Safety of Breast Conserving Treatment in Locally Advanced Breast Cancer Receiving Neoadjuvant Treatment
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- 1 The presence of viable tumor cells at the margins and in the mastectomy specimen after conducted breast preserving resection followed by mastectomy in the same procedure
研究概览
简要总结
The study explores the safety of breast conserving treatment (BCT)(defined as complete removal of tumor deposits) after neoadjuvant treatment for locally advanced breast cancer.
详细描述
The standard breast surgical procedure of locally advanced breast cancer in Norway is mastectomy. There is increasing interest in performing breast conserving treatment (BCT) in locally advanced cases after chemotherapy or hormonal treatment - if there is a partial or complete clinical remission. To increase the evidence for the safety (no residual tumor) of such a procedure directly compared to mastectomy without compromising the safety of the treatment, a breast preserving procedure followed by an immediate mastectomy can be performed within a study. It would then be possible to study the margins after the breast preserving procedure as well as the tumor status in the rest of the breast.
Patients included in the study will receive neoadjuvant treatment followed by evaluation of the tumor reduction by magnetic resonance imaging (MRI) and selection of BCT candidates. Candidates will be prepared for BCT, and during the surgical procedure, BCT will be performed (as one surgical specimen) followed by immediate removal of the rest of the breast tissue (mastectomy). The BCT specimen and mastectomy specimen will be analysed for residual tumor cells. The tumor removal completeness of the BCT procedure can be evaluated, with comparison to the clinical and primary tumor characteristics, including analysis of the tumor biopsies and imaging before and during the neoadjuvant treatment, for selection of candidates for BCT in the future.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
1 The presence of viable tumor cells at the margins and in the mastectomy specimen after conducted breast preserving resection followed by mastectomy in the same procedure
时间窗: 24 weeks after start of neoadjuvant treatment (at surgery)
The surgical specimens will be analysed after surgery, and the results of these analyses will be the basis for the final end point measurements.
次要结局
- Tumor molecular marker characteristics related to complete resection by BCT(24 weeks after start of neoadjuvant treatment (at surgery))
研究者
Bjørn Naume
Principal investigator
Oslo University Hospital
