treatment-resistant breast cancer
Conditions
Interventions
TDM-812 is intratumorally administered weekly at each dose level.
Sponsors
National Cancer Center
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: [Disease characteristics] 1. Inoperable or relapse breast cancer 2. Histological confirmation of invasive breast cancer(e.g., invasive ductal carcinoma, and special types) 3. A treatment history of anthracycline (e.g., doxorubicin and epirubicin) and taxane (e.g., paclitaxel, docetaxel, and nab-paclitaxel) agents, irrespective of the type of combination or treatment order. [Patient characteristics] 1. Provision of signed informed consent. 2. Patients aged >=20 years women. 3. Eastern Cooperative Oncology Group Performance Status (PS) of 0 to 2. 4. Having at least one palpable lesion with which to evaluate objective response, based on the New RECIST guideline ver.1.1 5. Having lesions applicable to 4) which to be able to inject investigational drug 6. Having lesions applicable to 4) which to be able to conduct repeated biopsy 7. Patients with the following values in their latest laboratory tests, conducted within 7 days prior to the enrollment -Neutrophil count >=1,000/mm3 -Platelet count >=75,000/mm3 -Total bilirubin <=1.5 mg/dL*ULN -Serum ALT and AST <=100 U/dL (<=150 U/dL for patients with hepatic metastasis) -Serum creatinine <=1.2 mg/dL -ECG Normal or minimal changes not requiring treatment (ECG measurement may be performed within 28 days prior to the enrollment). 8. Recovery to grade <=1 from all toxicities related to chemotherapy and radiotherapy, except for stable grade <=2 sensory neuropathy and alopecia. 9. In case of fertile woman, Patients fulfilled the following condition a)not performed sex within 30 days before enrollment b)provision of consent to conduct effective contraception from study enrollment to 6 months after study discontinuation.
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety and tolerability | — |
Secondary
| Measure | Time frame |
|---|---|
| ratio of adverse events, local response rate (RECIST1.1) | — |
Countries
Japan
Contacts
Public ContactRitsuko Nagasaka
National Cancer Center Center for Research Administraion and Support Research Management Section
Outcome results
None listed