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The goal of this clinical trial is to compare the therapeutic effects of chemotherapy followed by surgery and surgery followed by chemotherapy in patients with locally advanced breast cancer(LABC). Patients with LABC will be randomly divided into two groups, each receiving chemotherapy followed by surgery or surgery followed by chemotherapy. The main comparison was between the disease-free survival (DFS) of two groups of patients, with the secondary study endpoint being overall survival (OS); Five year survival; Local recurrence or distant metastasis rate.
Local advanced breast cancer was enrolled in the Department of Breast Surgery of Peking Union Medical College Hospital and Beijing Cooperation Hospital according to the criteria for patient inclusion. It is estimated that 50 patients will be enrolled. Randomly divide patients into two groups. The plan for Group A (experimental group, 25 cases) is "surgery+systematic treatment"; The plan for Group B (control group, 25 cases) is "neoadjuvant therapy+surgery+systematic treatment". Based on the previously obtained patient personal information, treatment related information, tumor tissue/blood sample test results, statistical analysis was conducted to explore the impact of different treatment strategies for locally advanced breast cancer on the survival and prognosis of patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Surgery+systematic treatment |
|
| Group B | Active Comparator | Neoadjuvant therapy+surgery+systematic treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified radical mastectomy for breast cancer | Procedure | Modified radical mastectomy for breast cancer |
|
| Measure | Description | Time Frame |
|---|---|---|
| DFS | Disease-free survival of patients with locally advanced breast cancer | 1 year;3 years;5 years |
| Measure | Description | Time Frame |
|---|---|---|
| OS | Overall survival of patients with locally advanced breast cancer | 1 year;3 years;5 years |
| Five year survival rate | Five year survival rate of patients with locally advanced breast cancer |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Xu | Contact | +861069158721 | xuying@pumch.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yan Lin | Peking Union Medical College Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ying Xu | Recruiting | Beijing | 100730 | China |
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| ID | Term |
|---|---|
| D015411 | Mastectomy, Modified Radical |
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D015409 | Mastectomy, Radical |
| D008408 | Mastectomy |
| D013514 | Surgical Procedures, Operative |
| D003131 | Combined Modality Therapy |
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The plan for Group A (experimental group) is "surgery+systematic treatment"; The plan for Group B (control group) is "neoadjuvant therapy+surgery+systematic treatment".
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| neoadjuvant therapy | Procedure | neoadjuvant chemotherapy(Drugs:" Doxorubicin""Paclitaxel""Albumin paclitaxel""Cyclophosphamide"), endocrine therapy(Drugs:"Toremifen""Zoladex""Aromatase inhibitors"), targeted therapy(Drugs:"trastuzumab""Pertuzumab") |
|
| Systematic treatment | Procedure | chemotherapyDrugs:" Doxorubicin""Paclitaxel""Albumin paclitaxel""Cyclophosphamide"), endocrine therapy(Drugs:"Toremifen""Zoladex""Aromatase inhibitors"), targeted therapy(Drugs:"trastuzumab""Pertuzumab"),radiotherapy("Yikeda Versa HD linear accelerator""Varian Trilogy linear accelerator") |
|
| 1 year;3 years;5 years |
| Local recurrence or distant metastasis rate | Local recurrence or distant metastasis rate of patients with locally advanced breast cancer | 1 year;3 years;5 years |
| D013812 | Therapeutics |