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Capecitabine Plus Pyrotinib Versus Capecitabine Plus Trastuzumab and Pertuzumab in the First-line Treatment of HER2-positive Metastatic Breast Cancer

Primary Purpose

Metastatic Breast Cancer

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Capecitabine and Pyrotinib
Capecitabine,Trastuzumab, and Pertuzumab
Sponsored by
Shandong Cancer Hospital and Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Breast Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • HER2 positive recurrent or metastasis breast cancer.
  • Patients with measurable disease are eligible.
  • Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1.
  • Adequate organ function.
  • Signed, written inform consent obtained prior to any study procedure.

Exclusion Criteria:

  • History of anti-cancer therapy for MBC(with the exception of one prior hormonal regimen for MBC).
  • History of HER tyrosine kinase inhibitors or monoclonal antibody for breast cancer in any treatment setting,except trastuzumab used in the neo-adjuvant or adjuvant setting.
  • Assessed by the investigator to be unable receive systemic chemotherapy.
  • History of other malignancy within the last 5 years,except for carcinoma in situ of cervix,basal cell carcinoma or squamous cell carcinoma of the skin that has been previously treated with curative intent.
  • Pregnant or lactating women,or for women of childbearing potential unwilling to use a highly-effective contraception during of the study treatment and for at least 7 months after the last dose of study treatment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    A

    B

    Arm Description

    Outcomes

    Primary Outcome Measures

    Progression Free Survival

    Secondary Outcome Measures

    Adverse Events and Serious Adverse Events
    AEs+SAEs
    Overall Survival
    Objective Response Rate
    Duration of Objective Response
    Clinical Benefit rate

    Full Information

    First Posted
    January 28, 2020
    Last Updated
    January 30, 2020
    Sponsor
    Shandong Cancer Hospital and Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04246502
    Brief Title
    Capecitabine Plus Pyrotinib Versus Capecitabine Plus Trastuzumab and Pertuzumab in the First-line Treatment of HER2-positive Metastatic Breast Cancer
    Official Title
    A Phase 2,Randomized, Evaluate Efficacy and Safety of Capecitabine Plus Pyrotinib Versus Capecitabine Plus Trastuzumab and Pertuzumab in the First-line Treatment of HER2-positive Metastatic Breast Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2020 (Anticipated)
    Primary Completion Date
    December 2022 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shandong Cancer Hospital and Institute

    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, multicenter phase 2 clinical trial to evaluate the efficacy and safety of capecitabine plus pyrotinib versus capecitabine plus trastuzumab plus pertuzumab in patients who have HER2 positive metastatic breast cancer and have not received systemic anticancer therapy for advanced disease.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    A
    Arm Type
    Experimental
    Arm Title
    B
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Capecitabine and Pyrotinib
    Intervention Description
    Pyrotinib 400mg orally daily until progressive disease
    Intervention Type
    Drug
    Intervention Name(s)
    Capecitabine,Trastuzumab, and Pertuzumab
    Intervention Description
    as instruction
    Primary Outcome Measure Information:
    Title
    Progression Free Survival
    Time Frame
    Approximately 42 months
    Secondary Outcome Measure Information:
    Title
    Adverse Events and Serious Adverse Events
    Description
    AEs+SAEs
    Time Frame
    From the first drug administration to within 28 days for the last treatment
    Title
    Overall Survival
    Time Frame
    Up to 2 years
    Title
    Objective Response Rate
    Time Frame
    Approximately 42 months
    Title
    Duration of Objective Response
    Time Frame
    Approximately 42 months
    Title
    Clinical Benefit rate
    Time Frame
    From the start of randomization to 6 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: HER2 positive recurrent or metastasis breast cancer. Patients with measurable disease are eligible. Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1. Adequate organ function. Signed, written inform consent obtained prior to any study procedure. Exclusion Criteria: History of anti-cancer therapy for MBC(with the exception of one prior hormonal regimen for MBC). History of HER tyrosine kinase inhibitors or monoclonal antibody for breast cancer in any treatment setting,except trastuzumab used in the neo-adjuvant or adjuvant setting. Assessed by the investigator to be unable receive systemic chemotherapy. History of other malignancy within the last 5 years,except for carcinoma in situ of cervix,basal cell carcinoma or squamous cell carcinoma of the skin that has been previously treated with curative intent. Pregnant or lactating women,or for women of childbearing potential unwilling to use a highly-effective contraception during of the study treatment and for at least 7 months after the last dose of study treatment.

    12. IPD Sharing Statement

    Learn more about this trial

    Capecitabine Plus Pyrotinib Versus Capecitabine Plus Trastuzumab and Pertuzumab in the First-line Treatment of HER2-positive Metastatic Breast Cancer

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