Phase II Multicentre Open Label Trial Evaluating the Efficacy and Safety of the Liposomal Doxorubicin (Myocet®) and Docetaxel (Taxotere®) Combination as First-line Treatment of Patients With Metastatic HER2/Neu Negative Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 10
- 主要终点
- Cardiotoxicity (definite or probable cardiac death)
研究概览
简要总结
This is an open phase II multicentre study evaluating the efficacy and safety of the non pegylated liposomal doxorubicin (Myocet®) and docetaxel (Taxotere®) combination as first-line treatment of patients with metastatic HER2/neu negative breast cancer.
详细描述
Phase II non comparative study, assessing the safety (primarily cardiac safety) and efficacy in patients with locally advanced or metastatic HER2/neu negative breast cancer not yet treated with chemotherapy for metastatic disease.
Myocet and Taxotere will be given for a maximum of 6 cycles. Endpoints: cardiotoxicity (left ventricular ejection fraction decrease and/or symptoms of heart failure), serious other toxicity, disease progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women with histologically documented metastatic or locally advanced metastatic HER2/neu negative breast cancer.
- •In the case of previous adjuvant or neoadjuvant chemotherapy with anthracyclines or taxanes, this must have been completed more than 12 months before inclusion.
- •In the case of previous adjuvant or neoadjuvant chemotherapy, cumulative anthracycline dose ≤ 360 mg/m2 of doxorubicin or 600 mg/m2 of epirubicin or 75 mg/m2 of mitoxantrone on inclusion.
- •Previous endocrine therapy is authorized (endocrine therapy other than goserelin must be stopped before starting treatment).
- •Previous radiotherapy is authorized, if discontinued ≥ 4 weeks prior to inclusion in the study and if < 10% of the bone marrow was within the irradiated area.
- •Age ≥ 18 years.
- •Performance status 0,1, or
- •Life expectancy ≥ 3 months.
- •Evaluable disease.
- •Normal LVEF (multigated acquisition [MUGA] scan or echocardiography).
- •Normal haematological, hepatic and renal parameters: neutrophils ≥ 1.5 x 10^9/l; platelets ≥ 100 x 10^9/l; hemoglobin (Hb) ≥ 6 mmol/L; total bilirubin ≤ 1.5 times the upper limit of normal (ULN); transaminases ≤ 2.5 x ULN; alkaline phosphatase ≤ 2.5 x ULN; creatinine ≤ 1.5 x ULN.
- •Dated and signed written informed consent.
排除标准
- •Previous chemotherapy for metastatic disease.
- •History of other cancer, except for cervical carcinoma in situ treated by cone resection or basal cell or squamous cell skin cancer.
- •History of congestive heart failure or myocardial infarction ≤ 1 year; cardiac function: NYHA ≥ 2 or LVEF < 50%. Uncontrolled significant heart disease, such as unstable angina.
- •Poorly controlled hypertension.
- •Performance status 3,
- •Symptomatic or progressive brain metastases.
- •Active infection or other serious underlying disease.
- •Concomitant participation in other clinical trials.
- •Pregnant women or nursing mothers; patients of childbearing potential without effective contraception.
- •Absolute medical contraindication to the use of corticosteroid premedication.
- •Allergy to polysorbate 80, doxorubicin, or egg lecithin.
- •NCI-CTC grade > 1 peripheral neuropathy.
- •Patients not able to comply with regular medical follow-up
研究组 & 干预措施
1.
Myocet+docetaxel
干预措施: Non pegylated liposomal doxorubicin and docetaxel (Drug)
结局指标
主要结局
Cardiotoxicity (definite or probable cardiac death)
时间窗: treatment period
Signs or symptoms of congestive heart failure (CHF), New York Heart Association (NYHA) class III-IV
时间窗: treatment period
Decline in LVEF of ≥ 10% to < 50% without signs or symptoms of CHF
时间窗: treatment period
Decline in left ventricular ejection fraction (LVEF) of ≥ 5% to < 50% with mild signs or symptoms of CHF (NYHA class < III)
时间窗: treatment period
次要结局
- Response rate(treatment period)
- Progression free survival(treatment period)
- Frequency and severity of intercurrent events according to the National Cancer Institute - Common Terminology Criteria (NCI-CTC) classification(treatment period)
- Median time to progression(treatment period)