A Randomized, Open Label Trial to Evaluate Radical Local Treatment Versus Palliative Treatment for Breast Cancer Patients With Ipsilateral Humerus or Sternum Oligometastasis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 183
- 试验地点
- 4
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
A Randomized, Open Label, Phase III Trial to Evaluate Radical Local Treatment versus Palliative Treatment for Breast Cancer Patients with Primary Ipsilateral Humerus or Sternum Oligometastasis
详细描述
This is a prospective, randomized, and multicenter study to compare the radical local treatment versus palliative treatment for breast cancer patients with primary ipsilateral humerus or sternum oligometastasis.
183 subjects will be randomized divided into two groups (experimental group and control group) at a ratio of 2 to 1.
Control group: Palliative treatment. No radical surgical resection or radiotherapy is performed in this group. But palliative internal fixation or radiotherapy for pain relief is permitted. Moreover, systemic chemotherapy, endocrine therapy and targeted therapy are allowed.
Experimental group：Radical local treatment. Radical resection is performed, and the cutting edge is negative, or radical local radiotherapy is feasible (cumulative radiotherapy dose is greater than or equal to 50Gy). Systemic endocrine therapy and targeted therapy are allowed after radical local therapy. However, whether systemic chemotherapy should be used is determined by clinicians according to clinical experience or guidelines.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •* Patients provided written informed consent
- •* Women aged 18-75 years old
- •* Histologically confirmed breast cancer and after radical mastectomy
- •* Patients of breast cancer with ipsilateral humerus or sternum oligometastasis, and there is no imaging evidence of other site metastases
- •* Patients must have recovered to baseline condition or to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade = 1 from any acute CTCAE v. 5.0 grade =2 side effects of previous treatments
- •* Without infection of human immunodeficiency virus (HIV) on central laboratory assay results prior to randomization
- •* Alanine aminotransferase (ALT) \/= 30g/L
- •* Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2
- •* Women of child-bearing age should take effective contraceptive measures
- •* Serum total bilirubin (TBil) \/= 3×109/L, Blood neutrophil count \>/= 1.5×109/L, Platelet count \>/= 100×109/L, Hemoglobin (HB) \>/= 9 g/dL
排除标准
- •Without radical mastectomy of the primary breast lesions
- •No radical resection or radiotherapy is possible for metastatic lesions
- •Other site metastases except ipsilateral humerus or sternum are present
- •With multiple metastatic lesions
- •Any other current malignancy or malignancy diagnosed within the past five years (other than carcinoma in situ or stage Ia carcinoma of the cervix, skin basal cell carcinoma and papillary thyroid carcinoma at early stage)
- •Active infection with human immunodeficiency virus (HIV) prior to first study treatment administration.
- •History of participating any other clinical trials within 30 days prior to randomization
- •Known unable to tolerate humerus or sternal surgery or radical radiotherapy
- •Pregnancy or lactation
- •Current severe systemic disease (for example, clinically significant cardiovascular, pulmonary, or renal disease)
- •Legal incompetence or limitation.
- •Considered unable to complete the study or sign the informed consent due to a medical or mental disorder by the investigator.
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: 4 years
PFS is defined as time from randomization to disease progression or death, whichever occurs first
次要结局
- Overall Survival (OS)(4 years)
- Patient Reported Outcomes(4 years)
研究者
xuexin he
Associate chief physician
Second Affiliated Hospital, School of Medicine, Zhejiang University