NCT06401421招募中不适用
EXActDNA-003 / NSABP B-64: Breast Cancer Clinical Validation Study to Predict Recurrence of High-Risk Early Breast Cancer Treated With Neoadjuvant Therapy Using a Bespoke Circulating Tumor DNA Assay to Detect Molecular Residual Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,800
- 试验地点
- 53
- 主要终点
- Distant Recurrence Free Interval (dRFI)
研究概览
简要总结
The EXActDNA-003 study will prospectively enroll participants who are planning to undergo chemotherapy for high-risk, early breast cancer, who are willing to provide tissue and blood specimens for circulating tumor DNA (ctDNA) analysis.
Participants will be followed for up to 5.5 years.
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
- •The participant or a legally authorized representative must provide study-specific informed consent prior to study entry.
- •The participant must be ≥ 18 years of age.
- •ECOG performance status 0 or
- •Histologically confirmed invasive carcinoma of the breast.
- •Planned neoadjuvant therapy which includes cytotoxic chemotherapy.
- •Tumor size ≥ 2.1 cm in greatest diameter.
- •Unifocal or multifocal cancer documented to be the same histologic clinical subtype.
- •Clinically node positive or if node negative, any one of the following:
- •TNBC or HER2+ subtype
- •HR+/HER2-negative with at least one of the following:
- •i. High tumor grade (G3) ii. Ki67 index of 20% or higher iii. High genomic risk (Oncotype DX® (ODX) Breast Recurrence Score of > 25, MammaPrint® High, etc.)
- •Willing and able to comply with the study requirements, which includes the collection of a total of 34 cc (2.5 Tablespoons) of blood for each research blood draw.
- •Available residual tissue from diagnostic biopsy from the breast or an involved ipsilateral lymph node for submission to create a bespoke ctDNA assay.
排除标准
- •Definitive clinical or radiologic evidence of metastatic disease.
- •Initiated neoadjuvant therapy for current breast cancer diagnosis.
- •Synchronous diagnosis of another invasive cancer, other than this breast cancer, except for non-melanoma skin cancers.
- •Completed all therapy (including endocrine therapy) <5 years ago for any previous invasive solid organ malignancy (with exception of non-melanoma skin cancers) including prior breast cancer. Individuals with a prior history of noninvasive (in situ) carcinomas may participate if they have received definitive treatment.
- •Completed all therapy for any previous hematologic malignancy < 5 years ago.
- •Multicentric or contralateral invasive breast cancers.
- •Known pregnancy at time of enrollment.
- •Prior solid organ transplant.
- •Prior allogeneic hematopoietic stem cell transplant.
结局指标
主要结局
Distant Recurrence Free Interval (dRFI)
时间窗: 6 years
Core biopsy tissue evaluability rate
时间窗: 3 years
次要结局
- Sensitivity/Specificity(6 years)
- Invasive breast cancer-free survival (IBCFS)(6 years)
- Prevalence of test positivity(6 years)
- Recurrence-free interval (RFI)(6 years)
- Event-free survival (EFS)(6 years)
- Overall survival (OS)(6 years)
- Lead Time(6 years)
- Prevalence of tumor mutations and germline variants(6 years)
- Pathologic complete response (pCR) status(6 years)
研究者
研究点 (53)
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