Nab-paclitaxel Based Regimens VS Paclitaxel Based Regimens in Neoadjuvant Treatment for TNBC

Study Overview
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Brief Summary
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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.

Official Title
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Albumin Bound (Nab)-Paclitaxel Combined With Carboplatin Versus Paclitaxel Combined With Carboplatin Followed by Epirubicin and Cyclophosphamide as Neoadjuvant Treatment for Participants With Triple Negative Breast Cancer (TNBC)

Conditions
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Triple Negative Breast Cancer

Intervention / Treatment
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* Drug: Albumin bound (nab)-paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide
* Drug: paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female, aged ≥ 18 yrs and ≤70 yrs； Histological confirmation of Unilateral primary invasive breast cancer, cT2-4NanyM0, planning to receive neoadjuvant chemotherapy； The expression of ER<10%，PR <10% and Her-2 negative by immunohistochemical, if HER2 expression ++, further FISH test confirmed no amplification of Her-2 gene； ECOG performance status 0-1； LVEF≥55%； Bone marrow function: neutrophils ≥ 1.5×109/L, platelets ≥ 100×109/L, hemoglobin ≥ 90 g/L； Liver and renal function：Serum creatinine ≤ 1.5x ULN；Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5x ULN；Total bilirubin ≤ 1.5x ULN or when patients with Gilbert's syndrome ≤ 2.5x ULN； The patient has good compliance with the planned treatment, understands the research process of the study and signs a written informed consent form. Exclusion Criteria: Cytotoxic chemotherapy, endocrine therapy or radiation therapy for any reason； New York Heart Association (NYHA) score identifies patients with heart disease above grade II (including grade II)； Patients with severe systemic infections or other serious illnesses； Patients known to be allergic or intolerant to chemotherapeutic drugs or their excipients； Combined with other malignant tumors or had malignant tumors other than breast cancer in the past 5 years, except for cervical carcinoma in situ and non-melanoma skin cancer that have been fully treated； Women of childbearing age who are pregnant or lactating and who refuse to take appropriate contraceptive measures during the trial； Participated in other experimental studies within 30 days before the first dose of study drug administration Researchers judged patients who were unsuitable for this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nab-paclitaxel Based Regimens<br> | Drug: Albumin bound (nab)-paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide<br>* 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<br>|
| Active Comparator: Paclitaxel Based Regimens<br> | Drug: paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |