Preoperative Radiotherapy Versus Postoperative Radiotherapy After Neoadjuvant Chemotherapy ("NeoRad") in High-risk Breast Cancer: a Prospektiv, Randomized, International Multicenter Phase III Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,826
- 试验地点
- 32
- 主要终点
- disease free survival (DFS):
研究概览
简要总结
The NEORAD trial tests whether preoperative radiotherapy results in an improved DFS and less radiation induced late effect compared to postoperative radiotherapy in higher risk breast cancer after NACT.
详细描述
The standard of care for high-risk breast cancer consists of neoadjuvant chemotherapy and surgery followed by postoperative whole breast/chest wall irradiation+/- an additional boost (= irradiation restricted to the tumour bed in the case of breast-conserving therapy). In case of lymph node involvement in most patients require additional radiation of the regional lymph nodes. Adjuvant radiotherapy significantly reduces ipsilateral breast cancer recurrences, breast cancer specific mortality, and overall mortality. The optimal time of radiotherapy in patients, who are candidates for neoadjuvant chemotherapy (NACT) has never been addressed in a randomised controlled trial.
The Study Chairman of the NEORAD trial is Prof. Dr. med. Christiane Matuschek. The deputies of the Study Chairman are Prof. Dr. med. Wilfried Budach and Prof. Dr. med. Tanja Fehm.
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
- •Histologically proven invasive, unilateral breast cancer
- •Indication for radiotherapy
- •Indication for neoadjuvant chemotherapy (+/- antibody treatment or other targeted therapies) in accordance with national and international guidelines
- •Informed consent for the trial signed by the patient
- •Hormone receptor and HER2 status: no restrictions
- •All grades G1-G3
- •Age ≥ 18 years at the time of informed consent
- •Performance status ≤ 2
- •No pre-existing conditions that prohibit therapy
排除标准
- •Neoadjuvant treatment solely with endocrine therapy
- •Bilateral breast cancer
- •Pregnancy or lactation
- •Prior radiotherapy of the thorax
- •Connective tissue disease, including rheumatoid arthritis and thromboangiitis obliterans
- •Pre-existing symptomatic chronic lung disease (fibrosis, pneumoconiosis, adult-onset allergies, such as farmer's lung, severe lung emphysema, COPD °III)
- •Cardiac comorbidities: symptomatic coronary heart disease, prior heart attack, heart failure NYHA ≥II or AHA ≥C, pacemaker, and/or implanted defibrillator
- •Malignoma except basalioma or in-situ-carcinomas in complete response
- •Distant metastasis
- •Plexopathies of the arm of the treated side
- •Stiffness of the shoulder of the arm of the side of the breast cancer of any origin (e.g. following a road accident)
- •Lymph edema ≥°II of the arm at the side of the breast cancer
- •Other medical conditions that prohibit the neoadjuvant radiotherapy (i.e. Expected non-compliance, etc.)
- •Male patients
- •Patients who have previously been assessed for chemotherapy response
结局指标
主要结局
disease free survival (DFS):
时间窗: 6 to 10 years
Time interval in which the patient does not show any signs or symptoms of the treated cancer (local or regional recurrence, distant metastases, or death of any cause) beginning after randomisation to a study arm. This is a way to measure how well the new treatment is working.
次要结局
- disease specific survival (DSS)(6 to 10 years)
- Measurement of the quality of life (QOL): functional scale(6 to 10 years)
- disease metastases free survival (DMFS)(6 to 10 years)
- Assessment of arm lymphedema rates by the physicians using common toxicity criteria for adverse events CTCAE, version 5.0(6 to 10 years)
- overall survival (OS)(6 to 10 years)
- Assesment of cosmetic results by the physicians and the patient using a 5 point Scoring System*(6 to 10 years)
- Assesment of cosmetic results by the physicians using breast retraction assessment-Score (BRA Score)*(6 to 10 years)
- local recurrence rate [in affected breast] (LR)(6 to 10 years)
- Assessment of plexopathia higher than Grade 1 of brachial plexus on irradiated side by the physicians using common toxicity criteria for adverse events CTCAE, version 5.0(6 to 10 years)
- locoregional recurrence rate (LRR)(6 to 10 years)
- Measurement of the quality of life (QOL): symptom-related scale(6 to 10 years)
- Assessment of treatment-related toxicity measured by the physicians using standardized common toxicity criteria for adverse events CTCAE, version 5.0.(6 to 10 years)