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Anti-microtubule agent

Nanoparticle Chemotherapy for Breast Cancer

Phase 2
Waitlist Available
Led By Arti Hurria, MD
Research Sponsored by City of Hope Medical Center
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 assessed after every 2 cycles of therapy until progression, up to 2.5 years
Awards & highlights

Summary

This trial is testing how well a paclitaxel albumin-stabilized nanoparticle formulation works in treating patients of different ages with metastatic breast cancer.

Who is the study for?
This trial is for individuals with metastatic breast cancer, regardless of hormone receptor status, who are planning to receive their first or second round of chemotherapy. It's not suitable for those with untreated brain metastases or symptoms needing increasing steroid doses.
What is being tested?
The study focuses on how well a drug called paclitaxel albumin-stabilized nanoparticle formulation works in treating different age groups with advanced breast cancer. It includes cognitive and psychosocial assessments, pharmacological studies, and questionnaires.
What are the potential side effects?
Possible side effects include allergic reactions, low blood cell counts leading to increased infection risk and bleeding problems, nerve damage causing numbness or pain, muscle and joint pain, nausea, vomiting, diarrhea or mouth sores.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed after every 2 cycles of therapy until progression, up to 2.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed after every 2 cycles of therapy until progression, up to 2.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean Area Under the Curve Over 24 Hours (AUC24)
Mean Clearance (CL)
Secondary study objectives
Best Response
Grade 3 Toxicity Rate by Chemotherapy Toxicity Risk Score
Median Event-free Survival (EFS) in Months
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: nab-paclitaxelExperimental Treatment7 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
psychosocial assessment and care
2003
Completed Phase 4
~9920
paclitaxel albumin-stabilized nanoparticle formulation
2008
Completed Phase 2
~1010
cognitive assessment
2005
Completed Phase 3
~1210

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,960 Total Patients Enrolled
944 Trials studying Breast Cancer
1,543,924 Patients Enrolled for Breast Cancer
City of Hope Medical CenterLead Sponsor
596 Previous Clinical Trials
1,923,497 Total Patients Enrolled
42 Trials studying Breast Cancer
6,609 Patients Enrolled for Breast Cancer
Arti Hurria, MDPrincipal InvestigatorCity of Hope Comprehensive Cancer Center
10 Previous Clinical Trials
2,279 Total Patients Enrolled
5 Trials studying Breast Cancer
666 Patients Enrolled for Breast Cancer

Media Library

Paclitaxel Albumin-Stabilized Nanoparticle Formulation (Anti-microtubule agent) Clinical Trial Eligibility Overview. Trial Name: NCT00609791 — Phase 2
Breast Cancer Research Study Groups: nab-paclitaxel
~2 spots leftby Sep 2025
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