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Breast Cancer Study: Paclitaxel Versus Paclitaxel Plus Sorafenib in Second- or Third-line Treatment

NCT01320111 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2017-02-20

No results posted yet for this study

Summary

AIM OF STUDY

Primary Efficacy Variable:

The primary study objective is the proof of efficacy, measured by progression free survival (PFS) in the treatment of metastatic or locally inoperable recurrent breast cancer.

Progression-free survival (PFS) is defined as the time from randomisation to disease progression or death.

Secondary Efficacy Variables:

* Clinical benefit (CR+PR+SD)
* ORR (CR+PR)
* Time to progression
* Time to next Treatment (TTT)
* Overall survival
* Safety profile

Conditions

Interventions

DRUG

Paclitaxel and Sorafenib

intravenous solution, 80 mg/sqm, 3 times per cycle, with one cycle = 28 d and application at days 1, 8 and 15 AND pills (200mg), cycle 1: 400 mg / day cycle 2: 600 mg / day from cycle 3: 800 mg / day

DRUG

Paclitaxel

intravenous solution, 80 mg/sqm, 3 times per cycle, with one cycle = 28 d and application at days 1, 8 and 15

Sponsors & Collaborators

  • iOMEDICO AG

    collaborator INDUSTRY

  • Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH

    lead OTHER

Principal Investigators

  • Friedrich Overkamp, Dr. med.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-01
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • Germany

Study Locations

More Related Trials

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 NCT01320111 on ClinicalTrials.gov