Immunological response and safety of autologous dendritic cells in triple-negative breast cancer (TNBC) patients who have received curative surgery after neoadjuvant chemotherapy(NCT).
- Conditions
- Neoplasms
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
? Males or females aged 20 years or older (mostly females)
? Patients who have been diagnosed histologically with non-metastatic stage II–III invasive ductal cancer; confirmed to be ER(-), PR(-), HER2 (-) and HER2 (1+), HER2(2+) using FISH(-); and completed surgery and radiotherapy within the last 3–6 months after neoadjuvant chemotherapy
(? Patients requiring adjuvant radiotherapy were all patients who underwent breast-conserving surgery or who underwent complete resection for stage N1 or higher cancer at the time of diagnosis)
<Neoadjuvant chemotherapy>
1. AC therapy followed by docetaxel therapy
* AC therapy: 4 doses of doxorubicin + cyclophosphamide
* Docetaxel therapy: 4 doses of docetaxel
2. AC therapy followed by paclitaxel therapy
* AC therapy: 4 doses of doxorubicin + cyclophosphamide
* Paclitaxel therapy: 4 doses of paclitaxel 175 mg/m2 or 12 doses of paclitaxel 80 mg/m2
? Patients with an autologous (frozen) tumor tissue sample for breast cancer
? Patients with an ECOG score of 0–2 for performance status
? Patients satisfying the following conditions:
- Hematologic function: WBC count =3,000/µL, ANC =1,500/µL,
- Platelet count =75,000/µL, hemoglobin =9.0 mg/dL
- Hepatic function: bilirubin =1.5-fold the normal values, ALT and AST =2.5-fold the normal values
- Renal function: creatinine =1.5 mg/dL
? Among fertile patients, those who consent to the appropriate contraception
? Among female patients who may be pregnant, those patients with a negative result in urine HCG testing 7 days before registration
? Individuals who sign the consent form and are able to consent to the clinical trial and follow-up procedures
? Patients contraindicated for or requiring caution when taking cyclophosphamide
- Patients being administered pentostatin; patients with a history of infectious disease, severe bone marrow depression, cystitis, urinary tract obstruction, or hypersensitivity to the drug’s ingredient; pregnant or breastfeeding women; and patients with severe liver or kidney dysfunction
- Patients with varicella
? Patients who have received other types of immunotherapy in the last year
?Patients for whom the planned dose of test drug cannot be prepared because of difficulty obtaining a sufficient amount of autologous tumor tissue
?Patients with uncontrolled autoimmune disease or severe internal disease (severe infection, heart disease, etc.)
?Patients with uncontrolled central nervous system or psychiatric disability
?Patients who have been diagnosed with multiple active primary cancer in the last 5 years, excluding properly treated cervical carcinoma in situ, basal or squamous cell carcinoma of the skin, and thyroid cancer
? HIV-positive patients
? Patients who have been treated for tuberculosis within the last year
? Pregnant or breastfeeding women
? Patients who are regularly administered corticosteroids (or equivalent; excluding medication for acute hypersensitivity reaction, or patients being administered a low dose (=20 mg methylprednisolone or equivalent) for at least 6 months before being administered the test drug in this study)
? Patients who have been judged to be unsuitable as a clinical trial participant by another researcher
- Patients who were certain to drop out of the study or who were unavailable for long-term follow-up for any of the following reasons: psychological, social, family, or geographical reasons, or difficulty adhering to the proper follow-up procedures or the clinical study plan
- Patients with uncontrolled hepatitis, chronic liver disease, or diabetes
- Patients who were considered to be unsuited to participating in this trial by their attending physician
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluates the safety
- Secondary Outcome Measures
Name Time Method Examine the immun respnese.;Analyze survival (3yrs-disease free survial, overall survival)