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

NCT06470347 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2024-06-24

No results posted yet for this study

Summary

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.

Conditions

  • HER-2 Positive Advanced Breast Cancer

Interventions

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.

Sponsors & Collaborators

  • Zunyi Medical College

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2024-11-01
Completion
2025-11-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06470347 on ClinicalTrials.gov