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Neoadjuvant Study of Pyrotinib and Trastuzumab Plus Chemotherapy in Patients With HER2 Positive Breast Cancer

Primary Purpose

HER2-positive Breast Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pyrotinib+Trastuzumab+Docetaxel+Carboplatin
Sponsored by
Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HER2-positive Breast Cancer

Eligibility Criteria

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

Inclusion Criteria:

  1. female patients, 18 years ≤ age ≤75 years；
  2. Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1;
  3. Histologically confirmed invasive breast cancer（early stage or locally advanced）
  4. HER2 positive (HER2+++ by IHC or FISH+)
  5. Known hormone receptor status.
  6. Cardiovascular: Baseline left ventricular ejection fraction (LVEF)≥55% measured by ECHO
  7. Signed informed consent form (ICF)

Exclusion Criteria:

  1. Metastatic disease (Stage IV) or inflammatory breast cancer.
  2. Previous or current history of malignant neoplasms, except for curatively treated: Basal and squamous cell carcinoma of the skin, Carcinoma in situ of the cervix.
  3. Clinically relevant cardiovascular disease: Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);
  4. Unable or unwilling to swallow tablets.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Pyrotinib+Trastuzumab+Docetaxel+Carboplatin

    Arm Description

    Outcomes

    Primary Outcome Measures

    Percentage of Participants With Pathological Complete Response (pCR)

    Secondary Outcome Measures

    Event-free survival
    Disease-free Survival
    Distance Disease-free Survival
    Objective Response Rate

    Full Information

    First Posted
    February 19, 2019
    Last Updated
    February 28, 2019
    Sponsor
    Shandong University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03847818
    Brief Title
    Neoadjuvant Study of Pyrotinib and Trastuzumab Plus Chemotherapy in Patients With HER2 Positive Breast Cancer
    Official Title
    A Prospective, Open-label,Multicenter Phase II Study of Neoadjuvant Pyrotinib Plus Trastuzumab and Chemotherapy in Women With HER2 Positive Early Stage or Locally Advanced Breast Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 1, 2019 (Anticipated)
    Primary Completion Date
    March 1, 2020 (Anticipated)
    Study Completion Date
    February 28, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shandong University

    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,multicenter Phase II study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus chemotherapy as neoadjuvant treatment in HER2 positive early stage or locally advanced breast cancer.
    Detailed Description
    The investigators hypothesized that the experimental group (Pyrotinib+Trastuzumab+Docetaxel+ Carboplatin) could have a higher Pathological Complete Response (pCR) rate than the control group (Trastuzumab+Docetaxel+ Carboplatin) in neoadjuvant chemotherapy. It is proposed that 268 participants will be enrolled in this study. The target population is women with early breast cancer (stage of T2-3N0-3M0) who are eligible for primary systemic therapy. The primary objective of the trial is to determine the pCR rate. The secondary objective of the trial is to determine the Event-free survival(EFS), Disease-free Survival (DFS), Distance Disease-free Survival (DDFS), Objective Response Rate (ORR) rate.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HER2-positive Breast Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Pyrotinib (400mg orally daily)+Trastuzumab (8mg/kg iv load followed by 6mg/kg iv 3-weekly)+Docetaxel (75mg/m2)+ Carboplatin(AUC=5/6), for a total of 4 cycles.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    268 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Pyrotinib+Trastuzumab+Docetaxel+Carboplatin
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Pyrotinib+Trastuzumab+Docetaxel+Carboplatin
    Intervention Description
    Drug: Pyrotinib Pyrotinib: 400mg orally daily Drug: Trastuzumab Trastuzumab:8mg/kg iv load followed by 6mg/kg iv 3-weekly for a total of 6 cycles; Drug: Docetaxel Docetaxel: 75mg/m2 for a total of 6 cycles Drug: Carboplatin Carboplatin: AUC=5 or 6 for a total of 6 cycles
    Primary Outcome Measure Information:
    Title
    Percentage of Participants With Pathological Complete Response (pCR)
    Time Frame
    through study completion, an average of 1 year
    Secondary Outcome Measure Information:
    Title
    Event-free survival
    Time Frame
    Following surgery until Year 3
    Title
    Disease-free Survival
    Time Frame
    Following surgery until Year 3
    Title
    Distance Disease-free Survival
    Time Frame
    Following surgery until Year 3
    Title
    Objective Response Rate
    Time Frame
    Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery) up to approximately 12 months

    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, 18 years ≤ age ≤75 years； Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1; Histologically confirmed invasive breast cancer（early stage or locally advanced） HER2 positive (HER2+++ by IHC or FISH+) Known hormone receptor status. Cardiovascular: Baseline left ventricular ejection fraction (LVEF)≥55% measured by ECHO Signed informed consent form (ICF) Exclusion Criteria: Metastatic disease (Stage IV) or inflammatory breast cancer. Previous or current history of malignant neoplasms, except for curatively treated: Basal and squamous cell carcinoma of the skin, Carcinoma in situ of the cervix. Clinically relevant cardiovascular disease: Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110); Unable or unwilling to swallow tablets.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yu Zhigang, DR.
    Phone
    +86 13864182636
    Email
    yzg@medmail.com.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yu Zhigang, DR.
    Organizational Affiliation
    The Second Hospital of Shandong University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Neoadjuvant Study of Pyrotinib and Trastuzumab Plus Chemotherapy in Patients With HER2 Positive Breast Cancer

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