We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01589159
First Posted: May 1, 2012
Last Update Posted: February 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Tao OUYANG, Peking University
April 28, 2012
May 1, 2012
February 27, 2017
January 2013
July 2016   (Final data collection date for primary outcome measure)
Clinical benefit rate [ Time Frame: 24 weeks after the treatment ]
Clinical benefit is defined as CR, PR, SD≥24 weeks.
Clinical benefit rate
Clinical benefit is defined as CR, PR, SD≥24 weeks.
Complete list of historical versions of study NCT01589159 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Intervention Model: Single Group Assignment
Masking: None (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.
 
Completed
54
December 2016
July 2016   (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
Sexes Eligible for Study: Female
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01589159
BCP09
Yes
Not Provided
Not Provided
Tao OUYANG, Peking University
Tao OUYANG
Not Provided
Study Chair: Yan Wei, Doctor Peking University Cancer Hospital & Institute
Peking University
February 2017

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