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In clinical treatment, most patients with stage IV breast cancer received surgical treatment, which made it difficult to enroll this project, so this study was terminated.
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The purpose of this study is to compare the effect of primary resection combined with systemic therapy and pure systemic therapy on the overall survival of patients with stage â…£ breast cancer.
In developing countries, the proportion of breast cancer patients who have a stage IV diagnosis at the first diagnosis can be as high as 25%. For advanced breast cancer, previous views have suggested that surgery as one of the palliative treatments does not improve patient survival. The proportion of patients undergoing surgery for stage IV breast cancer has gradually decreased over the past 30 years. At present, there is still no clear recommendation and guidance in common clinical guidelines for the primary surgery for stage IV breast cancer. Some retrospective studies suggest that surgery can improve the survival of advanced breast cancer, but the results of prospective studies are inconclusive, and surgery is still not a routine choice for stage IV breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| surgery combined with systemic therapy | Experimental | surgery combined with systemic therapy |
|
| systemic therapy | Active Comparator | systemic therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| surgery combined with systemic therapy | Combination Product | surgery combined with systemic therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| OS | The time from diagnosis to death | up to 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | The time from randomization to disease progression or death, including local PFS and distant PFS Local PFS refers to the time from randomization of patients to local or regional lymph node recurrence in the surgical group or local or regional lymph node progression in the non-surgical group. distant PFS refers to the time from randomization of a patient to local or distant distant disease progression or death. |
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Inclusion Criteria:
• Sign the informed consent
Histologically diagnosed invasive breast cancer, measure distant metastases with local standard assessment methods;
Known hormone receptors and HER-2 status (ER, PR and HER2);
Exclusion Criteria:
• Double breast cancer;
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| Name | Affiliation | Role |
|---|---|---|
| Jiujun Zhu | Henan Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Cancer Hospital | Zhengzhou | Henan | 450008 | 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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| systemic therapy | Other | systemic therapy |
|
| up to 2 year |
| BCSS (Breast Cancer Specific Survival) | The time from the random start of a patient to death due to breast cancer, excluding deaths caused by other causes | up to 2 year |
| D017437 |
| Skin and Connective Tissue Diseases |