Long Term Followup of Patients Enrolled in MC1137 (BEAUTY)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Mayo Clinic
- 入组人数
- 140
- 试验地点
- 6
- 主要终点
- Identification of mechanisms of treatment resistance and to study new drugs/drug combinations
研究概览
简要总结
This study gathers information and samples for further analysis as part of the BEAUTY study. The purpose of the BEAUTY study was to better understand the reasons why or why not breast cancers respond to standard chemotherapy. Collecting samples of blood and tissue and health and treatment information from patients on the BEAUTY study may help doctors identify changes that make cancer better respond to standard chemotherapy and develop better therapies for the treatment of cancer.
详细描述
PRIMARY OBJECTIVES:
I. Evaluate the association of residual cancer burden and breast cancer disease-free interval.
II. Evaluate the trajectory of circulating tumor cell (CTC) and circulating tumor-deoxyribonucleic acid (ctDNA) over time after breast cancer treatment and the association with breast cancer disease-free interval.
III. Evaluate the association of peripheral blood immune phenotype (circulating immune cell subpopulations as measured by cytometry by time-of-flight [CyTOF]) over time with breast cancer disease-free interval.
IV. Develop and use patient derived xenograft (PDX) models from recurrent breast cancer to identify mechanisms of treatment resistance and to study new drugs/drug combinations.
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
- 否
入选标准
- •REGISTRATION - FOR PATIENTS STILL ALIVE:
- •Enrolled in BEAUTY [MC1137 (NCT02022202)] and did not withdraw consent while enrolled on BEAUTY for either specimen collection or long-term follow-up
- •Able to provide written informed consent
- •REGISTRATION - FOR PATIENTS WHO HAVE DIED:
- •Enrolled in MC1137 and did not withdraw consent while enrolled on BEAUTY for either specimen collection or long-term follow-up
- •Existence of a family member willing to provide consent for use of archived tumor biopsies obtained after enrollment in BEAUTY
排除标准
- 未提供
研究组 & 干预措施
Observational (biospecimen collection, questionnaire)
Patients undergo collection of blood samples throughout the study. Patients may also complete questionnaires and undergo the collection of tissue samples throughout the study.
干预措施: Biospecimen Collection (Procedure)
Observational (biospecimen collection, questionnaire)
Patients undergo collection of blood samples throughout the study. Patients may also complete questionnaires and undergo the collection of tissue samples throughout the study.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Identification of mechanisms of treatment resistance and to study new drugs/drug combinations
时间窗: Up to 10 years following study entry
Will develop and use PDX models from recurrent breast cancer to identify mechanisms of treatment resistance and to study new drugs/drug combinations.
Endogenous antitumor immune response and immune evasion mechanisms
时间窗: Up to 10 years following study entry
Will generate autologous co-culture systems of peripheral blood immune cells and breast cancer tumor cells to study the endogenous antitumor immune response and immune evasion mechanisms
Association of peripheral blood immune phenotype (circulating immune cell subpopulations as measured by CyTOF) over time with breast cancer disease-free interval
时间窗: Up to 10 years following study entry
Trajectory of CTC and ctDNA over time after breast cancer treatment
时间窗: Up to 10 years following study entry
Using RareCyte CTC technology
Association with breast cancer disease-free interval
时间窗: Up to 10 years following study entry
Association of residual cancer burden and breast cancer disease-free interval
时间窗: Up to 10 years following study entry
Changes in the genomic and proteomic landscape over time
时间窗: Up to 10 years following study entry
Will evaluate changes in the genomic and proteomic landscape over time, by sequencing recurrent disease and comparing with sequencing data from the primary tumor.
Assess Spatial immune micro-landscapes of pre-treatment and treated tumors
时间窗: Up to 10 years following study entry
High-plex digital spatial profiling will be used to evaluate immune biomarkers
次要结局
未报告次要终点