NCT06867484招募中不适用
Breast Re-irradiation After Second Ipsilateral Lumpectomy (BRASIL Trial)
Youssef Zeidan2 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2025年10月27日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 114
- 试验地点
- 2
- 主要终点
- Rate of grade 3 or higher treatment-related adverse events (AEs)
研究概览
简要总结
The purpose of this research study is to test the safety and possible harms of treating breast cancer with reirradiation, after breast surgery. The researchers want to find out what effects (good and bad) reirradiation has on people who have already received radiation before surgery.
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
- •Diagnosed with ER+HER2- breast cancer
- •Provision of signed and dated ICF
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Age ≥ 40 years
- •Oncotype < 26 (postmenopausal) <16 (premenopausal), Low, or Ultra-Low index.
- •Minimum interval of 18 months from last breast radiotherapy session.
- •Prior radiation therapy in the form of brachytherapy, external beam MV photons, protons or intraoperative radiation are allowed with an upper total dose limit of 68 Gy (EQD2) for those patients with prior records available.
- •Ipsilateral recurrence, unifocal < 3 cm with negative margins, N0, Tis and invasive (pathological staging)
- •Eastern Cooperative Oncology Group (ECOG) ≤ 2
- •Planning target volume: whole breast (PTV: WB) ratio < 1/2
- •Life expectancy > 12 months
- •Individuals able to become pregnant: agreement to use highly effective contraception starting at screening through treatment, and for 1 year after the end of PBI. Should a participant become pregnant or suspect that they are pregnant while participating in this study, they should notify the treating physician immediately.
- •A person able to become pregnant is any person assigned female at birth (regardless of gender identity, sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- •Has not undergone a hysterectomy or bilateral oophorectomy; or
- •Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has not had menses at any time during the preceding 12 consecutive months)
排除标准
- •BRCA1/2 mutation or any other receptor subtypes
- •Individuals assigned male at birth with breast cancer
- •Pregnancy or breastfeeding
- •Skin involvement
- •Distant metastasis
- •Patients with initial high-risk triple negative or HER-2 enriched breast cancer will be excluded from the trial. However, if the initial subtype is not known, patients will still be allowed to enroll, and the initial primary tumor information will be recorded as missing on the clinical forms.
- •Other malignancies (except skin)
- •Connective tissue disorder (e.g., scleroderma, lupus)
- •Any other condition that may put a participant at higher risk, at the discretion of the investigator.
研究组 & 干预措施
Partial Breast Irradiation (PBI)
Experimental
干预措施: Intensity modulated radiation therapy (IMRT) (Radiation)
结局指标
主要结局
Rate of grade 3 or higher treatment-related adverse events (AEs)
时间窗: 1 year
Adverse events will be collected using Common Terminology Criteria for Adverse Events version 5 (CTCAE v5) starting from the first radiation treatment. Grade 1 AEs are considered mild, grade 2 AEs are considered moderate, grade 3 AEs are considered severe, grade 4 AEs are considered life-threatening, and grade 5 AEs are considered fatal. The percentage of participants experiencing grade 3 or higher treatment-related AEs will be calculated.
次要结局
- Local recurrence-free survival (LRFS)(5 years)
- Overall survival (OS)(5 years)
- Distant metastasis-free survival (DMFS)(5 years)
- Mastectomy-free survival (MFS)(5 years)
- Change in patient-rated cosmesis(Over 5 years)
研究者
Youssef Zeidan
Radiation Oncologist
Baptist Health South Florida
研究点 (2)
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