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Neoadjuvant Chemotherapy With Pyrotinib, Epirubicin and Cyclophosphamide Followed by Taxanes and Trastuzumab for HER-2+ Breast Cancer

Primary Purpose

Breast Cancer

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Pyrotinib
Epirubicin
Cyclophosphamide
Taxanes
Trastuzumab
Sponsored by
Hebei Medical University Fourth Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Female breast cancer patients at the age of >= 18 years and <= 65 years who received first treatment；
  2. Pathologically confirmed HER2-positive invasive breast cancer（which is defined as the immunohistochemistry score of > 10% immunoreactive cells being 3+ or in situ hybridization results showing HER2 gene amplification），regardless of hormone receptor status (ER and PR)；
  3. According to the 2019 CSCO BC guidelines: When HER-2 positive is used as the standard for preoperative neoadjuvant therapy for breast cancer, the tumor is larger than 2 cm；
  4. The Eastern Tumor Collaborative Group (ECOG) has a physical status score of ≤1；
  5. The functional level of the main organs must meet the following requirements ： 1) blood routine test: hemoglobin (Hb) ≥ 90g/L;Neutrophils (ANC) ≥ 1.5 × 10^9/L; platelet count (PLT) ≥ 90 × 10^9/L; 2) Blood biochemistry: Total bilirubin (TBIL) ≤ 1.5 upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 × ULN; alkaline phosphatase ≤ 2.5 × ULN; Urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 × ULN; 3) Heart color ultrasound: Left ventricular ejection fraction (LVEF) ≥ 55%;
  6. Women of childbearing age, tested negative for serum pregnancy test 7 days before randomization，and willing to use appropriate methods during the trial and within 8 weeks after the last administration of the test drug;
  7. A volunteer to participate in the study; provision of written informed consent; good compliance and willing to cooperate during the follow-up.

Exclusion Criteria:

  1. Known history of hypersensitivity to pyrotinib or any of it components;
  2. Patients have previously received antitumor treatment or radiation therapy for any malignant tumor (except for cervical carcinoma in situ and basal cell carcinoma that have been cured);
  3. Patients underwent major breast cancer-free surgery within 4 weeks and have not fully recovered;
  4. Subjects that are unable to swallow tablets,intestinal obstruction or dysfunction of gastrointestinal absorption;
  5. Patients with severe heart disease or discomfort who cannot be treated;
  6. The patient suffers from mental illness or psychotropic substance abuse and cannot cooperate;
  7. Pregnant or lactating women;
  8. Less than 4 weeks from the last clinical trial;
  9. Patients participating in other clinical trials at the same time
  10. The researchers think inappropriate.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Experimental group

    Control group

    Arm Description

    Patients will receive the test drug (Pyrotinib) combined with Epirubicin and Cyclophosphamide followed by Taxanes and Trastuzumab

    Patients will only receive Epirubicin and Cyclophosphamide followed by Taxanes and Trastuzumab

    Outcomes

    Primary Outcome Measures

    Pathological Complete Response rate(pCR)
    pathological complete response

    Secondary Outcome Measures

    Objective Response Rate(ORR)
    Baseline to measured stable disease
    Event Free Survival(EFS)
    Baseline to the occurrence of any event
    Disease-free survival(DFS) Baseline to measured date of recurrence or death from any cause
    Baseline to measured date of recurrence or death from any cause
    Overall survival (OS)
    Baseline to measured date of death from any cause

    Full Information

    First Posted
    February 27, 2020
    Last Updated
    February 27, 2020
    Sponsor
    Hebei Medical University Fourth Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04290793
    Brief Title
    Neoadjuvant Chemotherapy With Pyrotinib, Epirubicin and Cyclophosphamide Followed by Taxanes and Trastuzumab for HER-2+ Breast Cancer
    Official Title
    Neoadjuvant Chemotherapy With Pyrotinib, Epirubicin and Cyclophosphamide Followed by Taxanes and Trastuzumab for HER2+Breast Cancer: a Multicenter, Randomized, Open-label, Parallel-Group Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 1, 2020 (Anticipated)
    Primary Completion Date
    March 1, 2022 (Anticipated)
    Study Completion Date
    March 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hebei Medical University Fourth Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This is a prospective, open label, parallel controlled study to evaluate the efficacy and safety of neoadjuvant pyrotinib in HER2+ breast cancer patients

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    280 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental group
    Arm Type
    Experimental
    Arm Description
    Patients will receive the test drug (Pyrotinib) combined with Epirubicin and Cyclophosphamide followed by Taxanes and Trastuzumab
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    Patients will only receive Epirubicin and Cyclophosphamide followed by Taxanes and Trastuzumab
    Intervention Type
    Drug
    Intervention Name(s)
    Pyrotinib
    Intervention Description
    400mg administered as continuous oral once daily from the first day of the study
    Intervention Type
    Drug
    Intervention Name(s)
    Epirubicin
    Intervention Description
    90mg/m^2 d1 iv Q2W for 4 cycles
    Intervention Type
    Drug
    Intervention Name(s)
    Cyclophosphamide
    Intervention Description
    600 mg/m^2 d1 iv Q2W for 4 cycles
    Intervention Type
    Drug
    Intervention Name(s)
    Taxanes
    Intervention Description
    Albumin paclitaxel（125mg/m2 d1、8 iv Q3W for 4 Cycles）/Docetaxel(100mg/m2 d1 iv Q3W for 4 Cycles )
    Intervention Type
    Biological
    Intervention Name(s)
    Trastuzumab
    Intervention Description
    the first cycle is a loading dose of 8 mg / kg, followed by 6 mg / kg. Iv Q3W for 1 year
    Primary Outcome Measure Information:
    Title
    Pathological Complete Response rate(pCR)
    Description
    pathological complete response
    Time Frame
    within 3 weeks after surgery
    Secondary Outcome Measure Information:
    Title
    Objective Response Rate(ORR)
    Description
    Baseline to measured stable disease
    Time Frame
    2 years
    Title
    Event Free Survival(EFS)
    Description
    Baseline to the occurrence of any event
    Time Frame
    3 years
    Title
    Disease-free survival(DFS) Baseline to measured date of recurrence or death from any cause
    Description
    Baseline to measured date of recurrence or death from any cause
    Time Frame
    3 years
    Title
    Overall survival (OS)
    Description
    Baseline to measured date of death from any cause
    Time Frame
    5 years

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Female breast cancer patients at the age of >= 18 years and <= 65 years who received first treatment； Pathologically confirmed HER2-positive invasive breast cancer（which is defined as the immunohistochemistry score of > 10% immunoreactive cells being 3+ or in situ hybridization results showing HER2 gene amplification），regardless of hormone receptor status (ER and PR)； According to the 2019 CSCO BC guidelines: When HER-2 positive is used as the standard for preoperative neoadjuvant therapy for breast cancer, the tumor is larger than 2 cm； The Eastern Tumor Collaborative Group (ECOG) has a physical status score of ≤1； The functional level of the main organs must meet the following requirements ： 1) blood routine test: hemoglobin (Hb) ≥ 90g/L;Neutrophils (ANC) ≥ 1.5 × 10^9/L; platelet count (PLT) ≥ 90 × 10^9/L; 2) Blood biochemistry: Total bilirubin (TBIL) ≤ 1.5 upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 × ULN; alkaline phosphatase ≤ 2.5 × ULN; Urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 × ULN; 3) Heart color ultrasound: Left ventricular ejection fraction (LVEF) ≥ 55%; Women of childbearing age, tested negative for serum pregnancy test 7 days before randomization，and willing to use appropriate methods during the trial and within 8 weeks after the last administration of the test drug; A volunteer to participate in the study; provision of written informed consent; good compliance and willing to cooperate during the follow-up. Exclusion Criteria: Known history of hypersensitivity to pyrotinib or any of it components; Patients have previously received antitumor treatment or radiation therapy for any malignant tumor (except for cervical carcinoma in situ and basal cell carcinoma that have been cured); Patients underwent major breast cancer-free surgery within 4 weeks and have not fully recovered; Subjects that are unable to swallow tablets,intestinal obstruction or dysfunction of gastrointestinal absorption; Patients with severe heart disease or discomfort who cannot be treated; The patient suffers from mental illness or psychotropic substance abuse and cannot cooperate; Pregnant or lactating women; Less than 4 weeks from the last clinical trial; Patients participating in other clinical trials at the same time The researchers think inappropriate.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    YUNJIANG LIU, PHD.
    Phone
    86095588
    Email
    lyj818326@126.com

    12. IPD Sharing Statement

    Learn more about this trial

    Neoadjuvant Chemotherapy With Pyrotinib, Epirubicin and Cyclophosphamide Followed by Taxanes and Trastuzumab for HER-2+ Breast Cancer

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