Efficacy and Tolerability of Nanoparticle Albumin Bound Paclitaxel (Abraxane) in Patients 65 and Older With Locally Advanced or Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 7
- 主要终点
- Percent of Participants With Grade 2-5 Toxicity Using National Cancer Institute Common Toxicity Criteria Version 4.0
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Laboratory Biomarker Analysis (Other)
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.
干预措施: Nab-paclitaxel (Drug)
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.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Percent of Participants With Grade 2-5 Toxicity Using National Cancer Institute Common Toxicity Criteria Version 4.0
时间窗: During and after treatment, up to 2.5 years
Will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Rates and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated for grade 2 or higher toxicities attributed to treatment.
Percent of Participants With Grade 3 or Higher Toxicities Attributable to Treatment
时间窗: On treatment, 28 days per cycle up to 30 months
Will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Rates and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated for grade 3 or higher toxicities attributed to treatment.
Rate of Participants With a Dose Reduction
时间窗: On treatment, up to 30 months
Rates and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated for dose reduction.
Rate of Participants Requiring Dose Holds
时间窗: While on treatment, up to 30 months
Rates and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated for dose reduction.
次要结局
- Response Determined by Response Evaluation Criteria in Solid Tumors(Up to 2.5 years)
- Median Progression Free Survival (PFS)(From the date treatment begins until the first date on which recurrence, progression, or death due to any cause, assessed for about 1.5 years)
- Cancer-specific Geriatric (CARG) Assessment(CARG measured prior to treatment, toxicities and dose reduction measured up to 30 months)