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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 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
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Peking University:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 54
Study Start Date: January 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (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

Ages Eligible for Study:   18 Years to 80 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01589159

Contacts
Contact: Yan Wei, Doctor 0086-10-88196012 beizhongwy@163.com

Locations
China, Beijing
Peking University Cancer Hospital & Institute Recruiting
Beijing, Beijing, China, 100142
Contact: Yan Wei, Doctor     0086-10-88196012     beizhongwy@163.com    
Sponsors and Collaborators
Tao OUYANG
Investigators
Study Chair: Yan Wei, Doctor Peking University Cancer Hospital & Institute
  More Information

No publications provided

Responsible Party: Tao OUYANG, Chairman of Breast Center, Peking University
ClinicalTrials.gov Identifier: NCT01589159     History of Changes
Other Study ID Numbers: BCP09
Study First Received: April 28, 2012
Last Updated: February 14, 2013
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Etoposide
Etoposide phosphate
Capecitabine
Fluorouracil
Antineoplastic Agents, Phytogenic
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013