A Phase II Study of Adding the Multikinase Inhibitor Sorafenib (Nexavar) to Existing Endocrine Therapy in Patients With Advanced Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Response Rate
研究概览
简要总结
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.
详细描述
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
- •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-
- •Adequate organ function.
排除标准
- •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.
研究组 & 干预措施
Sorafenib & Endocrine Therapy
Sorafenib & Endocrine Therapy
干预措施: sorafenib (Drug)
结局指标
主要结局
Response Rate
时间窗: 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.
次要结局
- Time to Progression(continuously)
- Clinical Benefit Rate(24 weeks)
研究者
Suleiman Massarweh
Clinical Faculty, Internal Medicine / Oncology
University of Kentucky