Evaluating Minimal Residual Disease (MRD) Through Longitudinal Circulating Tumor DNA (ctDNA) Profiling in Breast Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Tempus AI
- 入组人数
- 900
- 试验地点
- 16
- 主要终点
- Invasive Disease-Free Survival (iDFS) stratified by MRD status during neoadjuvant, post-surgery landmark, post definitive treatment (surveillance), and long-term follow-up
研究概览
简要总结
For patients with breast cancer, it's important to find any remaining cancer cells after they've had their main treatment. Even a few cells, called minimal residual disease (MRD), can lead to the cancer coming back later.
A way to find these cells is by looking for tiny bits of cancer DNA that are shed into the blood. This is called circulating tumor DNA (ctDNA). A simple blood test, often called a liquid biopsy, can detect this ctDNA. This research aims to see if finding this cancer DNA in the blood can help predict if a patient's cancer will return. It also may help find out if the treatment is working.
Ultimately, the results of this research may help doctors better manage breast cancer and develop new and improved tests and treatments.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All Cohorts:
- •Willing and able to participate in the research and provide biospecimens
- •Willing and able to provide informed consent
- •Must be diagnosed with breast cancer
- •Cohort 1: Neoadjuvant Treatment Cohort 1A: Newly Diagnosed, High Risk HR+,HER2-
- •A known or suspected HR+, HER2- breast cancer treated with curative intent (Stage II to III disease)
- •Patients are considered at high risk of recurrence, defined as 4 or more positive axillary lymph nodes (ALNs), or between 1-3 positive ALNs and either grade 3 disease or tumor size of 5 cm or larger.
- •Cohort 1B: HER2+
- •A known or suspected HER2+ breast cancer treated with curative intent (Stage II to III disease). Inclusive of HR+ or HR- patients.
- •Cohort 1C: Triple Negative Breast Cancer
- •1. A known or suspected triple negative breast cancer treated with curative intent (Stage I to III disease).
- •Cohort 2: Adjuvant Therapy / Surveillance Cohort 2A: Newly Diagnosed HR+,HER2-
- •A known or suspected HR+, HER2- breast cancer treated with curative intent (Stage II to III disease)
- •Patients are considered at high risk of recurrence, defined as 4 or more positive axillary lymph nodes (ALNs), or between 1-3 positive ALNs and either grade 3 disease or tumor size of 5 cm or larger.
- •Have undergone curative intent surgery with no clinical evidence of disease.
- •Cohort 2B: HER2+
- •A known or suspected HER2+ breast cancer treated with curative intent (Stage II to III disease)
- •Have undergone curative intent surgery with no clinical evidence of disease.
- •Cohort 2C: Triple Negative Breast Cancer
- •A known or suspected triple negative breast cancer treated with curative intent (Stage I to III disease)
- •Have undergone curative intent surgery with no clinical evidence of disease.
- •Cohort 3: 5-Years Post-Diagnosis Surveillance (NED)
- •A known HR+, HER2- breast cancer treated with curative intent (Stage II to III disease).
- •No Evidence of Disease (NED) ≥ 5 years from initial diagnosis.
- •Patients are considered at high risk of recurrence, defined as 4 or more positive axillary lymph nodes (ALNs), or between 1-3 positive ALNs and either grade 3 disease or tumor size of 5 cm or larger.
排除标准
- •Not willing or able to adhere with the study procedures
- •Active secondary malignancy
- •Diagnosis of a malignancy within 3 years of breast cancer diagnosis Note: Ductal carcinoma in situ (DCIS, ipsilateral or contralateral) within 3 years is not excluded.
研究组 & 干预措施
Cohort 2: Adjuvant Therapy / Surveillance
There are no interventions in this observational study. Cohort 2 includes participants who will receive adjuvant therapy after surgery.
干预措施: There are no interventions in this observational study. (Other)
Cohort 3: 5 Years Post-Diagnosis Surveillance
There are no interventions in this observational study. Cohort 3 includes participants who have no evidence of disease for at least 5 years post diagnosis.
干预措施: There are no interventions in this observational study. (Other)
Cohort 1: Neoadjuvant Therapy
There are no interventions in this observational study. Cohort 1 includes participants who will receive neoadjuvant treatment prior to surgery.
干预措施: There are no interventions in this observational study. (Other)
结局指标
主要结局
Invasive Disease-Free Survival (iDFS) stratified by MRD status during neoadjuvant, post-surgery landmark, post definitive treatment (surveillance), and long-term follow-up
时间窗: 5 years
次要结局
- Distant disease free survival rates stratified by MRD status during neoadjuvant treatment(5 years)
- Overall Survival rates stratified by MRD status during neoadjuvant treatment, post-surgery landmark, post definitive treatment (surveillance), and long-term follow-up(5 years)
- Pathologic Complete Response (pCR) or Residual Cancer Burden (RCB) rate stratified by MRD status at post-surgery landmark(5 years)
- Time from First Positive MRD Sample to Recurrence(5 years)