MedTrace Logo

Pyrotinib in Women With High-risk in Early Stage Breast Cancer

NCT05834764 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2023-04-28

No results posted yet for this study

Summary

ExteNET study explored neratinib prolong anti-HER2 therapy after trastuzumab therapy found that it can improve disease-free survival in patients with lymph nodes positive; In addition, the subgroup of patients with residual tumors after neoadjuvant therapy was found to improve the survival. However, no conclusive conclusions were reached.

However, since the study was carried out early so only trastuzumab treatment was used, it is urgent to carry out research that is more in line with current clinical practice and bring more benefits to patients. To explore whether pyrotinib can further reduce the risk of recurrence from previously diagnosed HER2-positive breast cancer after treatment with trastuzumab and pertuzumab or T-DM1.

Conditions

Interventions

DRUG

Pyrotinib

Pyrotinib after anti-HER2 therapy（Trastuzumab combined with Pertuzumab or T-DM1）

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    collaborator INDUSTRY

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Principal Investigators

  • Xiaoan Liu, Professor · Jiangsu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University

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
2023-04-08
Primary Completion
2026-06-01
Completion
2028-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT05834764 on ClinicalTrials.gov