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.

Verified February 2013 by Peking University

Sponsor:

Information provided by (Responsible Party):

Tao OUYANG, Peking University

ClinicalTrials.gov Identifier:

NCT01589159

First received: April 28, 2012

Last updated: February 14, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

April 28, 2012

Last Updated Date

February 14, 2013

Start Date ^ICMJE

January 2013

Estimated Primary Completion Date

January 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Clinical benefit rate [ Designated as safety issue: No ]

Clinical benefit is defined as CR, PR, SD≥24 weeks.

Change History

Complete list of historical versions of study NCT01589159 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Metastatic Breast Cancer

Intervention ^ICMJE

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

Study Arm (s)

Experimental: Experimental

Interventions:

Drug: Capecitabine
Drug: Etoposide

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2015

Estimated Primary Completion Date

January 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Yan Wei, Doctor

0086-10-88196012

beizhongwy@163.com

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT01589159

Other Study ID Numbers ^ICMJE

BCP09

Has Data Monitoring Committee

Yes

Responsible Party

Tao OUYANG, Peking University

Study Sponsor ^ICMJE

Tao OUYANG

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Yan Wei, Doctor

Peking University Cancer Hospital & Institute

Information Provided By

Peking University

Verification Date

February 2013

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

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