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

NCT02694224 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-10-24

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Clinica Universidad de Navarra, Universidad de Navarra

    lead OTHER

Principal Investigators

  • Santisteban Marta, Doctor · Staff of the department of Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2017-12-31
Completion
2018-12-31

Countries

  • Spain

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02694224 on ClinicalTrials.gov