Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04067102
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Liu Yunjiang, Hebei Medical University Fourth Hospital

Tracking Information
First Submitted Date  ICMJE August 14, 2019
First Posted Date  ICMJE August 26, 2019
Last Update Posted Date August 26, 2019
Actual Study Start Date  ICMJE May 10, 2019
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2019)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2019)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nab-paclitaxel Based Regimens VS Paclitaxel Based Regimens in Neoadjuvant Treatment for TNBC
Official Title  ICMJE 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)
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Triple Negative Breast Cancer
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Nab-paclitaxel Based Regimens
    Intervention: Drug: Albumin bound (nab)-paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide
  • Active Comparator: Paclitaxel Based Regimens
    Intervention: Drug: paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 21, 2019)
224
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2026
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yunjiang Liu, MD +86-311-6669-6220 lyj818326@126.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04067102
Other Study ID Numbers  ICMJE TNBC-NEO
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Liu Yunjiang, Hebei Medical University Fourth Hospital
Study Sponsor  ICMJE Hebei Medical University Fourth Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yunjiang Liu, MD Hebei Medical University Fourth Hospital
PRS Account Hebei Medical University Fourth Hospital
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP