PREDICT-RD: Postoperative Molecular Residual Disease by ctDNA Surveillance in TNBC With Residual Disease
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- The proportion of triple negative breast cancer (TNBC) with molecular residual disease (MRD)
研究概览
简要总结
This is a Phase II, interventional, prospective, single-arm, multi-center study that will enroll patients with stage II/III triple negative breast cancer (TNBC) who have residual cancer burden (RCB) II/III after conventional neoadjuvant chemo-immunotherapy followed by surgery. Technological advances in ctDNA assays have improved both the sensitivity and reliability of molecular residual disease (MRD) detection to enable real-time measurement with clinical-grade assays.
The primary objective of this study will be to evaluate ctDNA-based MRD status in high-risk, early-stage TNBC patients by defining the proportion of TNBC patients with MRD-only recurrence (ctDNA positive without radiographically measurable recurrence) during post-surgery surveillance. The secondary objectives will evaluate the safety, preliminary efficacy, and survival outcomes of using Dato-DXd in participants with MRD-only TNBC.
Dato-DXd is an investigational antibody-drug conjugate (monoclonal antibody specific for TROP2 and a topoisomerase I (Topo-1) inhibitor) that has demonstrated promising efficacy in TNBC patients with a manageable safety profile.
详细描述
Despite treatment advances, patients with II/III triple negative breast cancer (TNBC) residual disease post-neoadjuvant therapy, particularly patients with higher residual cancer burden (RCB II/III), remain at high risk for developing recurrence. Furthermore, early detection of relapse risk, when the residual disease burden is micrometastatic (defined here as undetectable by standard cross-sectional imaging), provides a chance for disease eradication whereas macrometastatic disease (i.e., detectable on standard cross-sectional imaging) is generally considered to be non-curable.
There are no standard of care (SOC) surveillance strategies for early detection of micrometastatic disease in high-risk TNBC beyond clinical monitoring. Detecting molecular residual disease (MRD) is a promising approach to identifying patients at increased risk of recurrence after definitive therapy, who may benefit from the escalation of their treatment and remain potentially curable with effective systemic therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Written informed consent was obtained to participate in the study, and HIPAA authorization for the release of personal health information.
- •Participant is willing and able to comply with study procedures based on the judgment of the investigator.
- •Age ≥ 18 years at the time of consent.
- •Histological confirmation of TNBC defined by ER/PR <10%, HER2 0-1+ by IHC or 2+ by IHC and fluorescence in situ hybridization (FISH) negative.
- •Stage II/III TNBC treated with neoadjuvant systemic therapy AND have residual disease defined as RCB II/III at time of surgery.
- •Baseline staging scans at the discretion of the treating physician and demonstrate no evidence of metastatic disease.
- •The participant must have archival diagnostic tissue and/or surgical resection tissue Available.
- •Participants are willing and able to comply with study procedures based on the judgment of the investigator.
排除标准
- •Participants are pregnant or breastfeeding.
研究组 & 干预措施
Patients with higher residual cancer burden
Participants with stage II/III triple negative breast cancer (TNBC) and residual disease post-neoadjuvant therapy, particularly patients with higher residual cancer burden (RCB II/III), remain at high risk for developing recurrence.
干预措施: Datopotamab deruxtecan (Drug)
Patients with higher residual cancer burden
Participants with stage II/III triple negative breast cancer (TNBC) and residual disease post-neoadjuvant therapy, particularly patients with higher residual cancer burden (RCB II/III), remain at high risk for developing recurrence.
干预措施: Circulating tumor DNA (ctDNA) testing (Diagnostic Test)
结局指标
主要结局
The proportion of triple negative breast cancer (TNBC) with molecular residual disease (MRD)
时间窗: Up to 3 years after registration
The number of participants with triple negative breast cancer (TNBC) with molecular residual disease (MRD) only recurrence, which is defined as ctDNA positivity without radiographically measurable recurrence, during post-surgery surveillance.
次要结局
- The time between Circulating tumor DNA (ctDNA) positivity and clinically proven relapse(Up to 3 years after registration)
- Duration of Circulating tumor DNA (ctDNA) clearance(Up to 3 years after registration)
- Circulating tumor DNA (ctDNA) clearance with Dato-DXd(Up to 3 years after registration)
- Toxicity of Dato-DXd(Up to 3 years after registration)
- Recurrence Free Survival (RFS) for ctDNA-positive and ctDNA-negative disease.(Up to 3 years after registration)
- Recurrence Free Survival (RFS) - Dato-DXd(Up to 3 years after registration)
- Overall Survival (OS) - ctDNA-positive and ctDNA and negative disease.(Up to 3 years after registration)
- Overall Survival (OS) - for ctDNA-positive and ctDNA-negative disease.(Up to 3 years after registration)