Investigator-Initiated Clinical Trials to assess the safety of SK-818 in patients with operable breast cancer
- Conditions
- Breast cancer
- Registration Number
- JPRN-UMIN000022494
- Lead Sponsor
- Kyushu University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 18
Not provided
1) Male 2) Multiple malignancies 3) Jaundice or cirrhosis 4) HBs antigen:positive (HBV testing for HBs antigen, HBs antibody and HBc antibody and HCV testing for HCV antibody should be performed within 3 months before operation) 5) Severe heart disease such as poorly controlled ischemic heart disease, heart failure and arrhythmia 6) Interstitial pneumonitis or pulmonary fibrosis 7) Blood disorders with disturbance of hematopoiesis such as Aplastic anemia or myelodysplastic syndromes 8) Active infection. 9) Severe drug allergy 10) Severe mental illness 11) Women during pregnancy or lactation and women who don't agree with contraception during the clinical trial 12) Participants in other clinical research within 30 days before giving informed consent 13) Patients as deemed appropriate for participation in this trial by medical doctors
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method