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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
No Placebo-Only Group
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed after every 2 cycles of therapy until progression, up to 2.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed after every 2 cycles of therapy until progression, up to 2.5 years
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~1070
cognitive assessment
2005
Completed Phase 3
~1210
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,957 Previous Clinical Trials
41,112,047 Total Patients Enrolled
942 Trials studying Breast Cancer
1,443,092 Patients Enrolled for Breast Cancer
City of Hope Medical CenterLead Sponsor
605 Previous Clinical Trials
1,923,565 Total Patients Enrolled
41 Trials studying Breast Cancer
4,837 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
Mina Sedrak, MDPrincipal InvestigatorCity of Hope Medical Center
5 Previous Clinical Trials
99,344 Total Patients Enrolled
1 Trials studying Breast Cancer
700 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My breast cancer has spread to other parts of my body.My breast cancer can be any type, but I will be treated with a specific chemotherapy drug.I am planning to start my first or second chemotherapy for advanced cancer.I have brain metastases that haven't been treated or need more steroids to manage symptoms.
Research Study Groups:
This trial has the following groups:- Group 1: nab-paclitaxel