Overview

This trial is active, not recruiting.

Conditions 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
Treatments paclitaxel albumin-stabilized nanoparticle formulation, questionnaire administration
Phase phase 2
Sponsor City of Hope Medical Center
Collaborator National Cancer Institute (NCI)
Start date June 2012
End date December 2017
Trial size 40 participants
Trial identifier NCT01463072, 11139, NCI-2011-03295

Summary

This phase II trial studies the side effects of paclitaxel albumin-stabilized nanoparticle formulation in treating older patients with breast cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or other places in the body (metastatic). Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing, or by stopping them from spreading.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
paclitaxel albumin-stabilized nanoparticle formulation ABI-007
Given IV
questionnaire administration
Ancillary studies

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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
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

Eligibility Criteria

Male or female participants at least 65 years old.

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 scale (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

Additional Information

Official title Efficacy and Tolerability of Nanoparticle Albumin Bound Paclitaxel (Abraxane) in Patients 65 and Older With Locally Advanced or Metastatic Breast Cancer
Principal investigator Arti Hurria
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by City of Hope Medical Center.
Location data was received from the National Cancer Institute and was last updated in October 2016.