RADIation After no Axillary Nodal Sampling (RADIANS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Rate of Axillary Recurrence
研究概览
简要总结
This is a single arm, pilot, prospective study to evaluate the safety of partial breast irradiation in women who undergo breast conserving surgery without sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND). Baseline demographic and clinical information will be collected. All patients will complete the Breast Cancer Treatment Outcome Scale (BCTOS-13) questionnaire and the Functional Assessment of Chronic Illness Therapy-Comprehensive Score for financial Toxicity at baseline and at 2 years. All patients are required to have an axillary ultrasound prior to radiation start if this was not obtained pre-operatively.
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
- •Individuals assigned Female at birth, age 40 and older
- •Breast conserving surgery without SLNB or ALND
- •All patients should be capable of giving informed consent,
- •Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
- •Histologically confirmed invasive ductal carcinoma
- •Individuals with pathologic tumor size <3cm
- •Patients in whom partial breast is deemed technically not possible due to breast size will be considered screen failures and excluded from the trial.
- •Clinically and radiologically node-negative (no palpable nodes, negative axillary imaging)
- •Electrocorticography (ECOG) performance status 0-2
排除标准
- •Transgender or non-binary individuals.
- •Mastectomy
- •Metastatic disease
- •History of ipsilateral or contralateral breast cancer.
- •Obstacles to obtaining informed consent or undergoing regular follow-up
结局指标
主要结局
Rate of Axillary Recurrence
时间窗: Up to Year 5-post-radiation
Proportion of patients in whom the return of breast cancer in the lymph nodes of the armpit is observed.
次要结局
- Rate of Local Recurrence(Up to Year 5-post-radiation)
- Rate of Distant Recurrence(Up to Year 5-post-radiation)
- Breast-Cancer Specific Survival(Up to Year 5-post-radiation)
- Overall Survival(Up to Year 5-post-radiation)
- Rate of Endocrine Therapy Initiation(Up to Year 5-post-radiation)
- Rate of Endocrine Therapy Adherence(Up to Year 5-post-radiation)
- Change in Breast Cancer Treatment Outcome Scale (BCTOS-13) Score(Baseline, Year 2 Post-Radiation)
- Functional Assessment of Chronic Illness Therapy - COmprehensive Score for Financial Toxicity (COST-FACIT)(Baseline, Year 2 Post-Radiation)