NCT00138125终止2 期
Phase II Randomized Trial of Faslodex and Herceptin, Alone and Combined, in the First - Line Treatment of Hormone Receptor-Positive, HER-2/Neu-Overexpressing Metastatic Breast Cancer
Translational Oncology Research International2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2005年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Progression-free Survival
研究概览
简要总结
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant may fight breast cancer by lowering the amount of estrogen the body makes. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving fulvestrant together with trastuzumab is more effective than giving fulvestrant or trastuzumab alone in treating breast cancer.
PURPOSE: This randomized phase II trial is studying how well fulvestrant and/or trastuzumab works as first-line therapy in treating postmenopausal women with stage IV breast cancer.
详细描述
OBJECTIVES:
Primary
- Compare the overall objective response rate in postmenopausal women with estrogen receptor (ER)- and/or progesterone receptor (PR)-positive, HER2/neu-overexpressing stage IV breast cancer treated with first-line therapy comprising fulvestrant and/or trastuzumab (Herceptin®).
Secondary
- Compare the duration of response in patients treated with these regimens.
- Compare overall survival of patients treated with these regimens.
- Compare the antitumor activity of these regimens, in terms of time to disease progression, in these patients.
- Compare the clinical benefit of these regimens in these patients.
- Determine the safety and toxicity of these regimens in these patients.
- Correlate HER2/neu expression and ER and/or PR expression with response in patients treated with these regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patient, postmenopausal, defined as a woman fulfilling any one of the following criteria:
- •Age 60 years or older
- •Age 45 years or older with amenorrhea for > 12 months with an intact uterus
- •Follicle-stimulating hormone and estradiol levels within post-menopausal range
- •Having undergone a bilateral oophorectomy
- •Histologically or cytologically proven adenocarcinoma of the breast
- •Subjects must have archived rumor tissue available to compare the clinical response with tumor expression of biomarkers, such as HER-2, ER and PR; archived tissue will be used to confirm HER-2, ER and PR status, but results will not be used to determine subject eligibility for the study
- •HER2-positive disease
- •ER-positive and/or PR-positive disease
- •ECOG performance status 0-2
- •Life expectancy > 24 weeks
- •Left ventricular ejection fraction > lower limit of normal
- •No prior chemotherapy, endocrine therapy, Herceptin, or other biologic or investigational therapy for metastatic breast cancer
- •No more than two prior endocrine agents in the adjuvant setting as single- or sequential-therapy is permitted, but no prior Faslodex therapy is permitted. A 1-month treatment-free period is required prior to receiving the first dose of trial treatments
- •Prior adjuvant chemotherapy is permitted
- •Prior adjuvant Herceptin permitted
- •At least 1 month since prior surgery, radiotherapy, or endocrine therapy, with complete recovery from the effects of these interventions
- •Patients must have ended any hormone replacement therapy at least 1 month prior to receiving the first dose of trial therapy
- •Patients treated with bisphosphonates may enroll, with heir bone lesions only assessable for disease progression
- •Patient is accessible and willing to comply with treatment and follow-up
- •Patient is willing to provide written informed consent prior to the performance of any study-related procedures
- •Required laboratory values:
- •Absolute neutrophil count > 1.5 x 10^9/L
- •Hemoglobin > 10g/dL
- •Platelet count > 100 x 10^9/L
- •Creatinine < 2.0 mg/dL
- •Total bilirubin < 1.5 x upper limit of normal
- •AST and ALT < 2.5 x ULN
排除标准
- •Prior chemotherapy, hormonal therapy, Herceptin or other investigational therapy for metastatic breast cancer
- •Prior treatment with Faslodex
- •Concurrent therapy with any other non-protocol anti-cancer therapy
- •Current or prior history of brain metastases
- •History of any other malignancy within the past 5 years, with the exception of non-melanoma skin cancer or carcinoma-in-situ of the cervix
- •Clinically significant cardiovascular disease, New York Heart Association Class II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication
- •Prior exposure of > 360 mg/m2 doxorubicin or liposomal doxorubicin, > 120 mg/m2 mitoxantrone, > 90 mg/m2 idarubicin, or > 720 mg/m2 epirubicin
- •Active, uncontrolled infection requiring parenteral antimicrobials
- •The presence of any other medical or psychiatric disorder that, in the opinion of the treating physician, would contraindicate the use of the drugs in this protocol or place the subject at undue risk for treatment complications
- •Inability to comply with the study protocol or follow-up procedures
- •Known hypersensitivity to any of the drugs used in this protocol or to active or inactive excipients of Faslodex
- •History of bleeding diasthesis
- •Long-term anticoagulant therapy other than anti-platelet therapy, such as with warfarin
研究组 & 干预措施
Arm I
Experimental
see intervention description for details
干预措施: Faslodex (Drug)
Arm I
Experimental
see intervention description for details
干预措施: Herceptin (Biological)
结局指标
主要结局
Progression-free Survival
时间窗: 5 years
Of the two treated patients on this trial, the records show that one patient who received Herceptin only completed 3 cycles of therapy, while the second patient who received Herceptin in combination with Faslodex completed 9 cycles of therapy. The last survival data collected from October to November 2008 showed that these two participants were alive at that time.
次要结局
- Overall Objective Response Rate(5 years)
- Overall Survival(5 years)
- Clinical Benefit (CR + PR + SD > 6 Months)(5 years)
- Time to Tumor Progression(5 years)
- Duration of Response(5 years)
研究者
研究点 (2)
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