Addition of Vismodegib to Neoadjuvant Chemotherapy in Triple Negative Breast Cancer Patients

Summary

To evaluate safety and efficacy of vismodegib with standard neoadjuvant chemotherapy in breast cancer patients based on the CTCAE v4 2010 1. To study changes in biomarkers involved in the Hedgehog (HH) pathway in the first biopsy as compared to the later one 2. To detect predictive factors among patients who reached pathological complete response (pCR) as compared to those with no pCR 3. To evaluate the role of the addition of vismodegib in the pCR rate 4. To evaluate clinical responses by breast MRI and rates of breast conservative surgery after neoadjuvant chemotherapy 5. To evaluate QOL with EORTC QLQ-C30 scale

Timeline

Start

2016-04

Primary completion

2017-12

Completion

2018-12

Drugs

Indications