Phase I/II Trial of Sorafenib Plus Ixabepilone in HER2-Negative Metastatic Breast Cancer
Status:
Completed
Trial end date:
2014-08-01
Target enrollment:
Participant gender:
Summary
In this study, patients with metastatic HER2-negative breast cancer will receive treatment
with ixabepilone and sorafenib until disease progression or unacceptable toxicity occurs. The
Phase I portion of this study will determine the maximum tolerated doses (MTDs) of sorafenib
and ixabepilone that may be used in combination for first- or second-line treatment of MBC.
The MTDs identified in the Phase I portion of the study will be used in the Phase II portion
which will evaluate the efficacy and safety of the combination of sorafenib and ixabepilone
in patients who have received at least one prior chemotherapy treatment in either the
adjuvant or neoadjuvant setting or following one prior MBC chemotherapy in MBC patients who
had not received prior adjuvant or neoadjuvant breast cancer chemotherapy. This will be one
of the initial trials investigating the use of this treatment combination for MBC.
This trial will be conducted under the leadership of the Sarah Cannon Research Institute
(SCRI) Oncology Research Consortium, a community-based, multi-center, clinical trial
organization.