Breast cancer
Conditions
Interventions
Continuous oral administration of SK-818 from 1 week before operation until 28 days after operation except on operation day
Sponsors
Kyushu University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Women between the age of 20 and 70 at giving informed consent 2) Histologically or cytologically proven invasive ductal breast cancer -Her2/ER/PgR: positive/negative -Synchronous/Heterochrony 3) Stage I ~ III 4) Curative surgery without breast reconstruction 5) eGFR> 30 6) Adequate liver function as follows: a. T-Bil: <=1.5x upper limit of normal (ULN) b. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT): >= 3.0x ULN 7) ECOG Performance Status PS 0-1 8) No neoadjuvant therapy for breast cancer 9) Oral administration 10) Written informed consent
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose limiting toxicity (DLT) | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events Pharmacokinetic for Propagermanium | — |
Countries
Japan
Contacts
Public ContactHisayo Morioka
EP-CRSU Japan Co. , Ltd Clinical Research Headquarters
Outcome results
None listed