Post-Mastectomy Radiation Therapy in High Risk, Node Negative Women With Early Breast Cancer (PMRT-NNBC)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,022
- 试验地点
- 14
- 主要终点
- Disease free survival
研究概览
简要总结
Postmastectomy radiotherapy (PMRT) is unequivocally beneficial in reducing the recurrences as well as improving survival in node positive breast cancer patients. PMRT for women with T1-T2 tumors and negative axillary nodes is not generally warranted because of the presumed low risk of recurrence in this population as a whole. However, in the setting of multiple adverse prognostic factors, the recurrence risk approaches and in some cases surpasses the risk of recurrence documented for patients with one to three positive lymph nodes. Numerous retrospective series have reported the outcome and patterns of failure for post-mastectomy patients treated without radiation. Many of these series have analyzed several high risk factors which were predictive of loco-regional recurrence wherein the role of adjuvant post-mastectomy radiation can be considered. Some authors have used combinations of prognostic factors, such as age, tumour size, grade, receptor status, Her2neu status and lympho-vascular space invasion to define subgroups with more specific risks of loco-regional recurrence than single factors alone. The current trial hypothesizes that "Post-mastectomy radiation in high risk, node negative early breast cancer patients decreases rates of loco-regional recurrence and improves disease free survival" and propose to address the question in randomized setting.
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with unilateral pT1,2N0M0 breast cancer or multifocal breast cancer if largest discrete tumour at least 2cm or if the tumour area comprises multiple small adjacent foci of invasive carcinoma then overall maximum dimension taken. This must be greater than 2cm.
- •Upfront total mastectomy (with minimum 1 mm margin clear of invasive cancer or DCIS) and axillary staging procedure (clearance, sampling or SNB)
- •T2 tumors with one risk factor or T1 tumors with any of the following two high risk factors such as presence of high grade, lymphovascular invasion, ER/PR negative, HER2 positivity, age < 35 years.
- •Fit to receive adjuvant radiation +/- chemotherapy (if indicated) +/- hormonal therapy (if indicated)
- •Written, informed consent
排除标准
- •Any pTis/3/4, M1 patients
- •Patients who have any pathologically involved axillary nodes (micro-metastasis may be allowed)
- •Patients who have undergone neoadjuvant systemic therapy.
- •Previous or concurrent malignancy other than non melanomatous skin cancer and carcinoma in situ of the cervix
- •Pregnancy
- •Bilateral breast cancer
- •Not fit for surgery, radiotherapy or adjuvant systemic therapy
- •Unable or unwilling to give informed consent
结局指标
主要结局
Disease free survival
时间窗: 5 years
This will be measured using Kaplan Meier time to event analysis
次要结局
- Regional recurrence(5 years)
- Acute Morbidity of radiotherapy(4 weeks from the start of radiotherapy)
- Chest wall recurrence(5 years)
- Metastasis-free survival(5 years)
- Overall survival(5 years)
- Late Morbidity of radiotherapy(6 months from end of radiotherapy to 5 years)
- Quality of life scores under different domains of the QLQ C-30 and BR-23 questionnaires(5 years post surgery)
研究者
Dr. Tabassum Wadasadawala
Associate Professor, Radiation Oncology
Tata Memorial Centre