A Prospective Phase II Clinical Study of Response-Based Local Therapy After Systemic Therapy in Regionally Advanced Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 157
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
The goal of this interventional clinical trial is to evaluate if an individualized treatment strategy (involving radiation boost, surgery, and systemic consolidation) can improve progression-free survival in patients with breast cancer presenting with positive ipsilateral supraclavicular (ISLN) and/or internal mammary lymph nodes (IMLN).
The main questions it aims to answer are:
Is individualized hypofractionated radiotherapy with a local boost safe and effective when adjusted by the response to neoadjuvant treatment?
Does local surgery provide benefit for patients who have high residual tumor burden in these lymph nodes after neoadjuvant treatment?
How effective is intensified systemic therapy when tailored to the patient's molecular subtype?
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 18 to 75 years.
- •ECOG performance status ≤
- •Histologically confirmed invasive breast cancer.
- •Newly diagnosed breast cancer with pathologically confirmed positive ipsilateral supraclavicular lymph nodes (ISLN) and/or internal mammary lymph nodes (IMLN); for patients in whom IMLN biopsy is not feasible, clinically positive IMLN based on investigator assessment and imaging findings is acceptable.
- •Planned to receive neoadjuvant systemic therapy followed by breast-conserving surgery or mastectomy and axillary lymph node dissection, with or without supraclavicular and/or internal mammary lymph node dissection.
- •Adequate baseline organ function, defined as: absolute neutrophil count ≥ 1.5 × 10⁹/L; platelet count ≥ 100 × 10⁹/L; hemoglobin ≥ 9 g/dL (90 g/L); serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance ≥ 60 mL/min; total bilirubin ≤ 1.5 × ULN; AST and/or ALT ≤ 2.5 × ULN; INR ≤ 1.5 and PT/APTT ≤ 1.5 × ULN.
- •Able and willing to comply with study procedures and scheduled follow-up.
- •Written informed consent obtained prior to any study-related procedures.
排除标准
- •Evidence of distant metastatic disease.
- •Presence of severe or uncontrolled concomitant diseases, including severe cardiac dysfunction; myocardial infarction, uncontrolled arrhythmia, or unstable angina within 3 months prior to enrollment; clinically significant pericardial disease; or severe pulmonary disease.
- •Prior radiotherapy to the chest wall or supraclavicular region.
- •Pregnancy, lactation, or any condition considered by the investigator to contraindicate radiotherapy.
- •History of or concurrent second primary malignancy, except for non-melanoma skin cancer, papillary or follicular thyroid carcinoma, carcinoma in situ of the cervix, contralateral non-invasive breast cancer, or other malignancies treated with curative intent with no evidence of disease for more than 3 years.
研究组 & 干预措施
Response-Adapted comprehensive treatment strategy
干预措施: Response-adapted comprehensive treatment strategy (Radiation)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: Up to 5 years
次要结局
- Overall Survival (OS)(Up to 5 years)
- Cumulative Incidence of Locoregional Recurrence(Up to 5 years)
- Cumulative Incidence of Distant Metastasis(Up to 5 years)
- Incidence of Treatment-Related Toxicities(Up to 5 years)
研究者
Shulian Wang,MD
Chief Physician
Cancer Institute and Hospital, Chinese Academy of Medical Sciences