Status:
ACTIVE_NOT_RECRUITING
Nab-Paclitaxel in Treating Older Patients With Locally Advanced or Metastatic Breast Cancer
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Locally Advanced Breast Carcinoma
Metastatic Breast Carcinoma
Eligibility:
All Genders
65+ years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
PRIMARY OBJECTIVE: I. To evaluate the tolerability (grade 2-5 toxicity, neuropathy grade 2 or higher, need for dose reductions, or delays) of weekly nab-paclitaxel in older adults with locally advanc...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Patients may not be receiving any other investigational agents
- Untreated central nervous system (CNS) metastases or symptomatic CNS metastases requiring escalating doses of corticosteroids
- 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
Key Trial Info
Start Date :
June 19 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 18 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01463072
Start Date
June 19 2012
End Date
May 18 2026
Last Update
July 28 2025
Active Locations (4)
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1
City of Hope medical
Duarte, California, United States, 91010
2
City of Hope Antelope Valley
Lancaster, California, United States, 93534
3
City of Hope South Pasadena
South Pasadena, California, United States, 91030
4
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210