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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


Phase 2
18 Years
80 Years
Open (Enrolling)
Female
Metastatic Breast Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical benefit rate

Outcome Description:

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

Outcome Time Frame:

24 weeks after the treatment

Safety Issue:

No

Principal Investigator

Yan Wei, Doctor

Investigator Role:

Study Chair

Investigator Affiliation:

Peking University Cancer Hospital & Institute

Authority:

China: Food and Drug Administration

Study ID:

BCP09

NCT ID:

NCT01589159

Start Date:

January 2013

Completion Date:

January 2015

Related Keywords:

  • Metastatic Breast Cancer
  • Breast Neoplasms

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