Status:
COMPLETED
Trastuzumab (Herceptin), Bevacizumab, and Docetaxel (Taxotere) Trial in Stage IV Metastatic Breast Cancer (MBC) Patients
Lead Sponsor:
Bhuvaneswari Ramaswamy
Collaborating Sponsors:
Genentech, Inc.
Case Comprehensive Cancer Center
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary objectives are to determine the progression-free survival (PFS) and to evaluate safety of the trastuzumab, bevacizumab and docetaxel regimen.
Detailed Description
Rationale: Antibodies are proteins that are normally part of the immune system that bind to foreign agents in the body. Researchers manufacture antibodies outside of the human body that bind to specif...
Eligibility Criteria
Inclusion
- Histologically confirmed breast cancer with evidence of metastatic disease
- HER2 3+ or FISH (fluorescent in situ hybridization)+
- Age ≥ 18 years
- No prior trastuzumab, except as given in the adjuvant or neoadjuvant setting.
- No prior chemotherapy in the metastatic setting.
Exclusion
- CNS (central nervous system) metastases
- Prior radiation therapy within the last 4 weeks
- Pregnant (positive pregnancy test) or lactating women
- Major surgical procedure, open biopsy, non-healing wounds, or significant traumatic injury within 28 days prior to starting study or anticipation of need for major surgical procedure during the study
- Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to start of study.
Key Trial Info
Start Date :
June 14 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 7 2017
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00428922
Start Date
June 14 2007
End Date
February 7 2017
Last Update
August 9 2018
Active Locations (3)
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1
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
2
Ohio State University
Columbus, Ohio, United States, 43210
3
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213