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

Tao OUYANG

Status and phase: Completed; Phase 2

Conditions: Metastatic Breast Cancer

Treatments: Drug: Capecitabine; Drug: Etoposide

Study type: Interventional

Funder types: Other

Identifiers

NCT01589159

BCP09

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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54 participants in 1 patient group

Experimental

Experimental group

Treatment:

Drug: Etoposide

Drug: Capecitabine