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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

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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: 3 months ]
    Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Yunjiang Liu, MD +86-311-6669-6220 lyj818326@126.com

Locations
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China, Hebei
Fourth Hospital of Hebei Medical University Recruiting
Shijiazhuang, Hebei, China, 050011
Contact: Yunjiang Liu, MD         
Principal Investigator: Yunjiang Liu, MD         
Sponsors and Collaborators
Hebei Medical University Fourth Hospital
Investigators
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Principal Investigator: Yunjiang Liu, MD Hebei Medical University Fourth Hospital
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Responsible Party: Liu Yunjiang, Professor, Director and Vice-president, Hebei Medical University Fourth Hospital
ClinicalTrials.gov Identifier: NCT04067102    
Other Study ID Numbers: TNBC-NEO
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Cyclophosphamide
Carboplatin
Epirubicin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors