Clinical trial · Interventional
Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients of Different Ages With Metastatic Breast Cancer
Age-Related Changes in Nanoparticle Albumin Bound (Nab) Paclitaxel Pharmacokinetics and Pharmacodynamics
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cognitive assessment | Procedure | — | UNRESOLVED |
| paclitaxel albumin-stabilized nanoparticle formulation | Drug | Nab-paclitaxel | ALIAS |
| pharmacological study | Other | — | UNRESOLVED |
| physiologic testing | Other | — | UNRESOLVED |
| psychosocial assessment and care | Procedure | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
| study of socioeconomic and demographic variables | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- nab-paclitaxel
- interventionNames
- 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
Primary outcomes (2)
- measure
- Mean Area Under the Curve Over 24 Hours (AUC24)
- timeFrame
- Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 hours post treatment
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Inclusion criteria: * 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 Exclusion criteria: * 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 * 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
References
Publications (1)
- DERIVEDHurria 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. PMID 25492923