Efficacy and Tolerability of Nanoparticle Albumin Bound Paclitaxel (Abraxane) in Patients 65 and Older With Metastatic Breast Cancer
I. To evaluate the tolerability (grade 2-5 toxicity, neuropathy grade 2 or higher, need for
dose reductions, or delays) of weekly nab-paclitaxel (paclitaxel albumin-stabilized
nanoparticle formulation) in older adults with metastatic breast cancer.
I. To evaluate the efficacy (response and time to progression) of weekly nab-paclitaxel in
older adults with metastatic breast cancer using a stratification factor based on patient
age (at least 5 patients age 75 years or older and no more than 15 patients age 65-70
II. To explore predictors of the need for dose reduction, dose delays, or grade 2-5 toxicity
and neuropathy grade 2 or higher based on a cancer-specific geriatric assessment.
Patients receive paclitaxel albumin-stabilized nanoparticle formulation intravenously (IV)
over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Tolerability (grade 2-5 toxicity, neuropathy grade 2 or higher, dose reductions, delays or interruptions) using National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 4.0
Rates and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated. Tables will be created to summarize the toxicities and side effects by course, organ, and severity for all patients. We will describe toxicities on a patient by patient basis. Numbers of courses received and dose reductions will be tabulated.
30 days after completion of last course of study treatment
City of Hope Medical Center
United States: Institutional Review Board
|City of Hope Medical Center||Duarte, California 91010|
|South Pasadena Cancer Center||South Pasadena, California 91030|