KCT0002931招募中未知
Immunological response and safety of autologous dendritic cells in triple-negative breast cancer (TNBC) patients who have received curative surgery after neoadjuvant chemotherapy(NCT).
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •? 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
排除标准
- •? 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
研究者
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