A Randomized, Open Label Trial to Evaluate Radical Local Treatment Versus Palliative Treatment for Breast Cancer Patients With Ipsilateral Humerus or Sternum Oligometastasis
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
• 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) \</= 2.5 × the upper limit of normal (ULN), Aspartate aminotransferase (AST) \</= 2.5 × ULN prior to randomization
• Total bilirubin (TBIL) \</= 1.25 × ULN
• Alkaline phosphatase (ALK) \</= 2.5 × ULN
• Gamma glutamyl transpeptidase (GGT) \</= 2.5 × ULN
• Albumin \>/= 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) \</= 1.5 × ULN
• Serum creatinine (Scr) \</= 1.5 × ULN
• White blood cell count (WBC) \>/= 3×109/L, Blood neutrophil count \>/= 1.5×109/L, Platelet count \>/= 100×109/L, Hemoglobin (HB) \>/= 9 g/dL