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Neoadjuvant Study of Navelbine in Patients With HER2 Positive Breast Cancer

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Navelbine
Docetaxel
Sponsored by
Zhejiang Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Female patients, 18 years ≤ age ≤ 80 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    NHP

    THP

    Arm Description

    Navelbine, Herceptin, Pertuzumab

    Docetaxel, Herceptin, Pertuzumab

    Outcomes

    Primary Outcome Measures

    pCR
    Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery.

    Secondary Outcome Measures

    DFS
    Disease-free Survival
    DDFS
    Distance Disease-free Survival
    ORR
    Objective Response Rate

    Full Information

    First Posted
    December 7, 2020
    Last Updated
    December 7, 2020
    Sponsor
    Zhejiang Cancer Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04665986
    Brief Title
    Neoadjuvant Study of Navelbine in Patients With HER2 Positive Breast Cancer
    Official Title
    A Study to Evaluate Navelbine in Combination With Trastuzumab Plus Pertuzumab in Patients With HER2 Positive Early Stage or Locally Advanced Breast Cancer in Neoadjuvant Treatment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 1, 2021 (Anticipated)
    Primary Completion Date
    February 28, 2022 (Anticipated)
    Study Completion Date
    February 28, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Zhejiang Cancer 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 randomized, double-blind multicenter Phase III study for evaluating the efficacy of neoadjuvant Navelbine plus trastuzumab and Pertuzumab versus Docetaxel plus trastuzumab and Pertuzumab given as neoadjuvant treatment in HER2 positive early-stage or locally advanced breast cancer.

    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 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    NHP
    Arm Type
    Experimental
    Arm Description
    Navelbine, Herceptin, Pertuzumab
    Arm Title
    THP
    Arm Type
    Active Comparator
    Arm Description
    Docetaxel, Herceptin, Pertuzumab
    Intervention Type
    Drug
    Intervention Name(s)
    Navelbine
    Intervention Description
    Navelbine 25mg/m2 on day 1 and 8, every 3 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Docetaxel
    Intervention Description
    Docetaxel 90mg/m2 on day 1, every 3 weeks
    Primary Outcome Measure Information:
    Title
    pCR
    Description
    Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery.
    Time Frame
    Through study completion, an average of 1 year
    Secondary Outcome Measure Information:
    Title
    DFS
    Description
    Disease-free Survival
    Time Frame
    Following surgery until Year 3
    Title
    DDFS
    Description
    Distance Disease-free Survival
    Time Frame
    Following surgery until Year 3
    Title
    ORR
    Description
    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
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Female patients, 18 years ≤ age ≤ 80 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.

    12. IPD Sharing Statement

    Learn more about this trial

    Neoadjuvant Study of Navelbine in Patients With HER2 Positive Breast Cancer

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