search
Back to results

Pyrotinib Combined With Trastuzumab and Chemotherapy Neoadjuvant Therapy for HER2-positive Breast Cancer

Primary Purpose

Breast Cancer Female

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pyrotinib and Trastuzumab
Sponsored by
Youzhi Zhu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer Female

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Female patients aged 18-75 years; Her2-positive breast cancer confirmed by pathology; invasive breast cancer confirmed by histology, Tumor stage: early stage (T1c-3, N0-1, M0) or locally advanced stage (T2-4, N2, N3, M0); ECOG PS: 0-1 score; Plan to undergo the final surgical removal of breast cancer, i.e. breast conserving surgery or total mastectomy, sentinel lymph node (SN) biopsy or axillary lymph node dissection (ALND) Normal function of major organs means that the following criteria are met: (1) Blood test neutrophil (ANC) >=1.5x10^9/L; Platelet count (PLT) >=90x10^9/L; Hemoglobin (Hb) >=90g/L; (2) Total bilirubin (TBIL) <=1.5 upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=1.5xULN; Alkaline phosphatase <=2.5xULN; Urea nitrogen (BUN) and creatinine (Cr) <=1.5xULN; (3) Left ventricular ejection fraction (LVEF) >=55%; (4) The QT interval (QTcF) corrected by Fridericia method was less than 470msec in 12-lead ECG; 7. For women who have not undergone menopause or surgical sterilization: consent to abstinence or use an effective contraceptive method (during treatment and for at least 7 months after the last dose in the study treatment); 8. Volunteer to participate in this study, sign the informed consent, have good compliance and be willing to cooperate with follow-up. Exclusion Criteria: Known allergic history of the drug components of this protocol; Previous or co-existing other malignant tumors, except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix; Participated in clinical trials of other antitumor drugs within four weeks; Stage IV (metastatic) breast cancer; Multiple factors affecting oral medication (e.g., inability to swallow, post-gastrointestinal resection, chronic diarrhea, and intestinal obstruction); A history of congestive heart failure (CHF) or uncontrolled heart disease (angina, arrhythmia, hypertension); Patients with active infection and severe mental illness; Pregnant or lactating patients; Patients with allergies or known history of allergies to the drug components of this protocol; A history of immunodeficiency, including being HIV positive, or having other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; Concomitant diseases that, in the judgment of the investigator, seriously endanger the patient's safety or interfere with the patient's completion of the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Pyrotinib Combined With Trastuzumab and Chemotherapy

    Arm Description

    T1cN0M0 HER2+ breast cancer Patients received 2 cycles (pyrotinib + trastuzumab + taxoid) regimen and were evaluated to continue with the original regimen if PR, and 4 cycles (pyrotinib + trastuzumab + taxoid + carboplatin) regimen if SD/PD. Phase II-III HER2+ breast cancer Patients received 6 cycles of treatment (pyrotinib + trastuzumab + taxoid + carboplatin)

    Outcomes

    Primary Outcome Measures

    tpCR
    total Pathological Complete Response

    Secondary Outcome Measures

    Full Information

    First Posted
    August 31, 2023
    Last Updated
    September 11, 2023
    Sponsor
    Youzhi Zhu
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT06035679
    Brief Title
    Pyrotinib Combined With Trastuzumab and Chemotherapy Neoadjuvant Therapy for HER2-positive Breast Cancer
    Official Title
    Prospective, Single-center, Observational Clinical Study of Pyrotinib Combined With Trastuzumab and Chemotherapy Neoadjuvant Therapy for HER2-positive Breast Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 20, 2023 (Anticipated)
    Primary Completion Date
    November 30, 2026 (Anticipated)
    Study Completion Date
    November 30, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Youzhi Zhu

    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 study is a prospective, single-center, observational clinical study, The objection was to observe the treatment of pyrotinib combined with trastuzumab and neoadjuvant chemotherapy Efficacy of Stage II-III breast cancer and observation of the efficacy of step-down neoadjuvant therapy for HER2-positive stage T1cN0M0 breast cancer.
    Detailed Description
    This study is a prospective, single-center, observational clinical study,Which plan to be enroll 30 patients with HER2-positive early breast cancer receive pyrotinib combined with trastuzumab and chemotherapy neoadjuvant therapy. The primary endpoint was the total pathological complete response rate (tpCR) , The objection was to observe the treatment of pyrotinib combined with trastuzumab and neoadjuvant chemotherapy Efficacy of Stage II-III breast cancer and observation of the efficacy of step-down neoadjuvant therapy for HER2-positive stage T1cN0M0 breast cancer.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Pyrotinib Combined With Trastuzumab and Chemotherapy
    Arm Type
    Experimental
    Arm Description
    T1cN0M0 HER2+ breast cancer Patients received 2 cycles (pyrotinib + trastuzumab + taxoid) regimen and were evaluated to continue with the original regimen if PR, and 4 cycles (pyrotinib + trastuzumab + taxoid + carboplatin) regimen if SD/PD. Phase II-III HER2+ breast cancer Patients received 6 cycles of treatment (pyrotinib + trastuzumab + taxoid + carboplatin)
    Intervention Type
    Drug
    Intervention Name(s)
    Pyrotinib and Trastuzumab
    Other Intervention Name(s)
    dual HER2 blockade in the neoadjuvant setting
    Intervention Description
    Small and large molecules combined with chemotherapy for neoadjuvant treatment of HER2-positive breast cancer
    Primary Outcome Measure Information:
    Title
    tpCR
    Description
    total Pathological Complete Response
    Time Frame
    at surgery

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Female patients aged 18-75 years; Her2-positive breast cancer confirmed by pathology; invasive breast cancer confirmed by histology, Tumor stage: early stage (T1c-3, N0-1, M0) or locally advanced stage (T2-4, N2, N3, M0); ECOG PS: 0-1 score; Plan to undergo the final surgical removal of breast cancer, i.e. breast conserving surgery or total mastectomy, sentinel lymph node (SN) biopsy or axillary lymph node dissection (ALND) Normal function of major organs means that the following criteria are met: (1) Blood test neutrophil (ANC) >=1.5x10^9/L; Platelet count (PLT) >=90x10^9/L; Hemoglobin (Hb) >=90g/L; (2) Total bilirubin (TBIL) <=1.5 upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=1.5xULN; Alkaline phosphatase <=2.5xULN; Urea nitrogen (BUN) and creatinine (Cr) <=1.5xULN; (3) Left ventricular ejection fraction (LVEF) >=55%; (4) The QT interval (QTcF) corrected by Fridericia method was less than 470msec in 12-lead ECG; 7. For women who have not undergone menopause or surgical sterilization: consent to abstinence or use an effective contraceptive method (during treatment and for at least 7 months after the last dose in the study treatment); 8. Volunteer to participate in this study, sign the informed consent, have good compliance and be willing to cooperate with follow-up. Exclusion Criteria: Known allergic history of the drug components of this protocol; Previous or co-existing other malignant tumors, except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix; Participated in clinical trials of other antitumor drugs within four weeks; Stage IV (metastatic) breast cancer; Multiple factors affecting oral medication (e.g., inability to swallow, post-gastrointestinal resection, chronic diarrhea, and intestinal obstruction); A history of congestive heart failure (CHF) or uncontrolled heart disease (angina, arrhythmia, hypertension); Patients with active infection and severe mental illness; Pregnant or lactating patients; Patients with allergies or known history of allergies to the drug components of this protocol; A history of immunodeficiency, including being HIV positive, or having other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; Concomitant diseases that, in the judgment of the investigator, seriously endanger the patient's safety or interfere with the patient's completion of the study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    zhu youzhi
    Phone
    17759120588
    Email
    zhu@fjmu.edu.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    zhu youzhi
    Organizational Affiliation
    First Affiliated Hospital of Fujian Medical University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    There is not a plan to make IPD available

    Learn more about this trial

    Pyrotinib Combined With Trastuzumab and Chemotherapy Neoadjuvant Therapy for HER2-positive Breast Cancer

    We'll reach out to this number within 24 hrs