Neoadjuvant Chemotherapy Followed by Radiotherapy Alone in Patients With Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Ipsilateral breast tumor recurrence (IBTR)
研究概览
简要总结
After neoadjuvant chemotherapy, patients normally receive either conservative breast surgery or mastectomy followed by radiation therapy. Some patients achieve a complete response after neoadjuvant chemotherapy. Considering that radiation therapy is an effective treatment for subclinical microscopic disease, the question arises whether breast surgery before radiation therapy can be avoided in the subgroup of patients with complete response after neoadjuvant chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 40 years or older
- •Pathologically confirmed unicentric invasive breast cancer
- •Clinical stage T1-3 / N0 or N2 / M0
- •Clinical conditions to receive neoadjuvant chemotherapy
排除标准
- •Prior diagnosis of cancer (exception: in situ cervical tumor and non-melanoma skin)
- •Patient is known to be pregnant
- •Prior history of radiation therapy in the thoracic region
- •Impossibility to perform magnetic resonance imaging
结局指标
主要结局
Ipsilateral breast tumor recurrence (IBTR)
时间窗: 5 years
IBTR is defined from the date from complete response of neoadjuvant chemotherapy to the date of any ipsilateral locoregional recurrence or deth.
次要结局
未报告次要终点
研究者
Gustavo Nader Marta
Radiation Oncologist and Principal Investigator
Instituto do Cancer do Estado de São Paulo