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Anti-mitotic Agent

sorafenib tosylate for Breast Cancer

Phase 2
Waitlist Available
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at time of death
Awards & highlights

Study Summary

This trial is studying paclitaxel with or without sorafenib to see how well they work in treating patients with breast cancer.

Eligible Conditions
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at time of disease progression
This trial's timeline: 3 weeks for screening, Varies for treatment, and at time of disease progression for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free survival
Secondary outcome measures
Duration of overall response
Overall response rate
Overall survival
+2 more

Side effects data

From 2014 Phase 2 trial • 20 Patients • NCT01502410
20%
Pain
10%
Lipase increased
10%
Hypoalbuminemia
10%
Respiratory, thoracic and mediastinal disorders - Other
10%
Anorexia
10%
Pericardial effusion
10%
Atelectasis
10%
Blood bilirubin increased
10%
Neutrophil count decreased
10%
Musculoskeletal and connective tissue disorder - Other
10%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
10%
Pleural effusion
10%
Rash maculo-papular
10%
Alkaline phosphatase increased
10%
Hypocalcemia
10%
Hypophosphatemia
10%
Back pain
10%
Diarrhea
10%
Neck pain
10%
Lung infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 1 Relapsed/Refractory Rhabdomyosarcoma
Group 2 Relapsed/Refractory Wilms Tumor

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm IExperimental Treatment2 Interventions
Patients receive paclitaxel IV over 1 hour once weekly for 3 weeks. Patients also receive oral sorafenib tosylate twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Group II: Arm IIActive Control2 Interventions
Patients receive paclitaxel as in arm I and oral placebo twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
FDA approved
Sorafenib
FDA approved

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,585 Previous Clinical Trials
917,051 Total Patients Enrolled
38 Trials studying Breast Cancer
12,295 Patients Enrolled for Breast Cancer
AmgenIndustry Sponsor
1,370 Previous Clinical Trials
1,377,508 Total Patients Enrolled
44 Trials studying Breast Cancer
78,966 Patients Enrolled for Breast Cancer
William J. Gradishar, MDStudy ChairRobert H. Lurie Cancer Center
8 Previous Clinical Trials
1 Total Patients Enrolled
7 Trials studying Breast Cancer
1 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Phase 2b Study of Taxol Plus Sorafenib or Placebo in Patients With Advanced Breast Cancer
2007. "Phase 2b Study of Taxol Plus Sorafenib or Placebo in Patients With Advanced Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00499525.
All > Breast
~10 spots leftby Apr 2025
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