Radiotherapy in Preoperative Setting With CyberKnife as Treatment in Early Breast Cancer: an Explorative Study
试验速览
- 阶段
- 不适用
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Rate of acute skin toxicity events, measured according to RTOG/EORTC scale
研究概览
简要总结
The aim of this study is to prospectively evaluate, in patients affected by early breast cancer, safety and feasibility of single fraction radiotherapy with Cyberknife R in preoperative setting, and to identify factors predictive for outcome based on biologic and clinical parameters.
详细描述
Monocentric, open-label, single-arm phase II study evaluating safety and efficacy of neoadjuvant radiotherapy in early breast cancer patients. Patients eligible are women aged 50 or more years old, affected by histologically proven invasive breast cancer, with positive hormonal receptors, grading 1 or 2, HER-2 negative, without lymphovascular invasion, and tumour size up to 2 cm (measured on mammography, ultrasound or magnetic resonance), negative clinical nodal status, eligible for BCS.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Women ≥ 50 years old
- •Histological diagnosis of invasive breast cancer
- •ER positive (≥ 10% of tumoral cells present ER) and/or PR positive (≥ 10% of tumoral cells present PR)
- •Grading 1 or 2
- •Her2 negative (IHC 0-1+; in patients with IHC 2+, absence of amplification at FISH
- •No lymphovascular invasion evidence at biopsy
- •Early breast cancer (T1 N0 M0) clinically and radiologically defined (ultrasound study/ magnetic resonance)
- •Patients eligible for BCS.
排除标准
- •Extension of breast disease within 5 mm from the skin surface
- •Tumor size > 2 cm
- •Patients affected by collagenopathies
- •Patients with BRCA1/2 mutations
- •Previous irradiation to homolateral breast
- •Previous irradiation to homolateral thoracic wall
- •DCIS and/or Paget's disease
- •Psychiatric disorders preventing informed consent signature.
结局指标
主要结局
Rate of acute skin toxicity events, measured according to RTOG/EORTC scale
时间窗: 15 days
Acute skin toxicity (from the end of radiotherapy to surgery) according to Radiation Therapy Oncology Group (RTOG)/ European Organization for research and treatment of cancer (EORTC) scale. Measuring acute skin toxicity from a minimum of 0 (no change over baseline) to a maximum of 4 (Ulceration, Hemorrage, necrosis)
次要结局
- Number of patients dying for breast cancer at 36 months(36 months)
- Number of patients free from metastatic progression at 36 months(36 months)
- Number of patients dying for any cause at 36 months(36 months)
- Number of patients with pathologic complete response (pCR) after surgery,according to Chevalier score(30 days)
- Number of patients free from locoregional progression at 36 months(36 months)
- Correlation of differential genetic expression, immunologic and histopathologic features of tumor sample and biomarkers in blood and urine samples with toxicity and rate of response to radiotheraèy(60 days)
- Number of patients with complete resection after surgical excision(30 days)
- Rate of chronic skin toxicity events, measured according to CTCAE(90 days)
- Rate of chronic extra-cutaneous toxicity, measured according to CTCAE(90 days)
研究者
Lorenzo Livi
Full Professor
Azienda Ospedaliero-Universitaria Careggi