A Dose Escalation Study of Proton and Carbon Ion Irradiation for HER2 Positive and Triple Negative Breast Cancer After Breast Conserving Surgery
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Acute toxicity
研究概览
简要总结
Adjuvant radiotherapy is the standard treatment for early breast cancer after breast conserving surgery. Molecular subtypes was significantly associated with the risk of local recurrence of breast cancer. Nguyen et al found that the overall 5-year cumulative incidence of local recurrence was 0.8% for luminal A, 1.5% for luminal B, 8.4% for HER2 positive, and 7.1% for triple negative breast cancer after lumpectomy and radiotherapy. Her2 positive and triple negative breast cancers may be inherently radioresistant.
Therefore, for HER2 positive and triple negative breast cancer with high local recurrence and radiation resistance, proton combined with carbon ion is proposed after breast conserving surgery.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed HER2 positive or Triple Negative invasive breast carcinoma.(HER2 positive: immunohistochemistry [IHC] 3+ and or fluorescence in situ hybridization [FISH] amplified; Triple Negative: estrogen receptor [ER] and progesterone receptor [PR] < 1%, HER2 negative [IHC 1+ or 2+ FISH non-amplified])
- •Age ≥ 18 years and ≤ 80 years.
- •The primary tumor must be excised via breast conserving surgery.
- •Stage p T1-2 N0 M0
- •ECOG performance status ≤2.
排除标准
- •Invasive breast cancer not confirmed by pathology.
- •Distant metastasis
- •Prior thoracic radiation.
- •Pregnancy or lactating.
结局指标
主要结局
Acute toxicity
时间窗: 3 months after the completion of CIRT
Treatment related acute toxicity assessed by CTCAE v4.03
次要结局
- Local regional recurrence(within 5 years after radiotherapy.)
- Cosmetic outcome as measured by Breast Cancer Treatment Outcomes Scale(within 5 years after radiotherapy.)
- Cosmetic outcome as measured by BCCT.core software(within 5 years after radiotherapy.)
研究者
Qing Zhang,MD
Professor
Shanghai Proton and Heavy Ion Center