Salvage Therapy With Bevacizumab Plus Docetaxel and Cisplatin for Taiwanese Metastatic Breast Cancer

Sponsor
Taipei Medical University Hospital
Study ID
NCT01025349
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab, docetaxel, cisplatin — DRUG
    Bevacizumab 8 mg/kg(over 60 minutes) on first day of first cycle, followed by 5 mg/kg on first day of the rest cycles, repeat every 2 weeks. docetaxel 45 mg/m2(over 60 minutes) on day 1 of each cycle, repeat every 2 weeks. cisplatin 50 mg/m2(over 4 hours) on day 1 of each cycle, repeat every 2 weeks.

Study Details

Bevacizumab is a monoclonal antibody currently used for the treatment of colorectal cancer. It works by preventing the formation of new blood vessels (angiogenesis). The drug has been shown to inhibit vascular endothelial growth factor (VEGF) activity. Previous research showed positive findings in other solid tumors that had metastasized. In this study, the investigators are investigating the response of adding bevacizumab to conventional chemotherapy for metastatic breast cancer patients.

Key Dates

First listed
Dec 3, 2009
Start date
Jan 31, 2005
Status verified
Dec 2009
Primary completion
Sep 30, 2009
Completion
Sep 30, 2009

Study Design

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

Arms

  • Experimental: metastatic breast cancer
    Patients with histological or cytological proven metastatic breast cancer were recruited. The previous hormonal therapy for metastatic breast cancer or cytotoxic therapy was allowed. The Her2/Neu over-expressive status should be negative. Patients with brain metastasis are excluded.

Primary Outcome Measure

Response Rate [ Time Frame: every 3 months ]

Related Studies