Phase II clinical trial of the combination of eribulin and trastuzumab for advanced/recurrent HER2-positive breast cancer: observational study
- Conditions
- breast cancer
- Registration Number
- JPRN-UMIN000028594
- Lead Sponsor
- Dept. of Endocrine & Breast Surgery, Kyoto Prefectural University of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 30
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 with brain metastases treatment is required at the time of registration. 4. Patients with serious co-morbidities (1)Uncontrolled diabates (2)Uncontrolled hypertension (3)Myocardial infarction within 24 weeks prior to registration, unstable angina, congestive heart failure, myocardial infarction or ventricular arrhythmia requiring medication. (4)Ischemic heart disease, arrhythmias, valvular disease requiring medication. (5)Liver dysfunction(jaundice) (6)Renal dysfunction (7)Active infection or fever suspicious of infection. (8)Other serious complications 5. Pregnant women, nursing mothers, women with possibility of pregnancy or women with no intention to contraception. 6. Other patients who were considered by the primary care physician to be inappropriate as subjects of this trial
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method