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This is a phase IV, single-center, prospective, open-label, randomized,controlled study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy | Experimental |
| |
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vinorelbine | Drug | different from primary chemotherapy(containing anthracycline or paclitaxel) |
|
| Measure | Description | Time Frame |
|---|---|---|
| distant disease-free survival (DDFS) | 5 years after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| relapse-free survival(RFS)、overall survival(OS) | 5 years after surgery |
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Inclusion Criteria:
Female patients, 18≦age ≦66 years
Biopsy proven lymph node positive, estrogen receptor<10%、progesterone receptor <10% and human epidermal growth factor receptor-2 negative primary breast cancer
Must have completed neo-adjuvant chemotherapy with a standard regimen(containing both anthracycline and paclitaxel)
Must have undergone surgery to remove the primary tumor by either a mastectomy or enlarged local excision
Postoperative residual positive lymph nodes
Adequate recovery from recent surgery
No history of other malignancies
No currently uncontrolled diseased or active infection
Not pregnant or breast feeding, and on appropriate birth control if of child-bearing potential
Adequate cardiovascular function reserve with a myocardial infarction within the past six month
without radiotherapy and chemotherapy contraindication
Adequate hematologic function with:
Adequate hepatic and renal function with:
Knowledge of the investigational nature of the study and Ability to give informed consent
Ability and willingness to comply with study procedures.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xing Wang, MD | Contact | 0086-10-88271119 | 8018 | wangxing_susu@sina.com |
| Ying-jian He, MD | Contact | 0086-10-88271119 | 8018 | mimi487@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xing Wang, MD | Peking University Cancer Hospital & Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39604957 | Derived | Wang X, He Y, Li J, Wang T, Fan Z, Ouyang T. Intensive treatment of triple negative breast cancer with residual positive axillary lymph node after neoadjuvant chemotherapy. BMC Womens Health. 2024 Nov 27;24(1):629. doi: 10.1186/s12905-024-03441-0. |
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| ID | Term |
|---|---|
| D000077235 | Vinorelbine |
| ID | Term |
|---|---|
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
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