Radical Local vs. Palliative Therapy for Breast Cancer Patientts With Ipsilateral Humerus or Sternum Oligometastasis
Recruiting · NCT04158843 · Interventional (participants receive a specific treatment) · Lead sponsor: xuexin he
View the official record on ClinicalTrials.gov →Interventions studied
Palliative treatmentRadical radiotherapyRadical resection
What this trial is about
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
Who can take part
Age range
18 Years to 75 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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.
Where it is running
4 locations listed.
- Institute of Cancer Research and Basic Medical Sciences, CAS Cancer Hospital, University of Chinese Academy of Sciences Zhejiang Cancer Hospital - Hangzhou, Zhejiang, China
- The Second Affiliated Hospital of Zhejiang University School of Medicine (SAHZU) - Hangzhou, Zhejiang, China
- Jiaxing Second Hospital - Jiaxing, Zhejiang, China
- The Central Hospital of Lishui - Lishui, Zhejiang, China