Nab-Paclitaxel in Treating Older Patients With Locally Advanced or Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT01463072|
Recruitment Status : Active, not recruiting
First Posted : November 1, 2011
Last Update Posted : November 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Locally Advanced Breast Carcinoma Metastatic Breast Carcinoma Recurrent Breast Carcinoma Stage III Breast Cancer AJCC v7 Stage IIIA Breast Cancer AJCC v7 Stage IIIB Breast Cancer AJCC v7 Stage IIIC Breast Cancer AJCC v7 Stage IV Breast Cancer AJCC v6 and v7||Other: Laboratory Biomarker Analysis Drug: Nab-paclitaxel Other: Questionnaire Administration||Phase 2|
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 advanced or metastatic breast cancer.
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.
Patients receive nab-paclitaxel intravenously (IV) over 30 minutes on days 1, 8, and 15. Cycles 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|
|Actual Study Start Date :||June 19, 2012|
|Estimated Primary Completion Date :||August 14, 2020|
|Estimated Study Completion Date :||September 14, 2020|
Experimental: Treatment (nab-paclitaxel)
Patients receive nab-paclitaxel IV over 30 minutes on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Other: Questionnaire Administration
- Tolerability, defined as incidence of grade 2-5 toxicity, neuropathy grade 2 or higher, dose reductions, delays or interruptions using National Cancer Institute Common Toxicity Criteria version 4.0 [ Time Frame: Up to 3 years ]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. Toxicities will be described on a patient by patient basis. Numbers of courses received and dose reductions will be tabulated.
- Response determined by Response Evaluation Criteria in Solid Tumors [ Time Frame: Up to 3 years ]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).
- Time to progression [ Time Frame: Up to 3 years ]Progression free survival will be estimated using the product limit method of Kaplan and Meier.
- 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 [ Time Frame: Up to 3 years ]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|
|Duarte, California, United States, 91010|
|City of Hope Antelope Valley|
|Lancaster, California, United States, 93534|
|City of Hope South Pasadena|
|South Pasadena, California, United States, 91030|
|United States, Ohio|
|Ohio State University Comprehensive Cancer Center|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Mina Sedrak||City of Hope Medical Center|