A Phase II Study of Combined VEGF Inhibitor (Bevacizumab + Sorafenib) in Patients With Metastatic Breast Cancer: Hoosier Oncology Group BRE06-109
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 18
- 试验地点
- 10
- 主要终点
- Progression-Free Survival
研究概览
简要总结
Prior clinical trials involving bevacizumab and sorafenib have demonstrated single agent activity in previously treated advanced breast cancer. This trial will test combined VEGF inhibition with sorafenib and bevacizumab in less heavily pre-treated patients with advanced breast cancer.
详细描述
OUTLINE: This is a multi-center study.
Sorafenib 200mg po daily Bevacizumab 5mg/kg every other week
1 Cycle = 4 weeks Imaging every third cycle
Acceptable toxicity and non-PD = Protocol therapy will continue Un-acceptable toxicity or PD = Protocol therapy will be discontinued
ECOG Performance Status 0-1
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
- All
- 接受健康志愿者
- 否
入选标准
- •Histologic or cytologic diagnosis of breast cancer with evidence of metastatic disease. NOTE: Patients with Her-2 positive (3+ by IHC or gene amplification by FISH) are eligible only if they have had prior trastuzumab therapy.
- •Must have measurable or non-measurable lesions as defined by the Response Evaluation Criteria in Solid Tumors (RECIST).
- •Two or fewer prior chemotherapy regimens in any disease setting. NOTE: All adjuvant and neoadjuvant chemotherapy will be considered one regimen. NOTE: Prior hormonal therapy for metastatic disease is allowed. NOTE: Prior radiation therapy is allowed as long as the irradiated area is not the only source of evaluable disease.
- •Age > 18 years at the time of consent.
- •Written informed consent and HIPAA authorization for release of personal health information.
- •Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 8 weeks after treatment discontinuation.
- •Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy.
- •Ability to comply with study and/or follow-up procedures.
排除标准
- •No prior therapy with bevacizumab, sorafenib or any other known VEGF inhibitors.
- •No known hypersensitivity to any component of the study drugs.
- •No other forms of cancer therapy including radiation, chemotherapy and hormonal therapy within 21 days prior to being registered for protocol therapy.
- •No history or radiologic evidence of CNS metastases including previously treated, resected, or asymptomatic brain lesions or leptominigeal involvement. A head CT or MRI must be obtained within 28 days prior to being registered for protocol therapy.
- •No other participation in another clinical drug study within 28 days prior to being registered for protocol therapy.
- •No known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C
- •No major surgical procedure within 28 days prior to being registered for protocol therapy or anticipation of need for major surgical procedure during the course of the study. Placement of a vascular access device and breast biopsy will not be considered major surgery.
- •No minor surgical procedure within 7 days prior to being registered for protocol therapy.
- •No known history of cerebrovascular disease including TIA, stroke or subarachnoid hemorrhage.
- •No known history of ischemic bowel.
- •No known history of deep venous thrombosis or pulmonary embolism.
- •No history of hypertensive crisis or hypertensive encephalopathy.
- •No non-healing wound or fracture.
- •No active infection requiring parenteral antibiotics.
- •No other hemorrhage/bleeding event ≥ CTCAE grade 3 within 28 days prior to being registered for protocol therapy.
研究组 & 干预措施
Single Arm A
Sorafenib 200mg po daily, Bevacizumab 5mg/kg every other week, 1 Cycle = 4 weeks. Imaging every third cycle
干预措施: Sorafenib (Drug)
Single Arm A
Sorafenib 200mg po daily, Bevacizumab 5mg/kg every other week, 1 Cycle = 4 weeks. Imaging every third cycle
干预措施: Bevacizumab (Drug)
Single Arm A
Sorafenib 200mg po daily, Bevacizumab 5mg/kg every other week, 1 Cycle = 4 weeks. Imaging every third cycle
干预措施: Imaging (Other)
结局指标
主要结局
Progression-Free Survival
时间窗: From the start of the treatment until the criteria for disease progression is met (or death occurs) maximum of 24 months
The primary objective was to assess the Progression-Free Survival of sorafenib combined with bevacizumab in patients with metastatic breast cancer. Progression is defined by RECIST as a 20% increase in the sum of the longest diameters of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) or by the appearance of a new lesion.
次要结局
- Assess the Clinical Benefit Response: the Proportion of Patients With Clinical Benefit (CR+PR+SD > 6 Months Duration) Will be Assessed at the Completion of the Study.(6 months)
- Assess the Overall Response Rate.(24 months)
- Determine the Adverse Event Profile of Sorafenib Combined With Bevacizumab in This Patient Population.(24 months)
研究者
Robin Zon, MD
Sponsor-Investigator
Hoosier Cancer Research Network