Radiation Omission in Patients With HER2 Overexpressing Tumors With Pathologic
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Feasibility of enrolling patients measured by proportion of recruited patients to participate in the trial
研究概览
简要总结
The purpose of this study is to evaluate the feasibility, based on recruitment rate over a 3-year period, of enrolling patients for the omission of post-operative breast radiation following breast conserving surgery and sentinel node biopsy or axillary lymph node dissection in women with HER2+ breast cancer who achieve pathologic complete response.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 40 years
- •Patients must have a tissue diagnosis of HER2+ breast cancer
- •Patients must have documented clinical T1-3, N0, M0 disease prior to receiving neo-adjuvant chemotherapy
- •Patients must have undergone neo-adjuvant chemotherapy and targeted HER2 therapy prior to surgery and plan for completion of adjuvant systemic therapy as directed by their medical oncologist
- •Patients must have completed partial mastectomy/lumpectomy and sentinel node biopsy or axillary node dissection.
- •Patient must have documented pathologic complete response (defined as no residual invasive or in situ disease in the breast or axilla, including free of isolated tumor cells or micrometastasis)
排除标准
- •Breastfeeding
- •Prior history of breast cancer (invasive or ductal carcinoma in-situ) in either breast
- •Prior adjuvant radiation therapy
- •Patients with diagnosis of inflammatory breast cancer
- •Patients with known BRCA mutation or other known breast cancer related deleterious mutations
结局指标
主要结局
Feasibility of enrolling patients measured by proportion of recruited patients to participate in the trial
时间窗: At time of consent. Assessed up to 3 years
Measured by the number of recruited patients over the number of patients approached to participate to the trial. Feasibility will be defined as recruitment rate of greater or equal to 25% among patients who are eligible to participate in the trial.
次要结局
未报告次要终点
研究者
Armando Giuliano
Chief, Surgical Oncology
Cedars-Sinai Medical Center