendency,diabates) (5)Active infection or fever suspicious of infection (6)Severe renal dysfunction and liver dysfunction (jaundice) (7)History use of eribulin (8)Patients with uncontrollable brain metastases (9)HBs antigen positive (case of the anti-HBs or anti-HBc positive patients in HBs antigen negative, for adding precision inspection and administration of nucleic acid analog, do at the discretion of each facility) (10)Patients who were considered by the primary care physician to be inappropriate as subjects of this trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method objective response rate
- Secondary Outcome Measures
Name Time Method