NCT02694224

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

A Randomized Phase II Pilot Study to Evaluate Safety and Efficacy of the Addition of Vismodegib to Standard Neoadjuvant Chemotherapy in Triple Negative Breast Cancer Patients

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	vismodegib	Smo inhibitor
DRUG	Paclitaxel	Paclitaxel (80 mg/m2) weekly x 12 doses followed by sequential dose dense Epirubicin (90 mg/m2) plus Cyclophosphamide (600 mg/m2) each 2 weeks x 4 doses with granulocyte macrophage colony stimulating factors (GM-CSF) support
DRUG	Epirubicin	dose dense Epirubicin (90 mg/m2) plus Cyclophosphamide each 2 weeks x 4 doses with GMCSF after Paclitaxel
DRUG	Cyclophosphamide	dose dense Cyclophosphamide (600 mg/m2) together with Epirubicin each 2 weeks x 4 doses with GMCSF after Paclitaxel

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-12-01
• Completion: 2018-12-01
• First posted: 2016-02-29
• Last updated: 2017-10-24

Locations

1 site across 1 country: Spain