Accelerated Partial Breast Irradiation in One Fraction for Patients With Early-stage Disease and Favorable Histological Subtypes (Breast-1F).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 311
- 试验地点
- 2
- 主要终点
- Ipsilateral Breast Tumor Recurrence (IBTR)
研究概览
简要总结
This is a prospective, randomized, monocentric, non-inferiority interventional clinical study comparing an Accelerated Partial Breast Irradiation (APBI) for the surgical bed of early-stage breast cancer patients with favorable histological subtypes, using stereotactic radiotherapy in a single dose of 15.5 Gy with Simultaneous Integrated Boost (SIB) to 21 Gy (study treatment, delivered in a single fraction) versus multifractionated radiotherapy of 30 Gy in 5 fractions (standard treatment, delivered in 5 fractions).
详细描述
The project refers to a study on patients with early-stage breast cancer with pathological Tumor stage (pT) from in situ (pTis) to pT2 up to 3 cm in diameter, and pathological/clinical nodal stage p/cN0, and favorable histology (Luminal A and Luminal B human epidermal growth factor receptor 2 (HER2)-negative subtypes), comparing an APBI treatment delivered with stereotactic radiotherapy to the Planning Target Volume (PTV) of the tumor bed of the breast with a total dose (TD) of 15.5 Gy in one fraction, with simultaneous integrated boost (SIB) to a TD of 21 Gy to the Gross Tumor Volume (GTV) represented by tumor bed, versus 30 Gy in 5 consecutive fractions to the PTV of the tumor bed, according to the standard APBI protocol of the department (Florence protocol).
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histological diagnosis of breast cancer
- •Patients aged ≥40 years
- •Signed informed consent
- •Stage pTis-T2, up to 3 cm in the greatest diameter
- •Luminal A and Luminal B HER2-negative histological subtypes
- •Negative surgical margins (≥ 0.2 cm)
- •Negative lymph nodes at sentinel lymph node biopsy, or alternatively with imaging tests (Positron Emission Tomography (PET)/Computed Tomography (CT) and/or axillary ultrasound, and/or breast Magnetic Resonance Imaging (MRI) with and without contrast), or, in rare cases, where still performed, with axillary dissection
- •Clinical M0 (PET/CT and/or bone scintigraphy and/or abdomen-pelvis CT with and without contrast in suspected patients), within the previous 3 months.
- •Performance Status (PS) Eastern Cooperative Oncology Group (ECOG) ≤2
- •No prior thoracic radiotherapy
- •Fertile women using contraception methods initiated during oncological treatment.
排除标准
- •Patients aged < 40 years
- •Tumors > 3 cm
- •Multicentric tumors
- •Positive or close surgical margins (<0.2 cm)
- •Lobular carcinoma
- •Negative hormone receptors
- •HER2-positive
- •BReast CAncer (BRCA) genes BRCA1 and/or BRCA2 positive (only if known)
- •Severe systemic diseases
- •Psychiatric or other disorders that may prevent the patient from signing informed consent
- •Previous invasive cancer, except for skin cancer (excluding melanoma) unless the patient has been disease-free for at least 3 years (e.g., carcinoma in situ of the oral cavity or bladder)
- •Collagen or autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, scleroderma, Sjogren's syndrome)
- •Lymph node disease (N1)
- •Evidence of distant metastasis (M1)
- •Contraindication to systemic treatment
- •Pregnant women
- •Non-compliance with the dose limits established in the treatment plan
研究组 & 干预措施
Arm 1- Single-fraction APBI
Patients in the study (randomized to arm 1) will be treated with a total dose (TD) of 15.5 Gy to the Planning Tumor Volume (PTV) with simultaneous integrated boost (SIB) to a TD of 21 Gy to the tumor bed. For each patient, a stereotactic radiotherapy treatment plan will be created to ensure adequate coverage of the treatment volumes and the tolerability of the Organs At Risk (OAR). Specific, already validated dose-volume constraints will be applied for the evaluation of OARs. The dose-volume histogram (DVH) for the Gross Tumor Volume (GTV), Clinical Target Volume (CTV), PTV, and OAR will be calculated in order to achieve the best optimization in terms of tolerability and efficacy.
干预措施: Adjuvant single-fraction accelerated partial breast irradiation (Radiation)
Arm 2- Five-fractions APBI
Patients randomized to arm 2 will be treated according to the standard APBI protocol of our department (Florence protocol), delivering a TD of 30 Gy in 5 fractions to the tumor bed.
干预措施: Adjuvant single-fraction accelerated partial breast irradiation (Radiation)
结局指标
主要结局
Ipsilateral Breast Tumor Recurrence (IBTR)
时间窗: 5 years
To demonstrate the non-inferiority of local control (ipsilateral breast tumor recurrence - IBTR) of the study treatment (delivered in a single-fraction APBI) compared to the department's standard APBI treatment (delivered in 5 fractions).
次要结局
- Local Control(5 years)
- Local Relapse-Free Survival (LRFS)(From the date of radiotherapy end until the date of local relapse, assessed up to 5 years)
- Regional Relapse-Free Survival (RRFS)(From the date of radiotherapy end until the date of regional relapse, assessed up to 5 years)
- Distant Metastasis-Free Survival (DMFS)(From the date of radiotherapy end until the date of distant metasis diagnosis, assessed up to 5 years)
- Breast Cancer Specific Survival (BCSS)(From the date of radiotherapy end until the date of death from breast cancer, assessed up to 5 years)
- Overall Survival (OS)(From the date of radiotherapy end until the date of death from any cause, assessed up to 5 years)
- Cosmesis(5 years)
- Acute toxicity interim analysis(3 months)
- Late toxicity interim analysis(42 months)
- Local relapse interim analysis(42 months)
- Acute toxicity(3 months)
- Late toxicity(5 years)
- Disease-Free Survival (DFS)(From the date of radiotherapy end until the date of first, any ( local, regional, distant) relapse, assessed up to 5 years)
- Acute toxicity(1 month)
研究者
Andrei Fodor, MD
Principal Investigator
IRCCS San Raffaele