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To evaluate the efficacy and safety of P nab-paclitaxel combined with carboplatin versus paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide in the neoadjuvant treatment of triple negative breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nab-paclitaxel Based Regimens | Experimental |
| |
| Paclitaxel Based Regimens | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albumin bound (nab)-paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide | Drug | Paclitaxel for injection (albumin binding)260mg/m2,I.v., d1;carboplatin AUC=5, I.v., d1; 21 days in one cycle, 4 cycles in total.Continue the protocol when evaluated as CR/PR/SD at the second cycle, Terminate the protocol paclitaxel (albumin binding) combined with carboplatin when evaluated as PD at the second cycle,and use the EC protocol in advance or decide the next treatment |
| Measure | Description | Time Frame |
|---|---|---|
| pathologic complete response(pCR) | pCR is defined as no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or sentinel node identified after neoadjuvant chemotherapy (ypT0/Tis ypN0) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR) | 3 months |
| Disease-free survival(DFS) | Disease-free survival refers to the time from surgical resection of breast cancer to clinically confirmed local recurrence, distant metastasis, second primary tumor diagnosis, or patient death. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yunjiang Liu, MD | Hebei Medical University Fourth Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fourth Hospital of Hebei Medical University | Shijiazhuang | Hebei | 050011 | China |
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| paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide | Drug | Paclitaxel 175mg/m2, I.v., d1; Carboplatin injection AUC 5, I.v., d1; 21 days in one cycle, 4 cycles in total.Continue the protocol when evaluated as CR/PR/SD at the second cycle, Terminate the protocol paclitaxel (albumin binding) combined with carboplatin when evaluated as PD at the second cycle,and use the EC protocol in advance or decide the next treatment protocol by the researcher |
|
| 5 years |
| Overall survival(OS) | Overall survival is defined as the length of time from random assignment to death or to last contact. | 5 years |
| adverse events(AEs) | AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.03. | until 28 days after the last study drug administration |
| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
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