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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

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
  Purpose
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.

Condition Intervention Phase
Metastatic Breast Cancer Drug: Capecitabine Drug: Etoposide Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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

Resource links provided by NLM:


Further study details as provided by Tao OUYANG, Peking University:

Primary Outcome Measures:
  • Clinical benefit rate [ Time Frame: 24 weeks after the treatment ]
    Clinical benefit is defined as CR, PR, SD≥24 weeks.


Enrollment: 54
Actual Study Start Date: January 2013
Study Completion Date: December 2016
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental Drug: Capecitabine
Drug:capecitabine 700mg/m2, twice daily on days 1-14.
Drug: Etoposide
Etoposide 30mg/m2, once daily on days 1-7.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01589159


Locations
China, Beijing
Peking University Cancer Hospital & Institute
Beijing, Beijing, China, 100142
Sponsors and Collaborators
Tao OUYANG
Investigators
Study Chair: Yan Wei, Doctor Peking University Cancer Hospital & Institute
  More Information

Responsible Party: Tao OUYANG, Chairman of Breast Center, Peking University
ClinicalTrials.gov Identifier: NCT01589159     History of Changes
Other Study ID Numbers: BCP09
First Submitted: April 28, 2012
First Posted: May 1, 2012
Last Update Posted: February 27, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Etoposide phosphate
Taxane
Etoposide
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors