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 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.

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Key information

Conditions

Metastatic Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Peking University Cancer Hospital & Institute

Beijing, Beijing Municipality, 100142, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Capecitabine

Drug

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

etoposide

Drug

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

Primary outcomes

Clinical benefit rate

Time frame: 24 weeks after the treatment

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

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Sponsors and collaborators

Lead sponsor

Tao OUYANG

Other

Registry information

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2016
First posted: May 1, 2012
Registry last updated: Feb 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed