IIT2023-09-Chung-UpfrontTAD: Upfront TAD/SNB in Patients With Clinical T1-2N0 ER+ Her2- Breast Cancer With Ultrasound Detected Nodal Metastases
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 6
- 主要终点
- Regional recurrence rate
研究概览
简要总结
The purpose of the study is to determine the recurrence rates and survival of patients with clinical T1-2N0 ER+/Her2- invasive breast cancer who have biopsy proven image detected nodal disease treated with upfront lumpectomy or mastectomy with TAD followed by adjuvant therapy. This is a prospective, single arm phase II clinical trial. Patients will be screened and enrolled per eligibility criteria. Patient, tumor, and treatment data will be documented.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women age ≥ 45
- •Clinical T1-2N0 ER+ invasive breast cancer
- •US detected biopsy proven axillary nodal disease
- •Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
排除标准
- •Palpable nodes on physical exam
- •Her2+ or ER- invasive breast cancer
- •Extranodal extension > 3 mm on nodal biopsy
- •More than 2 suspicious nodes on preoperative imaging
研究组 & 干预措施
Single Arm
干预措施: Adjuvant Radiation Therapy (Radiation)
Single Arm
干预措施: Breast Surgery (BCS or mastectomy) with TAD/SNB (Procedure)
结局指标
主要结局
Regional recurrence rate
时间窗: 5 Years
Regional recurrence rate is defined as the percentage of patients who experience a regional recurrence during follow-up period.
次要结局
- Local recurrence rate(5 Years)
- Disease-free survival (DFS)(5 Years)
- Breast cancer specific survival (BCSS) rate(5 Years)
- Overall survival (OS)(5 Years)
研究者
Alice Chung
Sponsor-Investigator
Cedars-Sinai Medical Center