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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radical local treatment | Experimental | 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. |
|
| Palliative treatment | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radical resection | Procedure | Radical resection is performed, and the cutting edge is negative. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | PFS is defined as time from randomization to disease progression or death, whichever occurs first | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is defined as time from randomization to death for any cause. If there is no death reported for a subject before the date cutoff for OS analysis, OS will be censored at the last contact date at which the subject is known to be alive. For patients who had not died up to the cut-off date, the date they were last known to be alive was derived from the patient status records, the trial completion record, radiological imaging assessments, the study treatment termination record, and the randomization date. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| xuexin he, MD | Contact | +86-18329139569 | xuexinhe@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xiaobo Yan, MD | The Second Affiliated Hospital of Zhejiang University School of Medicidne | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Cancer Research and Basic Medical Sciences, CAS Cancer Hospital, University of Chinese Academy of Sciences Zhejiang Cancer Hospital | Not yet recruiting | Hangzhou | Zhejiang | 310000 | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Radical radiotherapy | Radiation | Radical local radiotherapy is feasible (cumulative radiotherapy dose is greater than or equal to 50Gy). |
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| Palliative treatment | Other | Including palliative internal fixation, radiotherapy, systemic chemotherapy, endocrine therapy or targeted therapy |
|
| 4 years |
| Patient Reported Outcomes | Breast cancer specific health treatment related quality of life and general health status (Functional Assessment of Cancer Therapy-Breast (FACT-B) [version 4]) | 4 years |
|
| The Second Affiliated Hospital of Zhejiang University School of Medicine (SAHZU) | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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| Jiaxing Second Hospital | Not yet recruiting | Jiaxing | Zhejiang | 314000 | China |
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| The Central Hospital of Lishui | Not yet recruiting | Lishui | Zhejiang | 323000 | China |
|
| D017437 |
| Skin and Connective Tissue Diseases |