Metastatic Breast Cancer Clinical Trial
Official title:
Phase I/II Trial of Sorafenib Plus Ixabepilone in HER2-Negative Metastatic Breast Cancer (MBC)
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.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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