A Phase II Study of XL184 (Cabozantinib) for Metastatic Triple-Negative Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 3
- 主要终点
- Objective Response Rate
研究概览
简要总结
In this research study, we are looking at the anti-tumor effects of Cabozantinib (XL184) in metastatic breast cancer. Data suggest that MET expression and activation are important for initiation and progression of triple-negative breast cancer (TNBC). We evaluated the efficacy of cabozantinib (XL184), a novel inhibitor of multiple receptor tyrosine kinases, including MET and VEGFR2, in patients with metastatic TNBC.
详细描述
OBJECTIVES:
Primary
* To evaluate the activity of cabozantinib, as defined by objective response rate in patients with triple-negative metastatic breast cancer
Secondary
- To evaluate progression free survival
- To evaluate c-Met and phospho c-Met expression in archival tumor tissue
- To evaluate the incidence of c-Met amplified circulating tumor cells at baseline
- To evaluate potential plasma biomarkers of cabozantinib
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
- •Histologically or cytologically confirmed invasive breast cancer with stage IV disease
- •Primary tumor and/or metastasis must be ER-negative, PR-negative and HER2-negative
- •May have received 0-3 prior chemotherapeutic regimens for metastatic breast cancer. Must be off treatment for at least 21 days prior to enrollment
- •Must have discontinued all biologic therapy at least 14 days before enrollment
- •May have received prior radiation therapy in the early stage or metastatic setting, but must have completed treatment at least 14 days prior to enrollment
- •Must agree to use medically acceptable methods of contraception
- •Confirmed availability of formalin-fixed, paraffin-embedded tumor tissue
- •Able to swallow tablets
排除标准
- •Pregnant or breastfeeding
- •Received another investigational agent within 14 days prior to enrollment
- •Received prior c-Met inhibitor
- •Known brain metastases that are untreated, symptomatic or require therapy to control symptoms
- •Psychiatric illness or social situation that could limit ability to comply with study requirements
- •Require concomitant treatment in therapeutic doses with anticoagulants or antiplatelet agents
- •Diagnosis of another malignancy requiring systemic treatment within the last two years (except non-melanoma skin cancer or in-situ carcinoma of the cervix)
- •Known to be positive for HIV
- •Active infection requiring IV antibiotics at Day 1 of cycle 1
- •Uncontrolled, significant intercurrent illness
- •Requires chronic concomitant treatment of a strong CYP3A4 inducer
- •tumor in contact with, invading or encasing major blood vessels
- •Have experienced clinically significant gastrointestinal bleeding within 6 months, hemoptysis of more than 0.5 teaspoon of red blood within 3 months or other signs indicative of pulmonary hemorrhage within 3 months of enrollment
研究组 & 干预措施
Cabozantinib
Cabozantinib was given at a dose of 60 mg orally once per day for 21 day cycles. Treatment continued in the absence of disease progression or unacceptable toxicity.
干预措施: Cabozantinib (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: Disease was evaluated radiologically at baseline, week 6 and every 9 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 3 cycles range (1-17).
The objective response rate (ORR) was defined as achieving complete response (CR) or partial response (PR) on treatment based on RECIST1.1 criteria. For target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. Confirmatory scans were required 3 weeks following initial documentation.
次要结局
- Progression Free Survival(Disease was evaluated radiologically at baseline, week 6 and every 9 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 3 cycles range (1-17).)
研究者
Sara Tolaney
Prinicipal Investigator
Dana-Farber Cancer Institute