JPRN-UMIN000018383已完成1 期
A Phase Ib study of Trastuzumab emtansine plus S-1 or Capecitabine in patients with previously trastuzumab treated metastatic breast cancer - A Phase Ib study of Trastuzumab emtansine plus S-1 or Capecitabine in patients with previously trastuzumab treated metastatic breast cancer(MARIA15-01)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 ot applicable（—）
- 性别
- Female
入选标准
- 未提供
排除标准
- •1. Prior treatment with chemotherapy (including trastuzumab, T-DM1), hormone therapy, immune therapy or biologics with in 14 days prior to entry. 2. Invasive surgery within 28 days prior to enrollment. 3. Documented history of congestive heart failure of any New York Herat Association (NYHA) class II-IV, or >= grade 3 heart failure per CTCAE v4.0 4. Diagnosis as angina pectoris requiring treatment within 6 months prior entry. 5. Uncontrollable hypertension (not controlled by medication systolic blood pressure <150 mmHg and diastolic blood pressure <100 mmHg) 6. Baseline LVEF <50% 7. History of exposure to cumulative doses of anthracyclines (e.g. Doxorubicin>500mg/m2, Epirubicin>720 mg/m2). 8. History of >=Grade3 infusion reaction caused by Trastuzmab or T-DM1. 9. History of discontinue trastuzumab or T-DM1 reason for adverse event. 10. Not tolerable to S-1 or Capecitabine in prior therapy 11. History of intolerance to Trastuzumab added substance (e.g. sodium succinate, sucrose, polusorbate). 12. Patients who needs continuous administration of flucytosine, phenytoin, or warfarin potassium. 13. Patients have symptomatic or periodical medication for brain metastasis 14. >=grade 2 peripheral neuropathy. 15. Hyper sensitivity to fuluoropyrimidine or known dihydropyrimidine dehydrogenase (DPD) deficiency. 16. Current known viral hepatitis. 17. Active carcinoma affect to prognosis. 18. Congenial hemorrhage or clotting abnormality 19. Current serious, uncontrolled infection or current known HIV infection. 20. Any patient unwilling or unable to use adequate contraceptive measures during study treatment and for 7 months after the last dose of study treatment. 21. Any other condition, which in the opinion of the investigator or sub-investigator would preclude participation in the study
研究者
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