Study Adding Multikinase Inhibitor Sorafenib to Existing Endocrine Therapy in Patients With Advanced Breast Cancer
2015年1月12日 更新者：Suleiman Massarweh
A Phase II Study of Adding the Multikinase Inhibitor Sorafenib (Nexavar) to Existing Endocrine Therapy in Patients With Advanced Breast Cancer
The purpose of this study is to determine the clinical response rate to sorafenib when added to existing endocrine therapy in patients with advanced breast cancer.
研究概览
详细说明
A pilot Phase II study adding sorafenib to endocrine therapy in 11 patients with metastatic estrogen receptor-positive breast cancer was conducted.
Primary end point was response by Response Evaluation Criteria in Solid Tumors (RECIST) after 3 months of sorafenib.
Secondary end points included safety, time to progression and biomarker modulation.
The study closed early owing to slow accrual.
研究类型
介入性
注册 (实际的)
11
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Kentucky
-
Lexington、Kentucky、美国、40536
- University of Kentucky
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- All subjects must be female.
- Age ≥ 18 years old.
- Histologically proven carcinoma of the breast.
- Estrogen receptor and/or Progesterone positive disease.
- Metastatic or locally advanced disease.
- Patients on a preexisting endocrine agent for at least 3 months before enrollment.
Have residual measurable disease after
- maximal response to endocrine therapy or
- no response to endocrine therapy or
- progressive non-visceral disease on endocrine therapy.
- Must be able to provide a tumor block from either the primary or metastatic site, if available.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
- Adequate organ function.
Exclusion Criteria:
- Patients with rapidly progressive disease on endocrine therapy who would otherwise be candidates for chemotherapy.
- Other coexisting malignancies, with the exception of basal cell carcinoma or cervical carcinoma in situ.
- Prior use of anti-angiogenic agents.
- As judged by the investigator, uncontrolled intercurrent illness.
- Known brain metastasis. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis.
- Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.
- Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort.
- Known or suspected allergy to sorafenib or any agent given in the course of this trial.
- A serious non-healing wound or ulcer.
- Evidence or history of bleeding diathesis or coagulopathy.
- Major surgery, open biopsy or significant traumatic injury within the 4 weeks prior to the first dose of the study drug.
- Pulmonary hemorrhage/bleeding event ≥ Common Toxicity Criteria for Adverse Effects (CTCAE) Grade 2 within the 4 weeks prior to the first dose of study drug.
- Pregnancy
- Any condition that impairs patient's ability to swallow whole pills.
- Documented malabsorption problem.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Sorafenib & Endocrine Therapy
|
400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Response Rate
大体时间：12 weeks after treatment & 8 weeks after initial documentation of response
|
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Patients were followed monthly for clinical and toxicity evaluation.
Disease response by RECIST criteria v1.0 was assessed after 3 months by appropriate scans and these were obtained every 2 months thereafter until progression.
|
12 weeks after treatment & 8 weeks after initial documentation of response
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time to Progression
大体时间：continuously
|
continuously
|
|
|
Clinical Benefit Rate
大体时间：24 weeks
|
Clinical benefit rate is defined as complete response, partial response, or stable disease (CR/PR/SD) as measured by Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for a minimum of at least 24 weeks.
|
24 weeks
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2007年10月1日
初级完成 (实际的)
2013年1月1日
研究完成 (实际的)
2015年1月1日
研究注册日期
首次提交
2007年9月3日
首先提交符合 QC 标准的
2007年9月3日
首次发布 (估计)
2007年9月5日
研究记录更新
最后更新发布 (估计)
2015年1月26日
上次提交的符合 QC 标准的更新
2015年1月12日
最后验证
2015年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.