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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

Study Summary

This trial will study alisertib in combination with paclitaxel to find out if the two drugs together can help to control HR-positive, HER2-negative or HR-negative, HER2-negative (triple negative) locally recurrent or metastatic breast cancer.

Eligible Conditions

Breast Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to Disease Progression - Tumor Response based on RECIST criteria

Secondary outcome measures

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

~5380

Alisertib

2010

Completed Phase 2

~1140

Do I qualify?Apply below to find out

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent does Paclitaxel present a risk to human health?

"Given the Phase 2 status of Paclitaxel, our team at Power gave this drug a safety rating of 2; showing that there is preliminary clinical data to support its security but none demonstrating effectiveness."

Answered by AI

To what afflictions is Paclitaxel regularly prescribed?

"Paclitaxel is commonly prescribed to address neoplasm metastasis, but can also be beneficial for patients diagnosed with kaposi sarcoma, fallopian tubes cancer, and other medical concerns."

Answered by AI

Is enrollment currently available for this experiment?

"At this time, no new enrolments are being accepted into the trial. This study was initially advertised on February 12th 2015 and last updated November 29th 2022. As an alternative, if you are looking to join another medical trial there currently over four thousand eight hundred twenty-one clinical studies enrolling patients with breast cancer as well as eight hundred thirty-eight trials for Paclitaxel actively recruiting participants."

Answered by AI

How many participants is this clinical trial currently accommodating?

"Unfortunately, the recruitment window for this clinical trial has already closed. It was first posted on February 12th 2015 and last modified on November 29th 2022. Currently, there are 4821 trials involving breast cancer patients actively recruiting individuals and 838 studies looking at Paclitaxel that need participants."

Answered by AI

Could you please provide insight into other research endeavors that have centered around Paclitaxel?

"At the time being, 838 studies are active and investigating Paclitaxel. Of these trials, 227 have moved into Phase 3 of testing. The majority of those clinical trial sites are located in Adelaide, South Australia yet there exist a total of 45665 research centres researching this drug intervention."

Answered by AI

Recent research and studies

JAMA Network OpenJournal

Efficacy and Safety of Weekly Paclitaxel with or Without Oral Alisertib in Patients with Metastatic Breast Cancer

O’Shaughnessy, Joyce, Kristi McIntyre, Sharon Wilks, Ling Ma, Margaret Block, David Andorsky, Michael Danso, Tracy Locke, Amy Scales, and Yunfei Wang. 2021. “Efficacy and Safety of Weekly Paclitaxel with or Without Oral Alisertib in Patients with Metastatic Breast Cancer”. JAMA Network Open. American Medical Association (AMA). doi:10.1001/jamanetworkopen.2021.4103.

clinicaltrials.govStudy

Study to Compare Alisertib With Paclitaxel vs. Paclitaxel Alone in Metastatic or Locally Recurrent Breast Cancer

2015. "Study to Compare Alisertib With Paclitaxel vs. Paclitaxel Alone in Metastatic or Locally Recurrent Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02187991.

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