NCT00609791Active, not recruitingPhase 2
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 · Last updated 4 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 6 Feb 2008
- Start date
- 11 Feb 2008
- Primary completion date
- 25 Oct 2011
- Lead sponsor
- City of Hope Medical Center
- Diseases
- Metastatic breast cancer
- NCT number
- NCT00609791
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 40
- From 11 Feb 2008 to the primary completion date, 25 Oct 2011
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Untreated CNS metastases or symptomatic CNS metastases requiring escalating doses of corticosteroids
- PATIENT CHARACTERISTICS:
- Ability to understand and the willingness to sign a written informed consent document
- PRIOR CONCURRENT THERAPY:
- No ≥ grade 2 toxicity from prior therapy (other than alopecia)
- No other concurrent investigational agents
- No other concurrent anticancer therapy
Other illness
- No known history of allergic reactions to paclitaxel
- No serious or uncontrolled infection
- See Disease Characteristics
- No taxane for adjuvant therapy or metastatic disease within the past 12 months
Lab values
- 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
- Creatinine clearance ≥ 30 mL/min (calculated or 24-hour)
Other
- Karnofsky performance status 70-100%
- Peripheral neuropathy ≤ grade 1
- Negative pregnancy test
- Fertile patients must use effective contraception
- Not pregnant or nursing
Who the study is looking for
- 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
Criteria the registry did not label
- DISEASE CHARACTERISTICS:
Age in the registry: 18 years to 120 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| City of Hope Medical Center Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| City of Hope Medical Group Coordinator of this site? Confirm its status | Pasadena | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.