AIRE - Assessing ImmunoResponse Post Eribulin: Eribulin and Immunogenicity in Advanced Breast Cancer - a Prospectively Randomized Phase IV Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Immune responsivity (IR)
研究概览
简要总结
After progression of disease after one chemotherapy, metastatic breast cancer patients will be randomized 1:1 to one of the following treatment arms:
Arm A. Eribulin Arm B. Paclitaxel
Blood draws for immune analysis will be performed before start of therapy, on day 1 of cycle 2 and on day 21 of cycle 4 (end of therapy) for the primary study aim. Patients will be treated under study conditions for a maximum of 4 therapy cycles.
详细描述
This is a prospective, randomized Phase IV study. Patients who progressed after one chemotherapy in the metastatic setting will be randomized 1:1 to one of the following treatment arms. Arm A. Eribulin 1.23 mg/m2 on days 1 and 8 q21d Arm B. Paclitaxel 80 mg/m2 on days 1, 8, and 15 q21d Blood draws for immune analysis will be performed before start of therapy on day 1 of cycle 1, on day 1 of cycle 2 (pre dose each) and on day 21 of cycle 4 (end of therapy) and assessed for the primary study aim. Patients will be treated under study conditions for a maximum of 4 therapy cycles.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Written informed consent prior to beginning of trial specific procedures
- •Subject must be female and aged ≥ 18 years on day of signing informed consent
- •Histologically confirmed, HER2 negative breast cancer determined by core biopsy of tumor lesion. Human epidermal growth factor receptor 2 (HER2) negativity is defined as either of the following by local laboratory assessment: In situ hybridization (ISH) non-amplified (ratio ≤ 2.2), or IHC 0 or IHC 1+.
- •Indication for chemotherapy
- •Previous therapy with one chemotherapy line
- •Target lesion (RECIST 1.1)
- •Adequate organ function defined as:
- •Creatinine Clearance > 50 ml/min ANC ≥ 1.5 x 10 3 /μL Thrombocytes > 100 x 10 3 /μL
排除标准
- •HER2 positive disease
- •Indication for an anti-hormone treatment
- •Active infection requiring systemic therapy.
- •Active autoimmune disease or other diseases that requires systemic treatment with corticosteroids or immunosuppressive drugs.
- •History of primary or acquired immunodeficiency (including allogenic organ transplant).
- •Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
- •Severely impaired liver function (Child Pugh C)
- •Hypersensitivity to study medication or any of its components
- •Neuropathy (PNP) > Grade 2 (CTCAE 5.0)
- •Congenital long QT syndrome
- •Preexisting concomitant use of strong CYP3A4 and CYP2C8 inhibiting or inducing drugs
- •Life expectancy of less than three months
- •Pregnancy (contraception is required according tocontraceptive guidance)
- •Lactation
- •Known history of following infections: Human immunodeficiency virus (HIV), History of acute or chronic Hepatitis B or Hepatitis C
- •Has received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted.
- •Does not agree to blood collection
研究组 & 干预措施
Eribulin
Arm A. Eribulin 1.23 mg/m^2, administered as an injection on day 1 and 8 q 21d for a maximum of 4 therapy cycles
干预措施: Eribulin Injection [Halaven] (Drug)
Paclitaxel
Paclitaxel 80 mg/m^2, administered as an injection on day 1, 8 and 15 q21d for a maximum of 4 therapy cycles
干预措施: Paclitaxel injection (Drug)
结局指标
主要结局
Immune responsivity (IR)
时间窗: 12 weeks after therapy start
defined as ≥ 5% of all T cells from peripheral blood are Ki-67 positive after chemotherapy
次要结局
- Progression free survival(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months)
- Overall survival(From date of randomization until the date of death from any cause, whichever came first, assessed up to 24 months)
- Toxicity and safety of eribulin and paclitaxel(Therapy start until 30 days post last dose)
- EORTC QLQC30(Therapy start until therapy end after 4 cycles up to 12 weeks)
- Overall response after three months(three months after therapy start)