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

NCT01589159 | Completed Phase 2 DMC

• 1 other identifier: BCP09
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Clinical benefit rate

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

  24 weeks after the treatment

Study Arms (1)

Experimental

EXPERIMENTAL

Drug: Capecitabine; Drug: Etoposide

Interventions

Capecitabine DRUG

Drug:capecitabine 700mg/m2, twice daily on days 1-14.

Experimental

Etoposide DRUG

Etoposide 30mg/m2, once daily on days 1-7.

Experimental

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tao OUYANG: lead

Study Sites (1)

Peking University Cancer Hospital & Institute

Beijing, Beijing Municipality, 100142, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabine; Etoposide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Yan Wei, Doctor

  Peking University Cancer Hospital & Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chairman of Breast Center

Study Record Dates

• First Submitted: April 28, 2012
• First Posted: May 1, 2012
• Study Start: January 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 27, 2017

Record last verified: 2017-02

Locations

CN (1)