NCT07832279招募中不适用
1-Week Versus 3-Week Partial Breast Irradiation Using Intensity-Modulated Radiation Therapy (IMRT) Following Breast-Conserving Surgery in Clinically Low-Risk Breast Cancer: a Phase III, Randomized Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 818
- 试验地点
- 1
- 主要终点
- Adverse cosmesis
研究概览
简要总结
This non-inferiority, phase 3 clinical trial evaluates the cosmetic non-inferiority of a one-week regimen (26 Gy/5 Fx) versus a three-week regimen (40 Gy/15 Fx) using intensity-modulated radiation therapy (IMRT) for partial breast irradiation (PBI) in low-risk breast cancer patients post-breast-conserving surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 with an estimated life expectancy greater than 5 years. Meets criteria for either primary invasive breast cancer or pure ductal carcinoma in situ (DCIS).
- •For invasive breast cancer: Age 40-75 years; Underwent breast-conserving surgery with sentinel lymph node biopsy or axillary lymph node dissection; pT ≤ 3 cm (unicentric/unifocal or total multifocal size ≤ 3 cm); favorable histology (invasive ductal, mucinous, tubular, or solid papillary carcinoma, DCIS component permitted); ER+ and/or PR+; pN0(i- or i+); M0; surgical margins ≥ 2 mm.
- •For pure DCIS: Age 18-75 years; Underwent breast-conserving surgery with or without sentinel lymph node biopsy; low-to-intermediate nuclear grade; tumor size ≤ 2.5 cm; surgical margins ≥ 3 mm.
- •Presence of surgical clips or distinct postoperative seroma/tissue changes in the tumor bed allowing precise target delineation.
- •ECOG performance status 0 or
- •Eligible for systemic therapy, without prior neoadjuvant systemic therapy.
- •Able to tolerate radiotherapy procedures and position immobilization.
- •No contraindications to radiotherapy.
- •Written informed consent provided.
排除标准
- •Unfavorable histological subtypes (e.g., invasive lobular carcinoma, invasive micropapillary carcinoma).
- •Positive axillary, internal mammary, or supraclavicular lymph nodes.
- •Presence of distant metastasis.
- •Paget's disease of the nipple.
- •History of prior ipsilateral or contralateral invasive breast cancer or DCIS.
- •Bilateral breast cancer.
- •Known germline BRCA1 or BRCA2 mutation.
- •Prior radiotherapy to the ipsilateral breast, chest wall, or regional lymph nodes.
- •Active or prior second malignancy (except adequately treated non-melanoma skin cancer).
- •Severe non-malignant comorbidities (e.g., cardiovascular disease, pulmonary disease, systemic lupus erythematosus, or scleroderma) precluding definitive radiotherapy.
- •Pregnant or lactating patients.
- •Inability or unwillingness to comply with scheduled follow-up visits.
研究组 & 干预措施
arm 1
Experimental
26Gy/5F
干预措施: 1-week PBI (Radiation)
arm 2
Active Comparator
40.05Gy/15F
干预措施: 3-week PBI (Radiation)
结局指标
主要结局
Adverse cosmesis
时间窗: 3 years
Adverse cosmetic outcome (defined as 'Fair' or 'Poor') was evaluated by an independent panel using standard photographic assessment based on the EORTC Cosmetic Rating System.
次要结局
- Locoregional recurrence(5 years)
- Overall survival(5 years)
研究者
研究点 (1)
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