Systemic Therapy With or Without Up Front Surgery of the Primary Tumor in Breast Cancer Patients With Distant Metastases at Initial presenTation
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 26
- 主要终点
- Survival
研究概览
简要总结
SUBMIT is a clinical trial that intends to answer the question whether up front breast surgery in patients with primary distant metastatic breast cancer will result in an improvement of the 2-year survival compared to the survival achieved with systemic therapy and delayed local treatment or systemic therapy alone.
Randomization will take place immediately after the diagnosis of primary distant metastatic breast cancer. Patients either randomize for up front surgery of the breast tumor (UFS) followed by systemic therapy or for systemic therapy (ST) potentially followed by delayed local treatment of the breast tumor.
The primary endpoint of this trial is the 2-years survival. Quality of life is one of the most important secondary endpoints.
详细描述
In the Netherlands approximately one out of eight women will be diagnosed with breast cancer; 5% have metastatic disease at presentation. Because metastatic breast cancer is considered to be an incurable disease, it is only treated with a palliative intent. Recent retrospective studies have demonstrated that (complete) resection of the primary tumor significantly improves the outcome of patients with primary metastatic breast cancer. However, other studies showed that the survival benefit in patients who underwent surgery is caused by selection bias.
SUBMIT is a clinical trial that intends to answer the question whether up front breast surgery in patients with primary distant metastatic breast cancer will result in an improvement of the 2-year survival compared to the survival achieved with systemic therapy and delayed local treatment or systemic therapy alone.
Patients to submit in this study are patients with primary distant metastatic breast cancer, with no prior treatment of the breast cancer, who are 18 years or older and fit enough to undergo surgery and systemic therapy. Exclusion criteria are: history of breast cancer, other malignancy within the last 10 years, surgical treatment or radiotherapy of this breast tumor before randomization, irresectable T4 tumor or synchronous bilateral breastcancer.
Randomization will take place immediately after the diagnosis of primary distant metastatic breast cancer. Patients either randomize for up front surgery of the breast tumor (UFS) followed by systemic therapy or for systemic therapy (ST) potentially followed by delayed local treatment of the breast tumor.
The primary endpoint of this trial is the 2-years survival. Quality of life is one of the most important secondary endpoints.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed primary distant metastatic breast cancer (M1)
- •Anticipated survival of at least 6 months
- •Histologically proven breast cancer
- •Hormonal and HER2Neu status should be known
- •T1-T3, resectable T4 status, N0-N3
- •Performance status of the patient should allow surgery / systemic therapy
- •Co-morbidity of the patient should allow surgery / systemic therapy
- •Age > 18 years
- •Written informed consent
排除标准
- •Primary invasive breast cancer in medical history
- •Other malignancy within the last 10 years, besides basal cell carcinoma of the skin or early stage cervical cancer
- •Surgical treatment / radiotherapy of this breast tumor before randomization
- •Irresectable T4 breast tumor
- •Synchronous bilateral breast cancer
结局指标
主要结局
Survival
时间窗: participants will be followed until death (expected median survival 31 months for surgery group)
Survival is defined in months from the time of randomization until death. Overall survival will be expressed as the median survival in months.
次要结局
- Quality of Life(5 years after randomisation)
- Two year survival(2 yrs after randomisation)
- Number of unplanned local therapies(5-6 months after randomisation)
- Difference in systemic therapy given(6 months after randomisation)
- Determination of pathological resection margin(Pathological report approximately 1 day after surgery)
- Number of treatments of the axillary lymph nodes(6 months after randomisation)
研究者
M.F. Ernst, dr
Dr.M.F.Ernst
Jeroen Bosch Ziekenhuis