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
This is a single-center, open-lable, non-comparative, prospective, phase Ⅱ efficacy and safety study. Eligible patients are enrolled in a single group. The investigators propose to determine the efficacy and safety of low-dose metronomic chemotherapy with Etoposide/Capecitabine in Patients with Metastatic Breast Cancer Previously Treated with Anthracyclines and/or Taxanes.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Clinical benefit rate [ Time Frame: 24 weeks after the treatment ] [ Designated as safety issue: No ]Clinical benefit is defined as CR, PR, SD≥24 weeks.
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
Drug:capecitabine 700mg/m2, twice daily on days 1-14.Drug: Etoposide
Etoposide 30mg/m2, once daily on days 1-7.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01589159
|Contact: Yan Wei, Doctoremail@example.com|
|Peking University Cancer Hospital & Institute||Recruiting|
|Beijing, Beijing, China, 100142|
|Contact: Yan Wei, Doctor 0086-10-88196012 firstname.lastname@example.org|
|Study Chair:||Yan Wei, Doctor||Peking University Cancer Hospital & Institute|