Bevacizumab With Etoposide and Cisplatin in Breast Cancer Patients With Brain and/or Leptomeningeal Metastasis

Sponsor
National Taiwan University Hospital
Study ID
NCT01281696
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab, etoposide, cisplatin — DRUG
    Bevacizumab (15mg/kg) on D1, etoposide (70mg/m2) on D2-D4, cisplatin (70mg/m2) on D2; 21 days a cycle, for a maximum of 6 cycles
  • Intrathecal methotrexate — DRUG
    Additional intrathecal methotrexate only given in patients with leptomeningeal metastasis

Study Details

The main purpose of this study is to investigate the efficacy of bevacizumab, etoposide and cisplatin in treating breast cancer patients with central nervous system metastasis (including brain parenchymal and leptomeningeal metastasis).

Key Dates

First listed
Jan 24, 2011
Start date
Jan 31, 2011
Status verified
Oct 2013
Primary completion
Jul 31, 2013
Completion
Oct 31, 2013

Study Design

Enrollment
40 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Bevacizumab, etoposide, cisplatin (BEEP)

Primary Outcome Measure

Response rate of central nervous system (CNS) metastasis [ Time Frame: 1 year ]

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