drugset / Trial / NCT00957125

A Translational Trial on Molecular Markers and Functional Imaging to Predict Response of Preoperative Treatment of Breast Cancer Early

NCT00957125 ↗

Phase 2 Unknown 151 enrolled Thomas Hatschek
NaSingle-groupOpen-labelTreatment

Summary

Patients with localized primary breast cancer including inflammatory breast cancer suitable for primary medical treatment and/or regional lymph node metastases receive six cycles of chemotherapy with epirubicin and docetaxel. Treatment evaluations are performed after the second, fourth and sixth cycle. In case of SD/PR after the second course, bevacizumab is added to the combination for the remaining four courses. Besides standard response evaluation clinically and by mammography and ultrasound, several functional imaging techniques including MR, CT-PET and contrast-enhanced ultrasound are investigated. Fresh tumor tissue samples from the primary tumor are collected before start, after two courses and in connection with surgery. The aim of the trial is to detect biological factors and functional imaging techniques with the ability to predict response at an early stage of treatment.

Timeline

Start
2008-09
Primary completion
2011-11
Completion
2016-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 15 mg/kg Intravenous
Subject Docetaxel Small molecule 75 mg/m2 Intravenous
Subject Epirubicin Small molecule 75 mg/m2 Intravenous

Indications