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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

Study 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.Check my eligibility

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.See study design

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

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

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

Primary outcome measures

Mean Area Under the Curve Over 24 Hours (AUC24)

Mean Clearance (CL)

Secondary outcome measures

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

~960

cognitive assessment

2005

Completed Phase 3

~1210

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,113 Total Patients Enrolled

939 Trials studying Breast Cancer

1,543,320 Patients Enrolled for Breast Cancer

City of Hope Medical CenterLead Sponsor

565 Previous Clinical Trials

1,921,420 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

Frequently Asked Questions

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

To what extent has paclitaxel albumin-stabilized nanoparticle formulation been researched through controlled studies?

"Currently, 856 clinical trials for paclitaxel albumin-stabilized nanoparticle formulation have been initiated. Of those studies, 231 are in the advanced Phase 3 stage of testing. The vast majority of these experiments are based at Woolloongabba, Queensland; however there is a total 45894 locations conducting research into this treatment option."

Answered by AI

What condition is paclitaxel albumin-stabilized nanoparticle formulation commonly used to treat?

"Paclitaxel albumin-stabilized nanoparticle formulation is commonly employed to combat hypoalbuminemia. It can also be used for medical management of APN, shock, and non-small cell lung cancer in its later stages."

Answered by AI

Is there availability for individuals to join this research endeavor?

"Unfortunately, this particular medical trial is not currently recruiting patients. It was initially posted on February 11th 2008 and last modified August 8th 2022. If you are seeking out other trials related to breast cancer, there are 2596 studies actively enrolling individuals while 856 of those focus on paclitaxel albumin-stabilized nanoparticle formulation specifically."

Answered by AI

How many individuals are actively participating in this clinical research?

"As of August 8th 2022, this clinical trial has stopped accepting participants. It was initially posted on February 11th 2008 and the last update was made on August 8th 2022. Currently, there are 2596 trials related to breast cancer recruiting patients and 856 studies using paclitaxel albumin-stabilized nanoparticle formulation looking for volunteers."

Answered by AI

Does this trial encompass individuals beyond the age of 35?

"This scientific experiment is open to participants of legal age who are younger than 120 years old."

Answered by AI

Who meets the qualifications to participate in this research endeavor?

"To qualify for the trial, applicants must have breast cancer and fall within the age range of 18 to 120 years. The total number of participants being enrolled is 40."

Answered by AI

Has the paclitaxel albumin-stabilized nanoparticle formulation passed regulatory scrutiny for general use?

"Paclitaxel albumin-stabilized nanoparticle formulation is assessed to have a safety rating of 2, as this clinical trial has yet to confirm the efficacy of its therapeutic approach. Nevertheless, there exists ample data that suggests it is safe for human use."

Answered by AI

Recent research and studies

The OncologistJournal

Hurria, Arti, M. Suzette Blanchard, Timothy W. Synold, Joanne Mortimer, Cathie T. Chung, Thehang Luu, Vani Katheria, et al.. 2014. “Age-related Changes in Nanoparticle Albumin-bound Paclitaxel Pharmacokinetics and Pharmacodynamics: Influence of Chronological Versus Functional Age”. The Oncologist. Oxford University Press (OUP). doi:10.1634/theoncologist.2014-0202.

clinicaltrials.govStudy

Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients of Different Ages With Metastatic Breast Cancer

2008. "Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients of Different Ages With Metastatic Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00609791.

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