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A Phase II Study Of Abraxane and Nexavar in the First-Line Treatment of Locally Advanced or Metastatic Breast Cancer

NCT00607438 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2012-05-11

No results posted yet for this study

Summary

This is a Phase II, open-label, non-randomized study in patients with locally advanced or metastatic breast cancer.

Each cycle will be 4 weeks in length. Patients will receive Abraxane weekly for 3 weeks. Patients will not receive Abraxane during week 4 (rest week). Nexavar will be given continuously.

Patients will be radiologically evaluated every 8 weeks for response. Patients will continue to receive study treatment until disease progression or unacceptable toxicity.

Conditions

Interventions

DRUG

Paclitaxel Albumin Nanoparticle for Injectable Suspension (Abraxane)

125 mg/m2 Paclitaxel by 30-minute IV infusion weekly for 3 weeks.

DRUG

Sorafenib (Nexavar)

400 mg orally twice a day continuously (even during rest week) starting on Day 1.

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Celgene Corporation

    collaborator INDUSTRY

  • Veeda Oncology

    lead OTHER

Principal Investigators

  • Barry Mirtsching, MD · Veeda Oncology

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • United States

Study Locations

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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 NCT00607438 on ClinicalTrials.gov