Primary Operation in SYnchronous meTastasized InVasivE Breast Cancer, a Multicenter Prospective Randomized Study to Evaluate the Use of Local Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 28
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
Primary Operation in synchronous metastasized invasive breast cancer to evaluate the use of local therapy
详细描述
This study is a prospective, randomized, multicentre, study concerning the influence of local treatment on the patients with synchronous metastasized breast cancer. Patients will be stratified at inclusion according to the centre, the menopausal status (pre-menopausal, post-menopausal), the hormone-receptor status (ER-/PR-/not determinable; any PR and/or Er+), the HER-2 status (positive vs. negative/not determinable), the grading (G1/G2/not determinable vs. G3), location of metastases (visceral ± vs bone only), organs with metastases (single organ vs multiple organs) and use of first line chemotherapy (anthracycline ± vs. taxane vs others). Thereafter patients will be randomly assigned to receive either local therapy of the breast (lumpectomy or mastectomy + axillary surgery /± radiotherapy) versus no local therapy. Systemic therapy will be administered at the centers policy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Patients age ≥ 18 years
- •Eastern Cooperative Oncology Group Performance Status is 0 -2
- •Untreated synchronous metastasized invasive carcinoma of the breast with the primary tumor in situ (bilateral synchronous metastasized breast cancer patients are eligible)
- •The primary tumor must be identified and may be any size, however, primary resection with resection free margins must be possible
- •Invasive adenocarcinoma of the breast on histological examination
- •The metastatic site must be identified by radiological assessment(Computer Tomography of the chest and the abdomen OR ultrasound and chest x ray for visceral metastases; bone scan AND/OR computer tomography AND/OR magnetic resonance for bone metastases). A biopsy is not necessary.
- •Written informed consent must be obtained and documented prior to beginning any protocol specific procedures and according to local regulatory requirements
- •able to comply with the protocol requirements during the treatment and follow-up period.
排除标准
- •Patients in whom a R0 resection (microscopic free margins) is clinically questionable
- •Inflammatory cancer
- •Patients with a brain metastasis
- •Patients who are not eligible for general anesthesia and operations
- •Patients without metastatic breast cancer (patients with a tumor marker value (CEA, CA15-3) above normal levels without the radiological proven evidence of metastases are not eligible for the study)
- •Patients with a second untreated malignancy
- •Any previous malignancy treated with curative intent and the patient has not been disease-free for 5 years - exceptions are: (a)carcinoma in situ of the cervix, (b)squamous carcinoma of the skin, (c)basal cell carcinoma of the skin
- •Patients with any recurrent cancer disease
- •Pregnant or lactating women
- •Patients are not allowed to be part of another local therapy trial
结局指标
主要结局
Overall Survival (OS)
时间窗: Time from randomization until the last visit of the last participant; maximum time on study was 63.9 months
Overall Survival with vs without local therapy (surgery)
次要结局
- Time to Distant Progression(Time from randomization until the last visit of the last participant; maximum time on study was 63.9 months)
- Time to Local Progression (TTPl)(Time from randomization until the last visit of the last participant; maximum time on study was 63.9 months)