Correlation Between Tumor-infiltrating Lymphocytes and Response to Systemic Therapy in Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 171
- 试验地点
- 1
- 主要终点
- Pathological Complete Response (pCR)
研究概览
简要总结
This study aims to investigate the correlation between immune-related factors in the tumor stroma and pathological complete response (pCR) in patients with early breast cancer treated with neoadjuvant chemotherapy. In addition, the study evaluates the association between immune-related tumor stroma factors and the presence of circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA) in peripheral blood. The study includes serial blood sampling before and after treatment and during follow-up to assess the prognostic value of these biomarkers for disease progression and recurrence.
详细描述
Neoadjuvant chemotherapy is widely used in patients with early breast cancer to reduce tumor size and improve surgical outcomes. Achieving a pathological complete response (pCR) is associated with improved prognosis; however, reliable predictive biomarkers are still limited. Recent evidence suggests that immune cells in the tumor microenvironment may influence treatment response.
This study evaluates immune-related tumor stroma factors (including tumor-infiltrating lymphocytes and immune marker profiles) in tumor tissue obtained prior to treatment. In parallel, circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA) are assessed from peripheral blood samples collected before neoadjuvant chemotherapy, after completion of treatment, and during follow-up.
The primary objective is to determine whether immune-related tumor stroma factors correlate with pCR after neoadjuvant chemotherapy. Secondary objectives include evaluating the association of immune-related factors with the presence of CTCs and ctDNA and assessing their prognostic value for disease progression and recurrence.
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
- •Female patients aged 18 years or older.
- •Histologically confirmed early breast cancer.
- •Candidates for standard neoadjuvant chemotherapy.
- •Ability to provide informed consent.
排除标准
- •Luminal A subtype of breast cancer.
- •Prior systemic therapy for breast cancer.
- •Serious comorbid conditions that would preclude study participation.
研究组 & 干预措施
Early Breast Cancer Patients Receiving Standard-of-Care Neoadjuvant Chemotherapy
Patients with early breast cancer receiving standard-of-care neoadjuvant chemotherapy according to institutional and international guidelines. Treatment is determined by the treating physician and is not assigned by the study protocol.
干预措施: Standard-of-Care Neoadjuvant Chemotherapy (Other)
结局指标
主要结局
Pathological Complete Response (pCR)
时间窗: At surgery following completion of neoadjuvant chemotherapy
Pathological complete response is defined as the absence of invasive carcinoma in the breast and axillary lymph nodes after neoadjuvant chemotherapy (ypT0/Tis ypN0).
次要结局
未报告次要终点