A Phase II Multi-center, Open-label, Neoadjuvant, Randomized Study of Weekly Paclitaxel With or Without LCL161 in Patients With Triple Negative Breast Cancer
To assess whether adding LCL161 to weekly paclitaxel enhances the efficacy of paclitaxel in women with triple negative breast cancer whose tumors are positive for a defined pattern of gene expression
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : LCL161
- drug : paclitaxel
Phase: Phase 2
Ages Eligible For Study:
- Histologically confirmed diagnosis of invasive triple negative breast cancer - Known status for the LCL161 predictive gene expression signature as determined during molecular pre-screening - Candidates for mastectomy or breast-conserving surgery - Primary tumor of greater than 20 mm and less than or equal to 50 mm diameter measured by imaging (previous Amendment #3 was tumor size greater than 10 mm) - Regional nodes N0-N2 - Absence of distant metastatic disease - ECOG performance status 0-1 - Adequate bone marrow function - Adequate liver function and serum transaminases - Adequate renal function