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

Running, not enrolling · Phase 2

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00609791

Run by

City of Hope Medical Center

People needed

40

Starts

2008-02-11

Expected to finish

2027-03-23

Last updated by the study team

2026-06-04

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• City of Hope Medical Center — Duarte, California, United States
• City of Hope Medical Group — Pasadena, California, United States

Full record on ClinicalTrials.gov

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