PROspective Evaluation of GErmline Mutations, Cancer Outcome and Tissue Biomarkers: A Registry for Patients With Triple Negative Breast Cancer and Germline Mutations
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 22
- 主要终点
- Prevalence of germline mutations (such as BRCA1/2 mutations) in patients with TNBC
研究概览
简要总结
PROGECT is a registry for patients with Triple Negative breast cancer (TNBC) or patients who have an identified germline mutations (such as a mutation on the BRCA1 or BRCA2 genes).
详细描述
This study is being done to collect cancer-related information from patients with triple negative breast cancer and patients with hereditary genetic mutations. This information will help us better understand the link between genetic changes and cancer outcome in patients with triple negative breast cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Triple Negative Breast Cancer
- •ER/PR <10% and HER negative per current ASCO/CAP guidelines
- •Stages I-IV
- •Any age at diagnosis
- •Patient must be within 5 years of diagnosis
- •Eligible regardless of genetic testing status
- •Genetic testing recommended for patients meeting NCCN and Medicare guidelines
- •Germline mutation Carriers
- •Patients with deleterious or uncertain mutations in HBOC genes (BRCA, PTEN, P53, -PALB2 etc) are eligible regardless of type/site of cancer
- •Healthy patients harboring mutations also eligible
- •There is no time limit from the time of diagnosis of cancer and enrollment.
- •Eligible regardless of personal history of cancer
排除标准
- •Triple Negative Breast Cancer -Patient is not within five years of diagnosis
- •Germline mutation Carriers:
- •Patient only carries a HBOC mutation that is classified as "polymorphism" of "favor polymorphism"
结局指标
主要结局
Prevalence of germline mutations (such as BRCA1/2 mutations) in patients with TNBC
时间窗: 5 years
. Predictors of response to neo/adjuvant chemotherapy in patients with TNBC
时间窗: 5 years
Long term Disease free and overall survival rates in TNBC patients treated with different systemic therapies
时间窗: 10 years
次要结局
未报告次要终点
研究者
Priyanka Sharma
Professor of Medicine
University of Kansas