Abraxane With or Without Tigatuzumab in Patients With Metastatic, Triple Negative Breast Cancer
Status:
Completed
Trial end date:
2017-06-01
Target enrollment:
Participant gender:
Summary
Breast cancer is the most commonly diagnosed cancer and the second leading cause of cancer
deaths in American women. Metastatic disease including metastatic breast cancer unfortunately
remains incurable. One reason is due to the inability to develop specific therapies for
specific cancer subsets.
The use of modern genomic techniques has significantly enhanced our recent understanding of
breast cancer biology. Five distinct breast cancer subsets have been recognized, one of which
is basal-like breast cancer. Basal-like breast cancer is typically estrogen receptor (ER)
negative, progesterone receptor (PR) negative and human epidermal growth factor receptor 2
(HER-2-Neu) negative. This is referred to as triple negative breast cancer or TBNC. TBNC
represents a significant proportion of breast cancer patients (10-20%) and has a poor
prognosis with no targeted approach to therapy as of yet.
Tigatuzumab is a humanized monoclonal antibody targeting a death receptor on the breast
cancer cells. Previous studies have shown that combining antibodies with selected
chemotherapy agents have induced tumor cell death. The hypothesis of this study is to use
tigatuzumab and combine it with Abraxane to serve as a targeting agent in metastatic TBNC
patients.
Phase:
Phase 2
Details
Lead Sponsor:
University of Alabama at Birmingham
Collaborators:
Daiichi Sankyo UK Ltd. Susan G. Komen Breast Cancer Foundation Triple Negative Breast Cancer Foundation