Molecular Mechanisms of Clinical Resistance to Targeted Therapy Among Patients With Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 269
- 试验地点
- 7
- 主要终点
- To look for mutations in druggable oncogenic pathways in tumors progressing on anti-HER2 therapy or hormonal therapy
研究概览
简要总结
The purpose of this study is to learn why certain drugs stop working in patients.In lab studies, tumors become resistant in several ways. Specific molecules seem to change and this may be why therapy stops working. However, we do not know if the same molecules change in patients. This study is being done to see if they do change. If we learn more about how patients become resistant, we may be able to offer better treatment in the future.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients:
- •Diagnosed with breast cancer.
- •Patient must be able to consent to a biopsy
- •Patient must be able to safely undergo a secondary biopsy, if needed.
- •Patients who previously received treatment with anti-HER2 therapy (including trastuzumab, pertuzumab, TDM1, lapatinib, neratibin, or DS8201) as part of adjuvant chemotherapy and now have progressive or recurrent breast cancer or, patients who previously (or currently) received anti-HER2 therapy as part of a regimen for metastatic breast cancer and subsequently experienced.
- •Evidence of disease progression or recurrence after prior therapy (e.g. radiologic progression by RECIST criteria or new metastasis).
- •Prior tumor biopsy (may be original) defined as HER2+ by amplification by FISH (>1.9 gene copy number) or IHC 3+.
- •Patients who previously received treatment with hormonal therapy (including aromatase inhibitors or SERMs or SERDs) as a part of adjuvant therapy and now have progressive or recurrent breast cancer or patients who previously (or currently) receive hormonal therapy as part of a regimen for metastatic breast cancer and subsequently experienced evidence of disease progression.
- •Patients not eligible for Cohorts 1 or 2.
排除标准
- •Patients who are unable to consent to a biopsy.
- •Patients for whom a repeat biopsy would be medically unsafe
结局指标
主要结局
To look for mutations in druggable oncogenic pathways in tumors progressing on anti-HER2 therapy or hormonal therapy
时间窗: 3 years
To characterize the activity of the PI3K signaling pathway in progressive breast tumors using proteomic methods
时间窗: 3 years
To develop new laboratory models of treatment refractory breast cancer from human tumor specimens
时间窗: 3 years
次要结局
- To characterize the genetic heterogeneity of progressive, metastatic tumors using next generation sequencing(3 years)
- To look for mutations in druggable oncogenic pathways in tumor progressing on breast cancer targeted therapies(3 years)
- To evaluate dynamic proteomic changes in response to inhibition of the RTK/PI3K/ATK/mTOR pathway.(3 years)