Trial Information
A Phase Ⅱ Study of an All-Oral Combination of Low-dose Etoposide/Capecitabine in Patients With Metastatic Breast Cancer Previously Treated With Anthracyclines and/or Taxanes
Inclusion Criteria:
- female patients between 18 and 65 years old
- patients with metastatic breast cancer previousely treated with A/T
- able and willing to give consent to participate in the study
Exclusion Criteria:
- pregnant or lactating females
- other tumor history
- instable complication (e.g., myocardial infarction within 6 months,arrhythmia,
unstable diabetes, hypercalcemia) or uncontrolled infection
- concurrent disease or condition that would make the patient inappropriate for study
participation
- resist to participate in the study
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Clinical benefit rate
Outcome Description:
Clinical benefit is defined as CR, PR, SD≥24 weeks.
Outcome Time Frame:
24 weeks after the treatment
Safety Issue:
No
Principal Investigator
Yan Wei, Doctor
Investigator Role:
Study Chair
Investigator Affiliation:
Peking University Cancer Hospital & Institute
Authority:
China: Food and Drug Administration
Study ID:
BCP09
NCT ID:
NCT01589159
Start Date:
January 2013
Completion Date:
January 2015
Related Keywords:
- Metastatic Breast Cancer
- Breast Neoplasms