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

Metastatic Breast Cancer Clinical Trial

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 Trial Details — Status: Completed

Administrative data

• NCT number: NCT01589159
• Other study ID #: BCP09
• Status: Completed
• Phase: Phase 2
• First received: April 28, 2012
• Last updated: February 24, 2017
• Start date: January 2013
• Est. completion date: December 2016

Study information

• Verified date: February 2017
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• Capecitabine
Drug:capecitabine 700mg/m2, twice daily on days 1-14.
• Etoposide
Etoposide 30mg/m2, once daily on days 1-7.

Locations

Country	Name	City	State
China	Peking University Cancer Hospital & Institute	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Tao OUYANG

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical benefit rate	Clinical benefit is defined as CR, PR, SD=24 weeks.	24 weeks after the treatment