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

NCT00609791 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-06-19

Study results available
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Summary

RATIONALE: Gathering information from patients of different ages receiving paclitaxel albumin-stabilized nanoparticle formulation for metastatic breast cancer may help doctors understand how the age of the patient changes the way the drug works.

PURPOSE: This phase II trial is studying how well paclitaxel albumin-stabilized nanoparticle formulation works in treating patients of different ages with metastatic breast cancer.

Conditions

Interventions

DRUG

paclitaxel albumin-stabilized nanoparticle formulation

100 mg/m2 3 weeks on 1 week off

OTHER

pharmacological study

Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 and 48 hours

OTHER

physiologic testing

Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy

OTHER

questionnaire administration

Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy

OTHER

study of socioeconomic and demographic variables

Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy

PROCEDURE

cognitive assessment

Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy

PROCEDURE

psychosocial assessment and care

Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • City of Hope Medical Center

    lead OTHER

Principal Investigators

  • Mina Sedrak, MD · City of Hope Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-11
Primary Completion
2011-10-25
Completion
2026-04-24

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00609791 on ClinicalTrials.gov