Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Older Patients With Locally Advanced or Metastatic Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01463072|
Recruitment Status : Active, not recruiting
First Posted : November 1, 2011
Last Update Posted : March 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Male Breast Cancer Recurrent Breast Cancer Stage IV Breast Cancer Estrogen Receptor-negative Breast Cancer Estrogen Receptor-positive Breast Cancer HER2-negative Breast Cancer HER2-positive Breast Cancer Progesterone Receptor-negative Breast Cancer Progesterone Receptor-positive Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer Triple-negative Breast Cancer||Drug: paclitaxel albumin-stabilized nanoparticle formulation Other: questionnaire administration||Phase 2|
PRIMARY OBJECTIVES: 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 locally advanced or metastatic breast cancer.
SECONDARY OBJECTIVES: I. To evaluate the efficacy (response and time to progression) of weekly nab-paclitaxel in older adults with locally advanced or 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 years).
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.
OUTLINE: 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Tolerability of Nanoparticle Albumin Bound Paclitaxel (Abraxane) in Patients 65 and Older With Locally Advanced or Metastatic Breast Cancer|
|Study Start Date :||June 19, 2012|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||November 2018|
Experimental: Treatment (chemotherapy)
Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: paclitaxel albumin-stabilized nanoparticle formulation
Other: questionnaire administration
- 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 [ Time Frame: 30 days after completion of last course of study treatment ]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.
- Determination of efficacy based upon best response to treatment and time to disease progression [ Time Frame: 30 days after completion of last course of study treatment ]Rates and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated for objective response rate (complete response [CR] + partial response [PR]) and clinical benefit rate (CR + PR + stable disease [SD]) as determined by Response Evaluation Criteria in Solid Tumors (RECIST). Progression free survival will be estimated using the product limit method of Kaplan and Meier.
- Use of a cancer-specific geriatric assessment to predict the need for dose reduction, dose delays, or occurence of grade 2-5 toxicity and neuropathy grade 2 or higher. [ Time Frame: 30 days after completion of last course of study treatment ]General linear models and graphical methods will be used to explore factors as identified by a cancer-specific geriatric assessment that may be predictive of toxicity/dose reduction or dose delays. Assessment consists of an evaluation of the individual's functional status, comorbid medical conditions, cognition, nutritional status, psychological state, and social support.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01463072
|United States, California|
|City of Hope Medical Center|
|Duarte, California, United States, 91010|
|City of Hope Antelope Valley|
|Lancaster, California, United States, 93534|
|South Pasadena Cancer Center|
|South Pasadena, California, United States, 91030|
|United States, Ohio|
|Ohio State University Comprehensive Cancer Center|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Arti Hurria||City of Hope Medical Center|