Improving Survival for Those With Metastatic Lobular Breast Cancer Through Development of the Multi-center PLUMB Registry-a Prospective Study of LobUlar Metastatic Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Median Overall Survival Rates
研究概览
简要总结
This is a prospective observational registry for patients with invasive lobular carcinoma (ILC) of the breast. After the first 1cohort is enrolled, the collected data will be utilized to develop an ILC specific response assessment tool.
详细描述
Primary Aims:
- To evaluate the feasibility of developing a histologic based registry for participants living with metastatic lobular breast cancer.
- To understand the natural history, treatment patterns, and overall survival in patients with metastatic ILC using modern, real-world data.
Secondary Aims:
- To evaluate the correlation between imaging findings and disease progression.
- To evaluate the correlation between ctDNA and disease progression.
- To develop an ongoing platform for evaluating new imaging tools, tumor markers, and participant recruitment for clinical trials.
Outline:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 confirmed invasive lobular carcinoma. Mixed lobular/ductal cancer is allowed.
- •Age >=18 years
- •Any receptor subtype.
- •Ability to understand a written informed consent document, and the willingness to sign it.
排除标准
- •Stage I-III breast cancer.
- •Lack of lobular histology on tumor biopsy.
- •Other active cancer (prior treated cancer with no current evidence of disease is allowed).
研究组 & 干预措施
Initial Cohort
Up to 12 participants at each evaluation timepoint (approximately every 3-6 months to follow standard of care visits) will have up to 40 mL of blood drawn and distributed into 8 cell-free DNA Streck tubes, for plasma isolation, cell free DNA extraction, and ctDNA analysis. Blood for ctDNA analysis will be collected within +/- 14 days of whole body imaging studies which will occur when patients are scheduled for standard of care whole body imaging.
干预措施: Blood Specimen (Procedure)
结局指标
主要结局
Median Overall Survival Rates
时间窗: Up to 10 years
The overall rate of survival for participants enrolled in the registry will be utilized to develop the ILC specific response assessment tool.
Feasibility of registry
时间窗: Up to 2 years
Feasibility is defined as enrollment of 10-12 patients with metastatic ILC in the first 2 years across all participating sites, and collection of clinical assessments in \>=75% of treating medical oncologists
Median Progression Free Survival Rate
时间窗: Up to 10 years
The median Progression-free survival rate (PFS) for participants enrolled in the registry will be utilized to develop the ILC specific response assessment tool.
Proportion of patients with measurable versus unmeasurable disease
时间窗: Up to 10 years
Proportion of patients with measurable disease versus unmeasurable disease using Response Evaluation Criteria in Solid Tumors (RECIST) will be reported for each line of treatment as determined by their oncologist.
次要结局
- Number of novel imaging tools(Up to 10 years)
- Number of new tumor markers introduced(Up to 10 years)
- Number of participants enrolled in clinical trials(Up to 10 years)
- Proportion of participants who are currently taking estrogen receptor modulators or degraders(Up to 10 years)
- Mean Change in Circulating tumor DNA (ctDNA)(Up to 10 years)