Addition of Vismodegib to Neoadjuvant Chemotherapy in Triple Negative Breast Cancer Patients
Status:
Unknown status
Trial end date:
2018-12-01
Target enrollment:
Participant gender:
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
Phase:
Phase 2
Details
Lead Sponsor:
Clinica Universidad de Navarra, Universidad de Navarra