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Neoadjuvant Chemotherapy Including Sorafenib in Women With Previously Untreated Primary Breast Cancer

NCT00548899 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2015-03-09

No results posted yet for this study

Summary

The purpose of this study is to determine the efficacy and safety of sorafenib in the neoadjuvant setting in patients with primary breast cancer

Conditions

Interventions

DRUG

Nexavar (Sorafenib)

Tablet, Sorafenib follows a patient specific escalation scheme starting with 200 mg daily up to a maximum dose of 800 mg daily during EC chemotherapy on day 2-19. The achieved dose will be continued during paclitaxel chemotherapy during week 1-11 all day

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • GBG Forschungs GmbH

    lead OTHER

Principal Investigators

  • Sibylle Loibl, MD · GBG Forschungs GmbH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2011-09-30
Completion
2011-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT00548899 on ClinicalTrials.gov