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Clinical Trial Summary

A phase II study of irinotecan in 3 line or more therapy in local recurrence or metastatic breast cancer. Evaluate the effect and safety of irinotecan in local recurrence or Metastatic breast cancer patients who recieved anthracycline or taxane drugs. The primary endpoint is Disease Control Rate and Progression free survival. The second endpoint is 3 or 4 grade Adverse Events 、overall survival.All the patients will recieve this therapy till disease progress or other occurrence of withdrawal standards.


Clinical Trial Description

A phase II study of irinotecan in 3 line or more therapy in local recurrence or metastatic breast cancer. Evaluate the effect and safety of irinotecan in local recurrence or Metastatic breast cancer patients who recieved anthracycline or taxane drugs. The primary endpoint is Disease Control Rate and Progression free survival. The second endpoint is 3 or 4 grade Adverse Events 、overall survival. irinotecan 100mg/m2,iv,day1,day8,every 3cycles.If no AE happens, increase irinotecan dose to125mg/m2 at the second cycle.All the patients will recieve this therapy till disease progress or other occurrence of withdrawal standards. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02030678
Study type Interventional
Source Liaoning Tumor Hospital & Institute
Contact Tao Sun, Doctor
Email jianong@126.com
Status Recruiting
Phase Phase 2
Start date September 2014
Completion date December 2020

See also
  Status Clinical Trial Phase
Recruiting NCT02188693 - Gemcitabine as a Single Agent in the Maintenance Chemotherapy of Patients With Metastatic Breast Cancer N/A
Completed NCT00226928 - Psychosocial Treatment for Improving Chances of Survival in Women With Breast Cancer N/A