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

Sponsor
Fujian Medical University Union Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05255523
Collaborator
(none)
60
1
34

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the effect of pyrotinib

Condition or Disease Intervention/Treatment Phase
Phase 2

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Anticipated Study Start Date :
Feb 20, 2022
Anticipated Primary Completion Date :
Nov 5, 2023
Anticipated Study Completion Date :
Dec 20, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1

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.

Drug: pyrotinib
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
Other Names:
  • capecitabine
  • Outcome Measures

    Primary Outcome Measures

    1. Incidence of first progression with brain metastases [24 month]

      Incidence of first progression with brain metastases

    Secondary Outcome Measures

    1. ORR without CNS [24 month]

      Baseline to measured stable disease without central nervous system

    2. TTBM [24 month]

      Time to brain metastases

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Fujian Medical University Union Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fujian Medical University Union Hospital
    ClinicalTrials.gov Identifier:
    NCT05255523
    Other Study ID Numbers:
    • 001
    First Posted:
    Feb 24, 2022
    Last Update Posted:
    Feb 24, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Fujian Medical University Union Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 24, 2022