Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients of Different Ages With Metastatic Breast Cancer
Active, enrolledPhase 2Results postedLast updated 19 June 2025
What this trial tests
Phase 2 trial testing paclitaxel albumin-stabilized nanoparticle formulation in Breast Cancer in 40 participants. Participants enrolled and being followed up; not accepting new ones.
Adults 18 to 120, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Mean Area Under the Curve Over 24 Hours (AUC24)Primary· Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 hours post treatment
Mean of area under the curve over 24 hours (AUC24) reported as well as linear regression of AUC24 by age and chemotherapy toxicity risk score.
Chemotherapy toxicity risk score is based on the following variables and the value assigned to them. Higher scores indicate more risk, range of 2-19:
patient age (\>=72 years); creatinine clearance (\<34 mL/min); presence of amenia (\<10 g/dL); hearing impairment; falls in the last 6 months; need for assistance with taking medications; limitations in walking one block; decreased social activities; chemotherapy dosing; number of chemotherapy drugs; can
Group
Value
95% CI
Nab-paclitaxel
4711
± 2777
Mean Clearance (CL)Primary· Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 hours post treatment
Mean CL reported as well as regression results of CL by age and chemotherapy toxicity risk score.
Chemotherapy toxicity risk score is based on the following variables and the value assigned to them. Higher scores indicate more risk, range of 2-19:
patient age (\>=72 years); creatinine clearance (\<34 mL/min); presence of amenia (\<10 g/dL); hearing impairment; falls in the last 6 months; need for assistance with taking medications; limitations in walking one block; decreased social activities; chemotherapy dosing; number of chemotherapy drugs; cancer type
Group
Value
95% CI
Nab-paclitaxel
37.16
± 14.81
Grade 3 Toxicity Rate by Chemotherapy Toxicity Risk ScoreSecondary· Up to 2.5 years
Comparison of presence of grade 3 toxicity rate by risk score distribution.
Chemotherapy toxicity risk score is based on the following variables. Higher scores indicate more risk, range of 2-19:
patient age (\>=72 years); creatinine clearance (\<34 mL/min); presence of amenia (\<10 g/dL); hearing impairment; falls in the last 6 months; need for assistance with taking medications; limitations in walking one block; decreased social activities; chemotherapy dosing; number of chemotherapy drugs; cancer type
Chemotherapy toxicity risk score category:
Low risk score - toxicity risk score: 0-5 Me
Low risk score : Grade 3 toxicity
Group
Value
95% CI
Nab-paclitaxel
5
Low risk score : No grade 3 toxicity
Group
Value
95% CI
Nab-paclitaxel
25
Medium risk score : Grade 3 toxicity
Group
Value
95% CI
Nab-paclitaxel
3
Medium risk score : No grade 3 toxicity
Group
Value
95% CI
Nab-paclitaxel
3
High risk score : Grade 3 toxicity
Group
Value
95% CI
Nab-paclitaxel
2
High risk score : No grade 3 toxicity
Group
Value
95% CI
Nab-paclitaxel
1
Best ResponseSecondary· Assessed after every 2 cycles of therapy until progression, up to 2.5 years
Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment starte
Group
Value
95% CI
Nab-paclitaxel
12
Nab-paclitaxel
15
Nab-paclitaxel
10
Nab-paclitaxel
2
Median Event-free Survival (EFS) in MonthsSecondary· From the date treatment begins until the first date on which recurrence, progression or death due to any cause, assessed up to 3.5 years
Median and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated for EFS. EFS will be estimated using the product limit method of Kaplan and Meier.
EFS is defined by time to disease recurrence, disease progression or death to due to any cause
Group
Value
95% CI
Nab-paclitaxel
5.7
3.2 – 9.2
Number of Participants Requiring Dose ReductionsSecondary· At the completion of treatment, up to 2.5 years
Number of participants requiring a dose reduction is reported and analysis was performed using a student's 2 sample t test to determine the need of dose reductions based on age, AUC, and CL.
Group
Value
95% CI
Nab-paclitaxel
11
Number of Participants With a Dose OmissionSecondary· At the completion of treatment, up to 2.5 years
Number of participants with a dose omission is reported and analysis was performed using a student's 2 sample t test to determine the need of dose omission based on age, AUC, and CL.
Group
Value
95% CI
Nab-paclitaxel
15
Percent of Participants With a Grade 3 ToxicitySecondary· At the completion of treatment, up to 2.5 years
Percent of participants experiencing a grade 3 toxicity is reported and analysis was performed using a student's 2 sample t test to determine the presence of grade 3 toxicity based on age, AUC, and CL.
Group
Value
95% CI
Nab-paclitaxel
26
13 – 42
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 3.5 years.
Reporting threshold: 2%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Nab-paclitaxel
Serious: 2/39 (5%)
Deaths: 26/39
Serious adverse events (2 terms)
Reaction
System
Nab-paclitaxel
Urinary tract infection
Infections and infestations
—
Skin infection
Infections and infestations
—
Other adverse events (144 terms — click to expand)
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by City of Hope Medical Center
Last refreshed: 19 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00609791.