A Randomized, Open Label Trial to Evaluate Radical Local Treatment Versus Palliative Treatment for Breast Cancer Patients With Ipsilateral Humerus or Sternum Oligometastasis

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other, Procedure, Radiation
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Institute of Cancer Research and Basic Medical Sciences, CAS Cancer Hospital, University of Chinese Academy of Sciences Zhejiang Cancer Hospital
NOT_YET_RECRUITING
Hangzhou
The Second Affiliated Hospital of Zhejiang University School of Medicine (SAHZU)
RECRUITING
Hangzhou
Jiaxing Second Hospital
NOT_YET_RECRUITING
Jiaxing
The Central Hospital of Lishui
NOT_YET_RECRUITING
Lishui
Contact Information
Primary
xuexin he, MD
xuexinhe@zju.edu.cn
+86-18329139569
Time Frame
Start Date: 2020-05-09
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 183
Treatments
Experimental: 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.
Active_comparator: Palliative treatment
No radical surgical resection or 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.
Related Therapeutic Areas
Sponsors
Leads: xuexin he

This content was sourced from clinicaltrials.gov