Evaluation of circulating tumor DNA (ctDNA) and Circulating Tumor Cells (CTC) for detecting Minimal Residual Disease in Early-Stage Triple-Negative Breast Cancer Post-Neoadjuvant Chemotherapy.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- i. Pathological Complete Response (pCR)
研究概览
简要总结
This study is single centered, Observational, Longitudnal, Cohort study The primary purpose of this observational study is to evaluate the effectiveness of neoadjuvant chemotherapy (NACT) in patients with early-stage triple-negative breast cancer (TNBC) by assessing primary outcomes such as pathological complete response (pCR), overall survival (OS), progression-free survival (PFS), and disease-free survival (DFS). Additionally, the study aims to investigate the correlation between circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA) levels post-NACT with disease progression. These biomarkers will be evaluated for their potential to serve as reliable indicators of NACT efficacy and predictors of short-term clinical outcomes in early-stage TNBC patients.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- Female
入选标准
- •Diagnosis: Confirmed early-stage triple-negative breast cancer (TNBC).
- •Treatment: Eligible for neoadjuvant chemotherapy (NACT) for TNBC.
- •Age: Females 18 and above Consent: Able and willing to provide informed consent.
- •Organ Function: Adequate liver, renal, and blood counts.
- •Follow-up Compliance: Willingness for regular follow-up and blood sampling.
- •Baseline Sample: Available baseline blood sample pre-NACT.
排除标准
- •Metastatic Disease: Presence of metastatic breast cancer.
- •Previous Malignancies: Other malignancies within a specified recent period.
- •Concurrent Trials: Participation in other clinical trials with investigational drugs.
- •Major Health Conditions: Uncontrolled diabetes, severe cardiovascular diseases, or infections.
- •Pregnancy/Breastfeeding: Currently pregnant or breastfeeding.
结局指标
主要结局
i. Pathological Complete Response (pCR)
时间窗: 3 years
ii. Overall Survival (OS)
时间窗: 3 years
iii. Progression-Free Survival (PFS):
时间窗: 3 years
iv. Disease-Free Survival (DFS):
时间窗: 3 years
次要结局
- i. Recurrence Rate(ii. CTC and ctDNA Levels Correlation with Survival Outcomes)
研究者
Dr Bhuvan Chugh
Max Super Speciality Hospital Saket (East Block) (A unit of Devki Devi Foundation)