Status:
COMPLETED
Gemcitabine Plus Bevacizumab in Locally Recurrent or Metastatic Breast Cancer
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Metastatic Breast Cancer
Locally Advanced Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
To determine how long Gemcitabine and Bevacizumab will stop the cancer from growing in patients with advanced breast cancer.
Eligibility Criteria
Inclusion
- Must be female and greater than or equal to 18 yrs of age
- Participants must have confirmed cancer with measurable or evaluable, locally recurrent or metastatic disease.
- Participants must have received a taxane as neo-adjuvant and/or adjuvant therapy
- Participants may have received prior hormone therapy for locally recurrent or metastatic disease
Exclusion
- Participants with breast cancer overexpressing Human Epidermal growth factor Receptor 2 (HER2) gene amplification
- Prior chemotherapy or targeted therapy for metastatic breast cancer
- Prior treatment with gemcitabine, trastuzumab, lapatinib or bevacizumab in any setting
- History of, or active brain mets
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to treatment, or anticipation of need for major surgical procedure during course of study
- Prior history of high blood pressure crisis
- Have a serious, nonhealing wound, ulcer, or bone fracture
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00623233
Start Date
March 1 2008
End Date
January 1 2011
Last Update
January 9 2012
Active Locations (16)
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1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Fayetteville, Arkansas, United States, 72703
2
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Fresno, California, United States, 93720
3
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
San Diego, California, United States, 92121
4
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Longmont, Colorado, United States, 80501