EFFECT: A Randomized Phase II Study to Evaluate the EFficacy and Impact on Function of Two Different Doses of Nab-paclitaxEl in Elderly Patients With advanCed breasT Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 14
- 主要终点
- Event-free survival (EFS)
研究概览
简要总结
This is a randomized study evaluating the efficacy and impact on function of two different doses of nab-Paclitaxel in elderly patients with advanced breast cancer.
详细描述
This open-label, randomized phase II trial evaluates in parallel two doses of nab-Paclitaxel (100 and 125mg/m2) given weekly for 3 weeks every 28 days, in elderly women aged 65 years or older, as first line treatment for advanced breast cancer (locally recurrent or metastatic). A short geriatric evaluation of co-morbidity and functional status will be performed before study entry. The functional status will be monitored at baseline and at every cycles during treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed breast cancer, locally recurrent and/or metastatic; any estrogen/progesterone receptor status; HER2 receptor negative OR HER2 positive but with contraindication to anti-HER2 therapy (e.g. known congestive cardiac failure).
- •Measurable disease or non-measurable but evaluable disease according to RECIST 1.1 criteria
- •ECOG performance status 0-2
- •Estimated life expectancy of ≥ 12 weeks
- •No known active/symptomatic CNS metastases
- •No previous chemotherapy for breast cancer in the advanced setting
- •Adequate organ function including ( Hemoglobin ≥ 9g/dL; Absolute neutrophil count ≥ 1.5 x 10^9/L; Platelets ≥ 100 x 10^9/L; Bilirubin ≤ 1.5 mg/dL; ALT and AST ≤ 3 x ULN (with or without known hepatic metastases); ALP ≤ 2.5 x ULN; Serum creatinine ≤ 1.5 ULN or calculated creatinine clearance (CrCl) ≥ 50mL/min according to the Cockcroft Gault formula
- •Written informed consent (according to ICH/GCP and national/local regulations)
排除标准
- •Significant peripheral neuropathy (significant peripheral neuropathy is defined as ≥ grade 2 on CTCAE v4.0 criteria)
- •Clinically significant comorbidities including: uncontrolled cardiac arrhythmias (except rate-controlled atrial fibrillation), NYHA class III or IV cardiac failure, uncontrolled diabetes, hypertension or other medical conditions that may interfere with assessment of toxicity
- •Other malignancy within the last 5 years, except for adequately treated non-melanomatous skin cancers, cervical intraepithelial neoplasia or cervical carcinoma in situ
- •Intake of any concomitant medications or therapies that may potentially interact with the trial agent. Any prohibited medication must be discontinued at least 14 days prior to trial entry
- •Presence of any psychological, familial, sociological or geographical condition that may potentially hamper compliance with the study protocol and follow-up schedule; these conditions should be discussed with the patient before trial registration
研究组 & 干预措施
Arm A
Nab-paclitaxel 100 mg/mq weekly for 3 out of every 4 weeks
干预措施: Nab-paclitaxel (Drug)
Arm B
Nab-paclitaxel 125 mg/mq weekly for 3 out of every 4 weeks
干预措施: Nab-paclitaxel (Drug)
结局指标
主要结局
Event-free survival (EFS)
时间窗: Every 12 weeks, until disease progression or death or trial completion (12 months after randomization of the last patient).
Event is defined as either disease progression or death, or functional decline. Functional decline is defined as decreased in at least 1 point from baseline ADL, and/or IADL, as confirmed by the investigator as treatment-related and confirmed at the subsequent cycle
次要结局
- Objective response rate (ORR)(Every 12 weeks, until disease progression or trial completion (12 months after randomization of the last patient).)
- Clinical benefit rate (CBR)(Every 12 weeks, until disease progression or trial completion (12 months after randomization of the last patient))
- Progression free survival (PFS)(Every 12 weeks, until disease progression or death or trial completion (12 months after randomization of the last patient))
- Overall survival (OS)(Every 12 weeks until death or trial completion (12 months after randomization of the last patient))
- Incidence of adverse events(Every 12 weeks until event occurrence or trial completion (12 months after randomization of the last patient))