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 study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Peking University
Sponsor:
Information provided by (Responsible Party):
Tao OUYANG, Peking University
ClinicalTrials.gov Identifier:
NCT01589159
First received: April 28, 2012
Last updated: June 16, 2014
Last verified: June 2014

April 28, 2012
June 16, 2014
January 2013
January 2015   (final data collection date for primary outcome measure)
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.
Clinical benefit rate [ Designated as safety issue: No ]
Clinical benefit is defined as CR, PR, SD≥24 weeks.
Complete list of historical versions of study NCT01589159 on ClinicalTrials.gov Archive Site
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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
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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Breast Cancer
  • Drug: Capecitabine
    Drug:capecitabine 700mg/m2, twice daily on days 1-14.
  • Drug: Etoposide
    Etoposide 30mg/m2, once daily on days 1-7.
Experimental: Experimental
Interventions:
  • Drug: Capecitabine
  • Drug: Etoposide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
54
January 2015
January 2015   (final data collection date for primary outcome measure)

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
Female
18 Years to 80 Years
No
Contact: Yan Wei, Doctor 0086-10-88196012 beizhongwy@163.com
China
 
NCT01589159
BCP09
Yes
Tao OUYANG, Peking University
Tao OUYANG
Not Provided
Study Chair: Yan Wei, Doctor Peking University Cancer Hospital & Institute
Peking University
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP