A Real-World Study of Pyrrolitinib Maleate Tablets for HER-2-Positive Early or Locally Advanced Breast Cancer After Adjuvant Trastuzumab Therapy

June 21, 2024 updated by: LV Junyuan, Doctor of Medicine, Zunyi Medical College

Purpose of the Study:

Primary Study Objective:

To evaluate the efficacy of pyrrolitinib maleate tablets in the treatment of HER-2-positive early or locally advanced breast cancer after adjuvant therapy with trastuzumab

Secondary Research Objectives:

To evaluate the safety of pyrrolitinib maleate tablets in the treatment of HER-2 positive early or locally advanced breast cancer after trastuzumab adjuvant therapy

Study Endpoints Primary Study Endpoint:

Invasive disease free survival (iDFS)

Secondary Study Endpoints:

  1. overall survival (OS);
  2. disease-free survival (DFS);
  3. distant metastasis free survival (DDFS);
  4. safety Study Population: Patients with early or locally advanced HER-2 positive breast cancer with clinical stage 0-III who have received prior neoadjuvant or adjuvant therapy. where the neoadjuvant and/or adjuvant treatment phase has been completed at least ≥24 weeks (8 dosing cycles) of trastuzumab therapy and the time interval between the end of the last course of trastuzumab therapy and entry into the study must be ≤1 year Study Design: Single-arm, multicenter, interventional study Administration Pyrrolitinib: The recommended dose of this product is 400 mg orally once daily within 30 minutes after breakfast for 52 weeks (approximately one year).

Dose adjustments may be made in accordance with this protocol, taking into account adverse reactions in subjects. Each consecutive suspension of piretinib during the course of the study should not exceed 14 days, prophylactic use of medications for the treatment of diarrhea is permitted during the course of treatment, multiple suspensions of study medication due to adverse events are permitted, and doses of piretinib that are missed for any reason will not be made up.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

67

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guizhou
      • Zunyi, Guizhou, China
        • Recruiting
        • Affiliated Hospital of Zunyi Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age: 18-75 years;
  • Invasive breast cancer with clinical stage 0-III and treated surgically;
  • Histopathologically confirmed HER-2 positivity: immunohistochemistry (IHC) result of 3+ or in situ hybridization (ISH) result of HER-2 gene amplification (HER-2/CEP17 ≥ 2.0 or average HER-2 copy number/cell ≥ 6);

  • Have undergone radical mastectomy or breast-conserving surgery for breast cancer, with no cancer left in the body and no recurrence of metastatic disease after surgery:

    1. Pathologic test confirms that there is no residual invasive cancer at the margins and no residual ductal carcinoma in situ;
    2. Patients who have not received neoadjuvant therapy should have negative surgical margins, and there is no requirement for the presence of lymph node metastasis (including the presence of lymph node micrometastasis) suggested by postoperative pathological tests;
    3. Patients receiving neoadjuvant therapy are not allowed to have postoperative pathologic evidence of invasive carcinoma in the breast or axillary lymph nodes;
  • Previous trastuzumab anti-HER-2 therapy: completion of ≥24 weeks (8 dosing cycles) of trastuzumab in the neoadjuvant and/or adjuvant phases; the interval between the end of the last course of trastuzumab therapy and entry into the study must be ≤1 year.
  • Known hormone receptor status (ER/PR);
  • ECOG score of 0-1;

Normal function of major organs:

  1. Blood count:

    Neutrophils (ANC) ≥ 1.5 x 109/L; Platelet count (PLT) ≥90×109/L; Hemoglobin (Hb) ≥90 g/L;

  2. Blood biochemistry:

    Total bilirubin (TBIL) ≤1.5 × upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5 × ULN; Alkaline phosphatase ≤ 2.5 x ULN; Urea or urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 × ULN;

  3. Cardiac ultrasound:

    Left ventricular ejection fraction (LVEF) ≥55%;

  4. 12-lead electrocardiogram: Fridericia-corrected QT interval (QTcF) < 470 msec.

    • For female patients who are not menopausal or surgically sterilized: consent to abstinence or use of an effective non-hormonal pharmacologic method of contraception for the duration of treatment and for 8 weeks after the last dose of study treatment;
    • Benefit in the opinion of the investigator;
    • Voluntarily participate in the study by signing an informed consent form.

Exclusion Criteria:

  • Confirmed local/regional recurrence/metastasis at enrollment;
  • Prior anti-HER-2 therapy with pyrrolitinib, lenatinib, lapatinib and other tyrosine kinase inhibitors;
  • History of gastrointestinal disease with diarrhea as the primary symptom;
  • Psychiatric illness or psychotropic substance abuse that prevents cooperation;
  • Female patients who are pregnant or breastfeeding;
  • Those who, in the opinion of the investigator, are not suitable for enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pyrrolitinib
Subjects will receive 52 weeks (approximately 1 year) of continuous oral administration of piretinib, 400 mg administered once daily, within 30 minutes of breakfast.
Drug: A Real-World Study of Pyrrolitinib Maleate Tablets for HER-2-Positive Early or Locally Advanced Breast Cancer After Adjuvant Trastuzumab Therapy
During treatment, subjects were given 400 mg pyrrotinib once daily, within 30 minutes after breakfast.
Other Names:
  • pyrrolitinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
invasive disease-free survival
Time Frame: 18 months Max
18 months Max

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zunyi Medical College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

March 24, 2024

First Submitted That Met QC Criteria

June 21, 2024

First Posted (Actual)

June 24, 2024

Study Record Updates

Last Update Posted (Actual)

June 24, 2024

Last Update Submitted That Met QC Criteria

June 21, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZMU-BRCA-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HER-2 Positive Advanced Breast Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe