Gemcitabine Plus Bevacizumab in Locally Recurrent or Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

To determine how long Gemcitabine and Bevacizumab will stop the cancer from growing in patients with advanced breast cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Collaborator: Genentech, Inc.
• Treatments: Bevacizumab; Gemcitabine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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