Docetaxel, Capecitabine, and Bevacizumab in Treating Patients With Metastatic Breast Cancer

Sponsor
Alliance for Clinical Trials in Oncology
Study ID
NCT00088998
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab — BIOLOGICAL
  • capecitabine — DRUG
  • docetaxel — DRUG

Study Details

RATIONALE: Drugs used in chemotherapy, such as docetaxel and capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Bevacizumab may also stop the growth of tumor cells by stopping blood flow to the tumor. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving docetaxel and capecitabine together with bevacizumab works in treating patients with metastatic breast cancer.

Key Dates

First listed
Aug 5, 2004
Start date
Dec 31, 2004
Status verified
Dec 2016
Primary completion
Aug 31, 2006
Completion
Dec 31, 2010

Study Design

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

Arms

  • Experimental: docetaxel + bevacizumab + capecitabine
    Patients receive docetaxel IV over 1 hour and bevacizumab IV over 30-90 minutes on day 1. Patients also receive oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive at least 2 additional courses beyond CR. Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years.

Primary Outcome Measure

Confirmed tumor response (complete or partial) rate as measured by RECIST [ Time Frame: Up to 5 years ]

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