Breast CancerPhase 2NCT00609791
Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients of Different Ages With Metastatic Breast Cancer
A Phase 2 study testing paclitaxel albumin-stabilized nanoparticle formulation, pharmacological study and physiologic testing in people with Breast Cancer, run by City of Hope Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- paclitaxel albumin-stabilized nanoparticle formulation, pharmacological study and physiologic testing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Feb 2008to 23 Mar 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of metastatic breast cancer
- Any estrogen receptor, progesterone receptor, or HER-2/neu status allowed as long as the patient will receive paclitaxel albumin-stabilized nanoparticle formulation alone
- First- or second-line chemotherapy treatment for metastatic disease planned
Who cannot join
- Untreated CNS metastases or symptomatic CNS metastases requiring escalating doses of corticosteroids
- PATIENT CHARACTERISTICS:
- Karnofsky performance status 70-100%
- WBC ≥ 3,000/mm³
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
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- Hemoglobin ≥ 9.0 g/dL
- AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2.5 times ULN (unless bone metastases are present in the absence of liver metastases)
- Bilirubin ≤ 1.5 mg/dL
- Peripheral neuropathy ≤ grade 1
- Creatinine clearance ≥ 30 mL/min (calculated or 24-hour)
- Negative pregnancy test
- Fertile patients must use effective contraception
- Not pregnant or nursing
- No known history of allergic reactions to paclitaxel
- No serious or uncontrolled infection
- Ability to understand and the willingness to sign a written informed consent document
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No ≥ grade 2 toxicity from prior therapy (other than alopecia)
- No taxane for adjuvant therapy or metastatic disease within the past 12 months
- No other concurrent investigational agents
- No other concurrent anticancer therapy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
City of Hope Medical Center
Duarte, California, 91010-3000
City of Hope Medical Group
Pasadena, California, 91105
About this study
Official title: Age-Related Changes in Nanoparticle Albumin Bound (Nab) Paclitaxel Pharmacokinetics and Pharmacodynamics
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.
Read the detailed description
OBJECTIVES:
Primary
- To determine age-related changes in the pharmacokinetics (pK) of weekly paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel) in patients with metastatic breast cancer.
- To determine age-related changes in the pharmacodynamics (toxicity) of nab-paclitaxel in these patients.
Secondary
- To determine response and time to progression in these patients.
- To explore predictors of pK parameters in these patients.
- To explore predictors of the need for dose reduction, dose delays, or grade 3 or 4 toxicity in these patients.
OUTLINE: Patients are stratified by age in years (< 50 vs 50-60 vs 60-70 vs > 70).
Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once daily on days 1, 8, and 15 as planned. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Blood is drawn for pharmacokinetic studies periodically during course 1.
Patients complete questionnaires regarding risk factors that would predict for pharmacokinetic parameters at baseline, prior to the third course of treatment, and at end of study. Data collected include medical characteristics, demographics, functional status, comorbidity, psychological status, social functioning and support, nutritional status, and cognition.
- Conditions
- Breast Cancer
- Being tested
- paclitaxel albumin-stabilized nanoparticle formulation, pharmacological study, physiologic testing, questionnaire administration, study of socioeconomic and demographic variables
- Keywords
- recurrent breast cancer, stage IV breast cancer, male breast cancer
- Medical subject headings
- Breast Neoplasms, Breast Neoplasms, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paclitaxel albumin-stabilized nanoparticle formulationDrug
100 mg/m2 3 weeks on 1 week off
Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 and 48 hours
physiologic testingOther
Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy
questionnaire administrationOther
Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy
study of socioeconomic and demographic variablesOther
Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy
cognitive assessmentProcedure or surgery
Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy
psychosocial assessment and careProcedure or surgery
Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy
| Study group | Role | What they receive |
|---|---|---|
| nab-paclitaxel | Experimental | Not described Receives: Drug: paclitaxel albumin-stabilized nanoparticle formulation; Other: pharmacological study; Other: physiologic testing; Other: questionnaire administration; Other: study of socioeconomic and demographic variables; Procedure: cognitive assessment; Procedure: psychosocial assessment and care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Area Under the Curve Over 24 Hours (AUC24)
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; cancer type
Measured: Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 hours post treatment
Mean Clearance (CL)
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
Measured: Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 hours post treatment
Secondary outcomes (6)
Grade 3 Toxicity Rate by Chemotherapy Toxicity Risk Score
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 Medium risk score - toxicity risk score: 6-9 High risk score - toxicity risk score: 10-19
Measured: Up to 2.5 years
Best Response
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 started.
Measured: Assessed after every 2 cycles of therapy until progression, up to 2.5 years
Median Event-free Survival (EFS) in Months
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
Measured: 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
Number of Participants Requiring Dose Reductions
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.
Measured: At the completion of treatment, up to 2.5 years
Number of Participants With a Dose Omission
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.
Measured: At the completion of treatment, up to 2.5 years
Percent of Participants With a Grade 3 Toxicity
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.
Measured: At the completion of treatment, up to 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2008 (estimated)
- Study start11 Feb 2008
- Primary completion25 Oct 2011
- Study completion23 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Mina Sedrak, MD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00609791
- Sponsor's protocol ID
- 07157
- Other IDs
- P30CA033572, CHNMC-07157, ABRAXIS-ABX206-BC07US, CDR0000586461, NCI-2011-02403
- Status last verified
- May 2026
- First submitted
- 6 Feb 2008
- Last updated
- 4 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Hurria A, Blanchard MS, Synold TW, Mortimer J, Chung CT, Luu T, Katheria V, Rotter AJ, Wong C, Choi A, Feng T, Ramani R, Doan CM, Brown J, Somlo G. Age-related changes in nanoparticle albumin-bound paclitaxel pharmacokinetics and pharmacodynamics: influence of chronological versus functional age. Oncologist. 2015 Jan;20(1):37-44. doi: 10.1634/theoncologist.2014-0202. Epub 2014 Dec 9.
PubMed 25492923