A Two Arm Pilot Study Utilizing Molecular Profiling to Find Potential Targets and Influence Treatments for Patients With Metastatic Breast Cancer or Advanced Gynecological Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Progression-free survival
研究概览
简要总结
The primary objective is to examine the impact on progression-free survival of targeted therapy for breast cancer suggested by proteomic and genomic profiling.
详细描述
To explore the impact of targeted therapy for breast cancer suggested by proteomic and genomic profiling using RPMA, targeted resequencing, IHC analysis, WGS, RNA-seq, and Exome sequencing on progression-free survival. When a molecular target cannot be identified, the patient will be treated with a therapy selected on an empirical basis by the investigator/treating physician at the individual site and will be followed for survival status. Only available, FDA-approved agents will be used.
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
- •Life expectancy of >3 months
- •Diagnosis of metastatic breast cancer or an advanced gynecological malignancy with measurable disease
- •Age greater than or equal to 18 years
- •ECOG performance status of 0-1
- •Able to undergo two biopsies to obtain tissue with first biopsy required and second biopsy optional
- •Have failed or unable to tolerate previous treatment regimen
- •Adequate organ and bone marrow function as defined by ANC ≥ 1.5 x 109/L; Hgb 9 g/dL; platelets greater than 100 x 109/L; creatinine ≤ 1.5 mg/dL; bilirubin ≤ 2.5 x ULN; AST and ALT ≤ 2.5 x ULN (or ≤ 5 x ULN if due to underlying liver metastases); INR ≤ 1.5 x ULN (except in the case of anticoagulation therapy)
排除标准
- •Metastatic lesions that are not accessible to biopsy
- •Symptomatic CNS metastasis
- •Previous history of another malignancy within 5 years of study entry
- •Uncontrolled concurrent illness
- •Known HIV, HBB, and/or HCV infection
- •Pregnant or breast feeding or childbearing potential and not using adequate birth control
研究组 & 干预措施
Targeted Therapy
Those who will receive targeted therapy based on their genetic profiling
干预措施: Genetic profiling (Genetic)
结局指标
主要结局
Progression-free survival
时间窗: 4 months
Progression-free survival will be defined as the interval between the first dose of therapy and the occurrence of disease progression (fatal or non-fatal). Disease status will be assessed every 7 +/- 1 week until progression or time of treatment discontinuation, whichever is later. If progression is not observed at the end of therapy, patients will be assessed every 3 months until progression or further anti-cancer therapy.
次要结局
- Tumor assessment(4 months)