NCT01463072Active, not recruitingPhase 2
Nab-Paclitaxel in Treating Older Patients With Locally Advanced or Metastatic Breast Cancer
Efficacy and Tolerability of Nanoparticle Albumin Bound Paclitaxel (Abraxane) in Patients 65 and Older With Locally Advanced or Metastatic Breast Cancer
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
This phase II trial studies the side effects of nab-paclitaxel in treating older patients with breast cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or to other places in the body (metastatic). Drugs used in chemotherapy, such as nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 25 Oct 2011
- Start date
- 20 Jun 2012
- Primary completion date
- 17 May 2017
- Lead sponsor
- City of Hope Medical Center
- Diseases
- Metastatic breast cancer
- NCT number
- NCT01463072
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 40
- From 20 Jun 2012 to the primary completion date, 17 May 2017
- 4 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
- Patients may not be receiving any other investigational agents
- Untreated central nervous system (CNS) metastases or symptomatic CNS metastases requiring escalating doses of corticosteroids
Other illness
- Known history of allergic reactions to paclitaxel
- Presence of any serious or uncontrolled infection
- Receipt of a taxane for adjuvant therapy or metastatic disease in the last 12 months
Who the study is looking for
- Locally advanced or metastatic breast cancer
- Any estrogen receptor (ER), progesterone receptor (PR), or human epidermal growth factor receptor 2 (Her2neu) status as long as the patient will receive nab-paclitaxel alone
- First or second line chemotherapy treatment for metastatic disease
- Karnofsky performance status (KPS) \>= 70%
- Resolution of grade \>= 2 toxicity from prior therapy (other than alopecia)
- Peripheral neuropathy =\< grade 1
- Absolute neutrophil count \>= 1,500/mm\^3
- Platelets \>= 100,000 cells/mm\^3
- Hemoglobin (Hb) \>= 9.0 g/dl
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x institutional upper limit of normal
- Alkaline phosphatase =\< 2.5 x upper limit of normal unless bone metastasis are present in the absence of liver metastases
- Bilirubin =\< 1.5 mg/dl
- Creatinine clearance (calculated or 24 hour) \>= 30 ml/min
- Ability to understand and the willingness to sign a written informed consent document
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ohio State University Comprehensive Cancer Center Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| City of Hope medical Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| City of Hope Antelope Valley Coordinator of this site? Confirm its status | Lancaster | United States | Unknown status |
| City of Hope South Pasadena Coordinator of this site? Confirm its status | South Pasadena | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.