Radical Local vs. Palliative Therapy for Breast Cancer Patientts With Ipsilateral Humerus or Sternum Oligometastasis
NCT ID: NCT04158843
Last Updated: 2020-05-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
183 participants
INTERVENTIONAL
2020-05-09
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Radical resection
Radical resection is performed, and the cutting edge is negative.
Radical radiotherapy
Radical local radiotherapy is feasible (cumulative radiotherapy dose is greater than or equal to 50Gy).
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.
Palliative treatment
Including palliative internal fixation, radiotherapy, systemic chemotherapy, endocrine therapy or targeted therapy
Interventions
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Radical resection
Radical resection is performed, and the cutting edge is negative.
Radical radiotherapy
Radical local radiotherapy is feasible (cumulative radiotherapy dose is greater than or equal to 50Gy).
Palliative treatment
Including palliative internal fixation, radiotherapy, systemic chemotherapy, endocrine therapy or targeted therapy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
FEMALE
No
Sponsors
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xuexin he
OTHER
Responsible Party
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xuexin he
Associate chief physician
Principal Investigators
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Xiaobo Yan, MD
Role: STUDY_DIRECTOR
The Second Affiliated Hospital of Zhejiang University School of Medicidne
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Gu Jin, MD
Role: primary
Xiaobo Yan, MD
Role: primary
xuexin he, MD
Role: backup
Zhenhai Cai, MD
Role: primary
Xiaoguang Wu, MD
Role: primary
Other Identifiers
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BOMB
Identifier Type: -
Identifier Source: org_study_id
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