A Multicenter, Randomized, Controlled Phase III Clinical Trial Comparing Ultra-Hypofractionated Versus Moderate Hypofractionated Radiotherapy for Regional Lymph Nodes in Post-operative Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,950
- 试验地点
- 1
- 主要终点
- Invasive Breast Cancer Recurrence-Free Survival (IBC-RFS)
研究概览
简要总结
For patients with breast cancer, regional nodal irradiation (RNI) can significantly reduce the risks of recurrence and mortality. Moderate hypofractionated regimens (40 to 42.5 Gy in 15 to 16 fractions over 3 weeks) is the established standard of care for RNI. Nevertheless, for the majority of patients, a three - week treatment duration is still regarded as lengthy. Although the ultra-hypofractionated regimen (26 Gy in 5 fractions over 1 week) has been proven non-inferior to the moderate hypofractionated regimen for whole breast irradiation, unambiguous evidence supporting its use in comprehensive RNI remains lacking, especially in high risk patients requiring internal mammary node irradiation (IMNI). This prospective, non-inferiority trial is designed to address this evidence gap by evaluating whether a one-week, ultra-hypofractionated regimen (26 Gy in 5 fractions) is non-inferior to the three-week regimen (40 Gy in 15 fractions) for comprehensive RNI, including IMNI.
详细描述
The study intervention is RNI delivered using modern techniques, including Intensity-Modulated Radiation Therapy (IMRT), Volumetric Modulated Arc Therapy (VMAT) or Intensity-Modulated Proton Therapy (IMPT). Technical parameters for treatment delivery, such as target delineation and OARs dose constraints, will be standardized across both arms. The investigational component is the randomized comparison of the ultra-hypofractionated regimen (26 Gy in 5 fractions over one week) and the moderate hypofractionated regimen (40 Gy in 15 fractions over three weeks).
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Provide a signed and dated informed consent form (ICF) before the initiation of any trial-specific procedures.
- •Age ≥ 18 years.
- •Histologically confirmed invasive breast cancer.
- •Have received breast-conserving surgery or mastectomy with axillary staging, including sentinel lymph node biopsy, targeted axillary dissection and/or axillary lymph node dissection.
- •Tumor stage is classified as T1, T2, or T3, as defined by the AJCC Cancer Staging Manual, 8th Edition.
- •Meeting at least one of the following conditions:
- •Pathological nodal status of pN2 or pN3a;
- •Pathological nodal status of pN1 with one or more of the following high-risk factors:
- •(I), Age < 40 years. (II), Tumor location in the central or inner quadrant. (III), Estrogen Receptor (ER) negative. (IV), Presence of lymphovascular invasion (LVI). (V), Histological grade III. (VI), Patients presenting with clinical stage cN2-3a before neoadjuvant treatment.
- •Pathologically negative surgical margins, defined as "no ink on tumor."
- •Karnofsky Performance Status (KPS) score ≥
- •Documented biomarker status for Estrogen Receptor (ER), Progesterone Receptor (PR), HER2, and Ki-
- •Sufficient wound healing from surgery, with no signs of active infection at the intended radiation site.
排除标准
- •Nodal stage is classified as N3b or N3c, as defined by the AJCC Cancer Staging Manual, 8th Edition.
- •Has undergone or is planning immediate breast reconstruction with a permanent implant or tissue expander.
- •Evidence of distant metastatic disease.
- •Diagnosis of synchronous bilateral invasive breast cancer or a history of prior invasive cancer in either breast.
- •History of prior radiation therapy to the chest, axillary, or supraclavicular regions.
- •Known active collagen vascular diseases, particularly systemic lupus erythematosus or scleroderma, which are contraindications to radiotherapy.
- •Presence of any severe, uncontrolled co-morbidity or medical condition that, in the investigator's judgment, would render the participant unsuitable for the study, compromise protocol compliance, or confound the interpretation of study results.
- •History of any other malignancy within the 5 years before enrollment, with the exception of adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix.
- •Participants who are pregnant or lactating at the time of study enrollment. (Note: In accordance with the standards of each participating institution, women of childbearing age are required to undergo pregnancy testing within 2 weeks prior to randomization.)
研究组 & 干预措施
Moderate hypofractionated regimen
Participants will receive moderate hypofractionated radiotherapy to regional lymph nodes and chest wall/whole breast. For patients after breast-conserving surgery, a simultaneous integrated boost to the tumor bed will be administered. Systemic therapy (chemotherapy, endocrine therapy, or targeted therapy) will be given according to standard clinical practice.
干预措施: Moderate Hypofractionated Regional Nodal Irradiation (Radiation)
Ultra-hypofractionated regimen
Participants will receive ultra-hypofractionated radiotherapy to regional lymph nodes and chest wall/whole breast. For patients after breast-conserving surgery, a sequential boost to the tumor bed will be administered. Systemic therapy (chemotherapy, endocrine therapy, or targeted therapy) will be given according to standard clinical practice.
干预措施: Ultra-hypofractionated Regional Nodal Irradiation (Radiation)
结局指标
主要结局
Invasive Breast Cancer Recurrence-Free Survival (IBC-RFS)
时间窗: 5 years
IBC-RFS, defined as time from randomization until any first invasive ipsilateral breast, chest wall, regional, or distant recurrence, or death from breast cancer. Data for patients who are alive and free of an event at the time of final analysis or are lost to follow-up will be censored at the date of last contact.
次要结局
- Acute Radiation-Induced Toxicity(From start of radiotherapy through 90 days after completion of radiotherapy)
- Late Radiation-Induced Toxicity(From 90 days after completion of radiotherapy to 10 years)
- Overall Survival (OS)(10 years)
- Locoregional Recurrence-Free Survival (LRRFS)(10 years)
- Distant Metastasis-Free Survival (DMFS)(10 years)
- Disease-Free Survival (DFS)(10 years)