Disease free survival rates of Breast Conservation and modified radical mastectomy following neoadjuvant therapy in locally advanced breast cancer patients with skin involvement (T4b): A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- To evaluate disease free survival rates of breast conservation and modified radical mastectomy following neoadjuvant chemotherapy in locally advanced breast cancer patients with skin involvement
研究概览
简要总结
BRECON-T4b trial aims to determine whether breast conservation surgery (BCS), traditionally reserved for early breast cancers, can be a safe and effective alternative to modified radical mastectomy (MRM) in patients with locally advanced breast cancer with skin involvement (T4b), who have responded to neoadjuvant chemotherapy (NACT). It seeks to answer whether disease-free survival (DFS), ipsilateral breast tumor recurrence (IBTR), and overall survival (OS) of BCS are comparable to MRM in this subgroup. This trial challenges the long-held belief that mastectomy is mandatory in T4b breast cancers by prospectively comparing BCS and MRM, whether less radical surgery is oncologically safe.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Female
入选标准
- •Breast cancer patients with skin involvement (T4b) who have responded (complete, partial, and stable disease) to NACT (response assessed using the RECIST 1.1 criteria).
- •Patients willing to consent for the study.
排除标准
- •Progressive disease after NACT
- •Supraclavicular nodes (N3 disease)
- •Fixed axillary nodes
- •Metastatic disease(M1 disease)
- •Poor general conditions with ECOG score of 2 or more precluding NACT or surgery or radiation with a known history of liver .cardiac and renal disease.
结局指标
主要结局
To evaluate disease free survival rates of breast conservation and modified radical mastectomy following neoadjuvant chemotherapy in locally advanced breast cancer patients with skin involvement
时间窗: Three years
次要结局
- To evaluate overall survival and ipsilateral breast tumor recurrence rates between the two surgical approaches(Three years)
- To assess postoperative complications (30-day morbidity) using the Clavien-Dindo scoring system(30 days)
- To study the pathological outcomes of these patients(30 days)
研究者
Dr Ephraim Rebba
AIIMS PATNA