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Pyrotinib Plus Trastuzumab After First-line TH (P) Treatment With HER-2 Positive Breast Cancer

Primary Purpose

Advanced Breast Cancer

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
pyrotinib
Sponsored by
Fujian Medical University Union Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Advanced Breast Cancer focused on measuring pyrotinib;CNS;breast cancer; HER-2 positivity

Eligibility Criteria

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

Inclusion Criteria:

  1. age:18-75 years old, female;
  2. HER2 positive advanced breast cancer diagnosed by pathology, cytology or radiology, including inoperable breast cancer with stage IV, or recurrent/metastatic breast cancer.HER-2 positivity was confirmed by histopathological test: immunohistochemistry(IHC) results of 3 + or in situ hybridization (ISH) results of amplification of HER2;
  3. Disease progression occurs after treatment with trastuzumab (stopping the drug for more than 12 months) or newly diagnosed IV stage breast cancer patients;
  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
  5. Life expectancy greater than or equal to 6 months;
  6. The main organs function well, and the inspection indicators meet the following requirements:

1) For results of blood routine test HB≥90g/L; ANC≥1.5×109/L; PLT≥90×109/L; 2) For results of blood biochemical test ALT and AST≤2×ULN, but≤5×ULN if the transferanse elevation is due to liver metastases； TBIL≤1.5×ULN； Serum creatinine ≤1.5×ULN; 7. The researchers believed that the subjects were preference to benefit; 8. Participants were willing to join in this study, and written informed consent.

Exclusion Criteria:

  1. Patients with brain metastases by CT or MRI;
  2. More factors affecting of oral drugs (gastrointestinal surgery history, inability to swallow, chronic diarrhea, intestinal obstruction);
  3. Study drug and excipient allergy;
  4. History of psychiatric drugs abuse and can't quit or patients with mental disorders;
  5. Pregnant or lactating female patients;
  6. Less than 4 weeks from the last clinical trial;
  7. The researchers think inappropriate.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Arm 1

    Arm Description

    Pyrotinib：400mg qd po continuous medication Capecitabine: 1000 mg/m2 bid po for 14 consecutive days with 7 days off, every 21 days as a cycle.

    Outcomes

    Primary Outcome Measures

    Incidence of first progression with brain metastases
    Incidence of first progression with brain metastases

    Secondary Outcome Measures

    ORR without CNS
    Baseline to measured stable disease without central nervous system
    TTBM
    Time to brain metastases

    Full Information

    First Posted
    February 16, 2022
    Last Updated
    February 16, 2022
    Sponsor
    Fujian Medical University Union Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05255523
    Brief Title
    Pyrotinib Plus Trastuzumab After First-line TH (P) Treatment With HER-2 Positive Breast Cancer
    Official Title
    A Single Arm，Multicenter，Real-world Observational Study of Pyrotinib Plus Trastuzumab After First-line TH (P) Treatment With HER-2 Positive Breast Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 20, 2022 (Anticipated)
    Primary Completion Date
    November 5, 2023 (Anticipated)
    Study Completion Date
    December 20, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fujian Medical University Union 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
    The purpose of this study is to assess the effect of pyrotinib
    Detailed Description
    The purpose of this study is to assess the effect of pyrotinib combined with trastuzumab in the maintenance phase delay/reduction of brain metastases after first-line TH(P) therapy for HER-2-positive advanced breast cancer

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Advanced Breast Cancer
    Keywords
    pyrotinib;CNS;breast cancer; HER-2 positivity

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm 1
    Arm Type
    Experimental
    Arm Description
    Pyrotinib：400mg qd po continuous medication Capecitabine: 1000 mg/m2 bid po for 14 consecutive days with 7 days off, every 21 days as a cycle.
    Intervention Type
    Drug
    Intervention Name(s)
    pyrotinib
    Other Intervention Name(s)
    capecitabine
    Intervention Description
    After 4-6 cycles of taxane chemotherapeutics combined with trastuzumab±pertuzumab, the assessment result reaches CR or PR, and the subsequent sequential pyrrotinib plus capecitabine±trastuzumab to CNS Progress
    Primary Outcome Measure Information:
    Title
    Incidence of first progression with brain metastases
    Description
    Incidence of first progression with brain metastases
    Time Frame
    24 month
    Secondary Outcome Measure Information:
    Title
    ORR without CNS
    Description
    Baseline to measured stable disease without central nervous system
    Time Frame
    24 month
    Title
    TTBM
    Description
    Time to brain metastases
    Time Frame
    24 month

    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: age:18-75 years old, female; HER2 positive advanced breast cancer diagnosed by pathology, cytology or radiology, including inoperable breast cancer with stage IV, or recurrent/metastatic breast cancer.HER-2 positivity was confirmed by histopathological test: immunohistochemistry(IHC) results of 3 + or in situ hybridization (ISH) results of amplification of HER2; Disease progression occurs after treatment with trastuzumab (stopping the drug for more than 12 months) or newly diagnosed IV stage breast cancer patients; Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; Life expectancy greater than or equal to 6 months; The main organs function well, and the inspection indicators meet the following requirements: 1) For results of blood routine test HB≥90g/L; ANC≥1.5×109/L; PLT≥90×109/L; 2) For results of blood biochemical test ALT and AST≤2×ULN, but≤5×ULN if the transferanse elevation is due to liver metastases； TBIL≤1.5×ULN； Serum creatinine ≤1.5×ULN; 7. The researchers believed that the subjects were preference to benefit; 8. Participants were willing to join in this study, and written informed consent. Exclusion Criteria: Patients with brain metastases by CT or MRI; More factors affecting of oral drugs (gastrointestinal surgery history, inability to swallow, chronic diarrhea, intestinal obstruction); Study drug and excipient allergy; History of psychiatric drugs abuse and can't quit or patients with mental disorders; Pregnant or lactating female patients; Less than 4 weeks from the last clinical trial; The researchers think inappropriate.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Pyrotinib Plus Trastuzumab After First-line TH (P) Treatment With HER-2 Positive Breast Cancer

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