drugset / Trial / NCT01501669
Irinotecan/Capecitabine Versus Capecitabine in Patients Treated With A/T for HER2 Negative Metastatic Breast Cancer
Phase 3
Unknown
222 enrolled
National Cancer Center, Korea
Asan Medical Center · collabChung-Ang University · collabInha University Hospital · collabKorea University Anam Hospital · collabSamsung Medical Center · collabSeoul National University Bundang Hospital · collabSeoul National University Hospital · collabSeverance Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is a multicenter, randomized study, open-label, phase III study.The efficacy of irinotecan and capecitabine combination will be superior to capecitabine alone in term of progression free survival in metastatic breast cancer patients previously treated with anthracycline and taxane.
Timeline
- Start
- 2011-06
- Primary completion
- 2014-02
- Completion
- 2014-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 1000 mg/m2 | — |
| Subject | Capecitabine | Small molecule | 1250 mg/m2 | — |
| Subject | Irinotecan | Small molecule | 80 mg/m2 | — |