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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01589159

Enrollment

Registered

2012-05-01

Start date

2013-01-31

Completion date

2016-12-31

Last updated

2017-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Breast Cancer

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.

Interventions

DRUGCapecitabine

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

DRUGEtoposide

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Clinical benefit rate	24 weeks after the treatment	Clinical benefit is defined as CR, PR, SD≥24 weeks.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026