A Phase Ib study of Trastuzumab emtansine plus S-1 or Capecitabine in patients with previously trastuzumab treated metastatic breast cancer
- Conditions
- Patients with HER2-positive metastatic breast cancer that has progressed on trastuzumab
- Registration Number
- JPRN-UMIN000018383
- Lead Sponsor
- St Marianna University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 20
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of dose limiting toxicity in each dose level at completion of first cycle
- Secondary Outcome Measures
Name Time Method Incidence of adverse events Response rate (RR)