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

Seoul National University Hospital0 个研究点目标入组 125 人开始时间: 待定最近更新: 2020年1月14日

试验速览

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•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.

•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

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