A Multicenter Randomized Phase II Study of First Line Treatment With Sequential Administration of Docetaxel, Carboplatin and Herceptin Versus the Administration of Vinorelbine and Herceptin Combination in HER-2 Positive Patients With Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 88
- 试验地点
- 10
- 主要终点
- Time to progression between the two treatment arms
研究概览
简要总结
This trial will compare the efficacy of sequential administration of Docetaxel, Carboplatin and Herceptin versus the administration of Vinorelbine and Herceptin combination as first line treatment in HER-2 positive patients with metastatic breast cancer.
详细描述
Herceptin, a humanized monoclonal antibody directed against the extracellular domain of the transmembrane glycoprotein HER2/neu (c-erbB-2), is a valuable option in the treatment of women with HER2-positive metastatic breast cancer. The combination of Herceptin and chemotherapy yielded significantly better results than chemotherapy alone in response, time to progression, and survival time. Whether the combination of Docetaxel, Carboplatin and Herceptin versus the administration of Vinorelbine and Herceptin combination in HER-2 positive patients with metastatic breast cancer is preferable is not yet known.
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
- •Performance status (WHO) 0-2
- •Histologically confirmed metastatic breast adenocarcinoma (stage IV) without any prior chemotherapy received
- •HER-2 overexpression 2+ or 3+ using IHC or FISH +
- •Measurable disease not in a prior irradiation field (no other concurrent chemotherapy agents)
- •No more than 25% of myeloproductive bone marrow irradiated (more than 4 weeks since prior radiotherapy and recovered)
- •More than 6 months since prior adjuvant or neoadjuvant chemotherapy and recovered
- •No prior first line chemotherapy for metastatic disease
- •Endocrine therapy is allowed as adjuvant or first line treatment for metastatic disease
- •Paraffin block from the primary tumor available in the research lab
- •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 < 2mg/dl)
- •Adequate cardiac function (LVEF > 50%)
- •Informed consent
排除标准
- •Pregnant or nursing
- •Concurrent agents ketoconazole, macrolide antibiotics, zidovudine which may induce P-450 cytochrome
- •Positive pregnancy test
- •Motor or sensory neuropathy > grade 1 according to NCIC Τoxicity Criteria
- •Patients with brain metastatic disease who has not been irradiated or uncontrolled brain metastatic disease after irradiation
- •History of allergic reaction attributed to docetaxel
- •Psychiatric illness or social situation that would preclude study compliance
- •Other concurrent uncontrolled illness.
- •Other invasive malignancy within the past 5 years except cured basal cell skin carcinoma and cervical carcinoma in situ
研究组 & 干预措施
1
Docetaxel + Carboplatin + Herceptin (D/Carbo/Her)
干预措施: Docetaxel (Drug)
1
Docetaxel + Carboplatin + Herceptin (D/Carbo/Her)
干预措施: Carboplatin (Drug)
1
Docetaxel + Carboplatin + Herceptin (D/Carbo/Her)
干预措施: Herceptin (Drug)
2
Vinorelbine + Herceptin (VHer)
干预措施: Herceptin (Drug)
2
Vinorelbine + Herceptin (VHer)
干预措施: Vinorelbine (Drug)
结局指标
主要结局
Time to progression between the two treatment arms
时间窗: 1 year
次要结局
- Toxicity profile(During the time of chemotherpy)
- Overall survival(1 year)