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Aurora kinase inhibitor

Alisertib + Paclitaxel for Breast Cancer

Phase 2
Waitlist Available
Led By Joyce A. O'Shaughnessy, MD
Research Sponsored by US Oncology Research
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 12 months
Awards & highlights

Summary

This trial is testing if a new drug called alisertib, combined with the chemotherapy drug paclitaxel, can help treat certain types of breast cancer that are hard to treat. Alisertib blocks a protein that helps cancer cells grow, and paclitaxel stops the cells from dividing. The combination might be more effective than using either drug alone.

Eligible Conditions
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to Disease Progression - Tumor Response based on RECIST criteria
Secondary study objectives
Number of Participants with Serious and Non-Serious Adverse Events
Number of Patients with Genetic Biomarker Expression in Tumor Tissue

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Triple Negative Paclitaxel plus AlisertibExperimental Treatment2 Interventions
Paclitaxel 60 mg/m2 intravenously (IV) on days 1, 8 and 15 of a 28-day cycle; Alisertib 40 mg BID on days 1-3, 8-10, and 15-17 of a 28-day cycle
Group II: ER+/HER2- Paclitaxel plus AlisertibExperimental Treatment2 Interventions
Paclitaxel 60 mg/m2 intravenously (IV) on days 1, 8 and 15 of a 28-day cycle; Alisertib 40 mg BID on days 1-3, 8-10, and 15-17 of a 28-day cycle
Group III: Triple Negative Paclitaxel AloneActive Control1 Intervention
Paclitaxel 90 mg/m2 IV on days 1, 8 and 15 of a 28-day cycle
Group IV: ER+/HER2- Paclitaxel AloneActive Control1 Intervention
Paclitaxel 90 mg/m2 IV on days 1, 8 and 15 of a 28-day cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5810
Alisertib
2010
Completed Phase 2
~1140

Find a Location

Who is running the clinical trial?

Millennium Pharmaceuticals, Inc.Industry Sponsor
404 Previous Clinical Trials
46,739 Total Patients Enrolled
1 Trials studying Breast Cancer
118 Patients Enrolled for Breast Cancer
US Oncology ResearchLead Sponsor
37 Previous Clinical Trials
17,287 Total Patients Enrolled
4 Trials studying Breast Cancer
4,077 Patients Enrolled for Breast Cancer
Joyce A. O'Shaughnessy, MDPrincipal InvestigatorUS Oncology Research, McKesson Specialty Health
3 Previous Clinical Trials
268 Total Patients Enrolled
1 Trials studying Breast Cancer
10 Patients Enrolled for Breast Cancer
~17 spots leftby Sep 2025
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