Phase IV.III Clinical Trial to Evaluate Maintenance Treatment With Caelyx vs. Observation After Administration of Induction Chemotherapy in Metastatic Breast Cancer Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 288
- 试验地点
- 1
- 主要终点
- Time to progression (TTP)
研究概览
简要总结
This is a randomized, prospective and multicenter phase IV clinical trial, which has been designed as a phase III study. One hundred fifty-four women (77 per treatment arm) will be recruited in the study.
详细描述
The main variable is time to disease progression. All patients must be treated with first line of induction chemotherapy, consisting of doxorubicin 75 mg/m2, day 1 every 3 weeks, and docetaxel, 100 mg/m2, day 1 every 3 weeks. Both drugs must be administered sequentially. Patients previously treated with anthracyclines must receive 2 courses of doxorubicin and 4 courses of docetaxel. Otherwise, patients will receive 3 courses of doxorubicin followed by 3 courses of docetaxel.
Patients with complete response, partial response or stable disease are eligible for 2001-01 study.
The investigators assume that maintenance treatment with Caelyx will increase mean time to progression from 10, 46 months (observation) to 17, 43 months. Expected difference in mean time to progression is 6, 97 months (Hazard ratio = 0.6). With an alpha error of 0.01 (unilateral) and power of 80%, 77 patients per arm are needed, 154 patients in total.
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 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Written informed consent.
- •Patients with metastatic breast cancer who have responded to a first line induction chemotherapy treatment.
- •Age: at least 18 years old.
- •Performance status Eastern Cooperative Oncology Group (ECOG) scale 0, 1,
- •Normal cardiac function, confirmed by left ventricular ejection fraction (LVEF).
- •Hematology: leucocytes >= 4 x 10^9/l; neutrophils >= 2.0 x 10^9/l; platelets >= 100 x 10^9/l; hemoglobin <= 10 g/dl.
- •Hepatic function: total bilirubin < 1 upper limit of normal (UNL); aspartate aminotransferase (ASAT) (SGOT) and alanine aminotransferase (ALAT) (SGPT) < 2.5 UNL; alkaline phosphatase < 5 UNL. Patients with ASAT (SGOT) and ALAT (SGPT) > 1.5 UNL and alkaline phosphatase > 2.5 UNL are not eligible.
- •Renal function: creatinine < 175 mmol/l (2 mg/dl); creatinine clearance > 45 ml/min.
排除标准
- •Pregnant or lactating patients.
- •Previous cardiac dysfunction grade II or higher as per New York Heart Association, along with congestive cardiac failure.
- •Hypersensitivity to anthracyclines or Cremophor®.
- •Clinically significant hepatic dysfunction.
- •Current uncontrolled infection.
- •Mental confusion and lack of orientation.
- •Any circumstance precluding an adequate follow-up.
- •Radiotherapy in the previous 4 weeks.
- •Any other concurrent neoplasm, except for basal cell carcinoma or in situ carcinoma.
- •Symptomatic metastasis in the brain.
- •Previous radiotherapy radiating a third of haematopoietic centres.
研究组 & 干预措施
Arm A: PLD
Pegylated liposomal doxorubicin (PLD) after induction chemotherapy in patients with metastatic breast cancer (MBC). Patients without disease progression following first-line induction chemotherapy consisting of three cycles of doxorubicin (75 mg/m2) followed by three cycles of docetaxel (100 mg/m2) both every 21 days, were randomized to PLD (40 mg/m2) every 28 days for six cycles or to observation.
干预措施: Pegylated liposomal doxorubicin (Drug)
结局指标
主要结局
Time to progression (TTP)
时间窗: Through study completion, an average of 1 year
Tumor assessments will be performed until disease progression in order to evaluate the TTP. TTP is defined as the time from the date of the first dose to the first date of objectively determined progressive disease. For patients not known to have objectively-determined progressive disease, TTP will be censored at the date of the last objective progression-free assessment. For patients who receive subsequent systemic anticancer therapy (after discontinuation from the study treatment) prior to objective disease progression, TTP will be censored at the date of last objective progression-free assessment prior to the initiation of postdiscontinuation systemic anticancer therapy.
次要结局
未报告次要终点