Phase III Multicentric Trial Comparing Accelerated Partial Breast Irradiation (APBI) Versus Standard or Hypofractionated Whole Breast Irradiation in Low Risk of Local Recurrence of Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- UNICANCER
- 入组人数
- 1,006
- 试验地点
- 40
- 主要终点
- rate of local recurrence
研究概览
简要总结
The standard treatment for localized breast cancer is based on conservative surgery (when possible) followed by radiation therapy (RT) delivered to the whole breast. The recommended total RT dose is 45 to 50 Gy delivered in 4.5 to 5 weeks followed by a 10 to 16 Gy boost to the tumor bed for 1 to 1.5 weeks. The rationale for the development of APBI was based on the difficulty for many patients to reach RT centers to receive standard whole breast irradiation (WBI) after conservative surgery. APBI offers decreased overall treatment time and several theoretical advantages over WBI, including a decrease in dose delivered to uninvolved portions of the breast and adjacent organs. If equivalence between the two treatments can be shown, then APBI will be considered as a historic evolution in breast cancer management.
In this phase III trial, designed in postmenopausal women >50 years of age, the objective is to compare the effectiveness and safety of APBI compared with whole breast irradiation. This study is also designed to ensure high quality criteria for surgery, pathology and RT techniques in the 3 arms and will allow to provide data on economics and costs.
详细描述
Following breast conservative surgery, patients will be stratified according to the following prognostic factors using a minimisation technique: age (<70 vs ≥70), HER2 status (HER2+ vs HER2-), hormonal receptor status (RH+ vs RH-) and lymph node invasion (pN0 vs pN0i+).
Patients will be allocated to receive either standard treatment, hypofractionated treatment or APBI.
Radiation therapy should be started between 4 and 12 weeks after the last surgery.
Patients treated with standard whole breast irradiation will receive a total dose of 50 Gy in 25 fractions, 2 Gy per day, 5 days a week. The boost of 16 Gy will be delivered in 8 fractions for all patients after completion of the 50 Gy, without interruption. All patients will receive one fraction per day, 5 fractions a week.
Patients treated with hypofractionated irradiation will receive a total dose of either 40 Gy (in 15 fractions, 2.66 Gy per day) or 42.5 Gy (in 16 fractions, 2.65 Gy per day) 5 days a week.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged ≥50 years
- •Menopausal status confirmed
- •Pathology confirmation of invasive carcinoma (all types)
- •Complete tumor removal and conservative surgery
- •Pathologic tumor size of invasive carcinoma ≤2 cm (including the in situ component) pT1
- •All histopathologic grades
- •Clear lateral margins for the invasive and in situ disease (>2 mm)
- •pN0 or pN(i+)
- •No metastasis
- •Radiotherapy should be started more than 4 weeks and less than 12 weeks after last surgery
- •Surgical clips (4 to 5 clips in the tumor bed)
- •No prior breast or mediastinal radiotherapy
- •Eastern Cooperative Oncology Group (ECOG) 0-1
- •Information to the patient and signed informed consent
排除标准
- •Multifocal invasive ductal carcinoma defined as the presence of at least two distinct tumors that are separated by normal tissue or when the distance between the two lesions does not permit conservative surgery
- •Bilateral breast cancer
- •No or less than 4 surgical clips in the tumor bed
- •Nodal involvement : pN1 (including micrometastasis, mi+), pN2, pN3
- •Metastatic disease
- •internal mammary node involvement or supraclavicular lymph node involvement
- •Indication of chemotherapy or trastuzumab
- •Involved or close lateral margins for the invasive and /or in situ components (<2 mm) AND impossibility to re-operate or impossible to perform another conservative surgery
- •Patients with known BRCA1 or BRCA2 mutations
- •Previous mammoplasty
- •Previous homolateral breast and/or mediastinal irradiation
- •Previous invasive cancer (except basocellular epithelioma or in situ carcinoma of the cervix)
- •No geographical, social or psychologic reasons that would prevent study follow
结局指标
主要结局
rate of local recurrence
时间窗: 5 years
To estimate and compare the rate of local recurrence between the experimental and control arms.
次要结局
- Ipsilateral breast recurrence-free survival(10 years)
- Nodal regional recurrence-free survival(10 years)
- Distant recurrence-free survival(10 years)
- Overall survival(10 years)
- Cosmetic: comparison of the cosmetic result (according to both the physician and the patient)(10 years)
- Disease-specific survival(10 years)
- Toxicities: Measurement of the rate and type of toxicity (acute and late toxic effects)(10 years)
- Medico-economic study(3 years)
- Quality of Life and Satisfaction(10 years)