None listed
Conditions
Interventions
Drug : Dendritic Cell Inj. : - Dose: 1.2×107 cells, - Time : D0, D14, D28, D56, D84, - Route: Intra dermal,
cyclophosphamide : -Dose : 50mg, twice/day, 1week on and 1week off - Time: 7 cycle(-D7~-D1 ,
Sponsors
Dongnam Institute of Radiological & Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ?Men and women over 20 years old (mainly women) ?Histologically, in the case of invasive ductal cancer, ER(-), PR(-), HER2(-) or HER2 (1+), HER2(2+), clinical stage ?~? without metastatic lesions is diagnosed by FISH(?). Patients diagnosed within 3 to 6 months of completing prior anticancer therapy and completing surgery and radiation therapy (?Patients who require radiation therapy as adjuvant therapy include all patients who underwent breast-conserving surgery and patients who underwent total resection at clinical stage N1 or higher at the time of diagnosis) 1. Docetaxel therapy after AC therapy -AC : Doxorubicin + Cyclophosphamide 4cycle - Docetaxel : Docetaxel 4cycle 2. AC after Paclitaxel - AC : Doxorubicin + Cyclophosphamide 4cycle - Paclitaxel : 175mg/m2 4cycle or Paclitaxel 80mg/m2 12cycle ?Patients with autologous (frozen) tumor tissue for breast cancer ? ECOG scale 0-2 ?Patients who satisfy the following - - Hematologic function: WBC count 3,000/=, ANC 1,500/=, - Platelet count 75,000/=, hemoglobin 9.0mg/= - Hepatic function: bilirubin normal lange X1.5 =, ALT AST normal lange X2.5 = - Renal function: creatinine 1.5mg/dL = ? Among all patients capable of reproduction, those who agree to use appropriate contraception ? For women of childbearing potential, patients with a negative urine HCG test 7 days prior to test registration ? A person who can sign the informed consent form and agree to the clinical trial and follow-up procedures
Exclusion criteria
Exclusion criteria: ?Patients with contraindications and cautious administration of cyclophosphamide - Pentostatin recipients, infections, severe bone marrow suppression, cystitis, urinary outflow obstruction, those with a history of hypersensitivity to the ingredients of this drug, pregnant women, lactating women, severe liver and kidney disorders. - Patients with chickenpox. ?Patients who have received other immunotherapy within the past year. ?When it is impossible to manufacture a test drug at the intended dosage due to difficulty in obtaining sufficient autologous tumor tissue. ?Patients with uncontrolled autoimmune disease or uncontrolled serious medical disease (severe infection, heart disease, etc.) ?Patients with uncontrolled central nervous system or mental disorders. ?Patients within 5 years of being diagnosed with appropriately treated cervical carcinoma in situ, basal or squamous cell carcinoma of the skin, or active overlapping cancer, excluding thyroid cancer. ?HIV Positive. ?Patients who received tuberculosis treatment within the past year ?pregnant and lactating women ?When corticosteroids (or equivalent drugs) are administered on a regular basis (however, when administered to treat acute hypersensitivity reactions, or when administered at low doses (methylprednisolone 20 mg or less or equivalent drugs) more than 6 months prior to administration of this study drug) is allowed) ?Patients judged by other researchers to be unsuitable as clinical trial subjects -Patients who are certain to drop out of the clinical trial or who cannot be followed up regularly for the following reasons. For example, psychological, social, family or geographical reasons, or conditions that make it difficult to properly follow-up or comply with the clinical trial plan. -Poorly controlled hepatitis and chronic liver disease or diabetes. -Additionally, patients judged by the attending physician to be unsuitable for this treatment trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diseade-free survival rate, Survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Immune response | — |
Countries
Korea, Republic of
Contacts
Public ContactMi young Kim
Dongnam Institute of Radiological & Medical Sciences
Outcome results
None listed