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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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

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 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.

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

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 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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Paclitaxel

Arm Intervention/treatment
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
Correlative studies

Drug: Nab-paclitaxel
Given IV
Other Names:
  • ABI 007
  • ABI-007
  • Abraxane
  • Albumin-bound Paclitaxel
  • Albumin-Stabilized Nanoparticle Paclitaxel
  • Nanoparticle Albumin-bound Paclitaxel
  • Nanoparticle Paclitaxel
  • Paclitaxel Albumin
  • paclitaxel albumin-stabilized nanoparticle formulation
  • protein-bound paclitaxel

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. Time to progression [ Time Frame: Up to 3 years ]
    Progression free survival will be estimated using the product limit method of Kaplan and Meier.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Mina Sedrak City of Hope Medical Center
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Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT01463072    
Other Study ID Numbers: 11139
NCI-2011-03295 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
118196
124494
11139 ( Other Identifier: City of Hope Comprehensive Cancer Center )
P30CA033572 ( U.S. NIH Grant/Contract )
First Posted: November 1, 2011    Key Record Dates
Last Update Posted: November 4, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Carcinoma
Breast Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action