A Pilot Randomized Phase II Study of Adjuvant Administration of Trastuzumab (HERCEPTIN) Versus Observation After the Completion of Adjuvant Chemotherapy and Radiotherapy in Patients With Stage I-III Breast Cancer Who Have Detectable Disseminated and/or Circulating Tumor Cells (DTCs and/or CTCs) in the Bone Marrow or/and the Peripheral Blood Before or/and After the Completion of Adjuvant Treatment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Compare the disease-free interval of patients with early-stage breast cancer
研究概览
简要总结
Epithelial tumor cells can be detected in the bone marrow and/or the peripheral blood [disseminated and circulating tumor cells, (DTCs) and (CTCs) respectively] of otherwise metastases-free patients with early breast cancer. Several studies have shown that the presence of these cells is an independent factor associated with an increased incidence of early disease relapse and disease-related death. In almost 50% of the patients, adjuvant chemotherapy cannot eliminate these occult tumor cells and this is also associated with a higher probability of early relapse and death. In 60-70% of the patients, DTCs and/or CTCs express the HER2/c-neu molecule and one or two administrations of their monoclonal antibody trastuzumab (HERCEPTIN) could eliminate these cells for a period ranging from 3-12 months.
详细描述
This pilot trial will compare the efficacy of the anti-HER2/erb-B2 monoclonal antibody trastuzumab (HERCEPTIN) given after the completion of the standard adjuvant chemotherapy and radiotherapy versus observation in patients with stage I-III operable breast cancer who have detectable cytokeratin-19 (CK-19) mRNA-positive tumor cells in the bone marrow or the peripheral blood before and/or after the adjuvant 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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age >= 18 years.
- •Performance status (World Health Organization [WHO]) < 3
- •Adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count > 100000/mm^3, hemoglobin > 9 gr/mm^3)
- •Adequate liver (bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times upper limit of normal) and renal function ( creatinine < 2 mg/dl)
- •Adequate cardiac function (left ventricular ejection fraction [LVEF] > 50%).
- •Informed consent
- •Histologically or cytologically confirmed breast adenocarcinoma
- •Prior surgical excision of the primary breast tumor
- •Prior completion of standard adjuvant chemotherapy and/or radiotherapy
- •Locally advanced disease after the completion of neo-adjuvant chemotherapy, surgical excision and radiotherapy provided that there was no evidence of local or metastatic disease
- •Absence of any clinical or laboratory evidence of metastatic disease
- •Detection of CTCs and/or DTCs (when it could be feasible) before the initiation and/or after the completion of adjuvant chemotherapy and/or radiotherapy
- •Expression of HER2/c-neu on the primary tumor is not mandatory
排除标准
- •Other invasive malignancy within the past 5 years except nonmelanoma skin cancer
- •Other concurrent uncontrolled illness
- •Psychiatric illness or social situation that would preclude study compliance
- •Pregnant or nursing
- •Positive pregnancy test
- •History of allergic reaction attributed to trastuzumab (HERCEPTIN)
研究组 & 干预措施
1
Her
干预措施: Trastuzumab (Drug)
结局指标
主要结局
Compare the disease-free interval of patients with early-stage breast cancer
时间窗: 3 years
次要结局
- Elimination of CK-19 mRNA-positive CTCs.(Assessment of CK-19 mRNA CTCs every 3 months)