Nab-paclitaxel Based Regimens VS Paclitaxel Based Regimens in Neoadjuvant Treatment for TNBC
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|ClinicalTrials.gov Identifier: NCT04067102|
Recruitment Status : Withdrawn (No patients recruited)
First Posted : August 26, 2019
Last Update Posted : July 9, 2021
|Condition or disease||Intervention/treatment||Phase|
|Triple Negative Breast Cancer||Drug: Albumin bound (nab)-paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide Drug: paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Actual Study Start Date :||May 10, 2019|
|Estimated Primary Completion Date :||May 2021|
|Estimated Study Completion Date :||May 2026|
|Experimental: Nab-paclitaxel Based Regimens||
Drug: Albumin bound (nab)-paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide
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
|Active Comparator: Paclitaxel Based Regimens||
Drug: paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide
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
- pathologic complete response（pCR） [ Time Frame: 6 months ]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)
- Objective Response Rate (ORR) [ Time Frame: 3 months ]Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)
- Disease-free survival（DFS） [ Time Frame: 5 years ]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.
- Overall survival（OS） [ Time Frame: 5 years ]Overall survival is defined as the length of time from random assignment to death or to last contact.
- adverse events（AEs） [ Time Frame: until 28 days after the last study drug administration ]AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.03.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04067102
|Fourth Hospital of Hebei Medical University|
|Shijiazhuang, Hebei, China, 050011|
|Principal Investigator:||Yunjiang Liu, MD||Hebei Medical University Fourth Hospital|