KCT0004573进行中（未招募）未知
Randomized phase II trial of pemetrexed plus vinorelbine versus vinorelbine in patients with recurrent or metastatic breast cancer previously treated with or resistant to anthracycline and taxane
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 125
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
- •1. Recurrent breast cancer or metastatic (stage 4) breast cancer that is histologically confirmed without resection or radiotherapy
- •2. HER2 negative breast cancer.
- •3. ECOG Performance 0-2
- •4. Age = 20 years
- •5. Anthracycline (unless medically inappropriate or contraindicated), prior treatment with taxane
- •6. All previous chemotherapy should have been completed 3 weeks prior to the start of treatment.
- •7. Hormonal therapy or radiotherapy (including conventional purposes) must have been completed two weeks prior to the start of treatment.
- •8. If there is a target lesion measurable by RECIST v1.1 or a non-measurable non-target lesion
- •9. Hematologic function: Absolute neutrophil =1,500 / mm3, platelet =100,000 / mm3, hemoglobin = 9g / dL
- •10. Liver function: Total bilirubin = 1.5 x upper normal limit (UNL), alkaline phosphatase = 2.5 x upper limit, AST / ALT = 2 x upper limit (in case of liver metastases, AST / ALT = 2.5 x Normal upper limit, total bilirubin =3.0 mg / dL, alkaline phosphatase = 5 x normal upper limit, alkaline phosphatase = 5 x normal upper limit if multiple bone metastases are present)
- •11.Kidney function: Serum creatinine=1.5mg /dL
- •12. Willing and able to comply with the research protocol during the study.
- •13. A consent form must be obtained prior to enrollment in the study.
排除标准
- •1. History of more than 3 lines of anticancer drugs previously treated for metastatic breast cancer
- •-Excludes hormone monotherapy or combination therapy with hormones
- •-Included in cases of metastasis within 6 months of the end date of advanced chemotherapy and adjuvant chemotherapy
- •2. Pregnant or lactating women
- •3. History of Pemetrexed or Vinorelbine Previously
- •4. Current grade 2 or higher neuropathy
- •5. Symptomatic brain metastases
- •6. History of another malignant disease within the last five years (completely cured skin or squamous cell carcinoma, cured thyroid cancer and in-situ cervical cancer are acceptable).
- •7. Patients with hypersensitivity to the test drug or excipient component
- •8. Concurrent vaccination of yellow fever vaccine
研究者
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