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

Sponsor
Hebei Medical University Fourth Hospital (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04067102
Collaborator
(none)
0
1
2
83.7
0

Study Details

Study Description

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
  • Drug: Albumin bound (nab)-paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide
  • Drug: paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
0 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
Anticipated Primary Completion Date :
May 1, 2021
Anticipated Study Completion Date :
May 1, 2026

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. pathologic complete response(pCR) [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) [3 months]

    Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)

  2. Disease-free survival(DFS) [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) [5 years]

    Overall survival is defined as the length of time from random assignment to death or to last contact.

  4. adverse events(AEs) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fourth Hospital of Hebei Medical University Shijiazhuang Hebei China 050011

Sponsors and Collaborators

  • Hebei Medical University Fourth Hospital

Investigators

  • Principal Investigator: Yunjiang Liu, MD, Hebei Medical University Fourth Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Aug 26, 2019
Last Update Posted:
Jul 9, 2021
Last Verified:
Jul 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 9, 2021