A Phase I study of intratumoral administration of TDM-812 in patients with treatment-resistant breast cancer (RPN2siRNA)
- Conditions
- treatment-resistant breast cancer
- Registration Number
- JPRN-UMIN000016790
- Lead Sponsor
- ational Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 30
Not provided
1. Patients who meet the following conditions. a)Patients who received other investigational drug(s) within 4 weeks before enrollment b)Patients who received systemic therapy within 3 weeks before enrollment c)Patients who received surgery within 4 weeks before enrollment d)Patients who received radiation in wide area within 4 weeks before enrollment or received palliative radiation within 2 weeks before enrollment e)Patients who have received radiation to planned lesion of administration of investigational drug 2. Patients with brain metastasis, except for patients who have completed topical therapy and stopped treatment with glucocorticoid agents at least 4 weeks before enrollment. For these patients, stable disease must be confirmed by symptoms and the images at the time of enrollment compared to the one obtained at least 4 weeks before enrollment.. 3. Patients with systemic active infection. 4. Patients with active infection at planned lesions of administration of investigational drug. 5. Patients with allergy to local anesthetic 6. Patients with respiratory failure requiring oxygen inhalation therapy 7. Patients requiring anti-coagulant therapy 8. Patients with serious cardiovascular disease (congestive cardiac failure within 6 months before enrollment, history of unstable angina or myocardial infarction, or serious arrhythmia) 9. Patients with difficulty following the study procedures due to psychiatric disease or psychological symptoms 10. Patients who meet the following conditions. a)HBs-Ag positive (In case HBs-Ag is negative but HBs-Ab and/or HBc-Ab are/is positive, only HBV-DNA negative can be allowed to enroll.) b)HCV-Ab positive and/or HCV-RNA positive c)HIV-Ab positive 11. Pregnant or breast-feeding women, or women of child bearing potential who intend to become pregnant 12. Patients who should not participate in the study, as judged by the investigator(s)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety and tolerability
- Secondary Outcome Measures
Name Time Method ratio of adverse events, local response rate (RECIST1.1)