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Continuous or Intermittent Pyrotinib for HER2-positive Advanced Breast Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Continuous or Intermittent Pyrotinib for HER2-positive Advanced Breast Cancer

Continuous or Intermittent Pyrotinib for HER2-positive Advanced Breast Cancer: a Prospective, Randomized, Controlled, Multicentre Clinical Trial

NCT07180082•Wenjin Yin

View on ClinicalTrials.gov

Summary

This is a prospective, randomised, controlled, multicentre study to evaluate the efficacy and safety of continuous versus intermittent pyrotinib therapy in patients with human epidermal growth factor receptor (HER2)-positive advanced breast cancer.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age≥18 years old
•Pathologically confirmed advanced or locally advanced breast cancer not amenable to curative surgery
•Pathologically confirmed HER2+ at least once for either primary or metastatic lesion
•Previously treated with any number of lines for advanced disease and eligible for a pyrotinib-containing regimen at the discretion of physician
•At least one measurable lesion or bone-only disease (osteolytic or mixed) according to RECIST v1.1
•ECOG 0-1
•Adequate organ function

Exclusion Criteria

•During pregnancy and lactation
•Difficulties with pyrotinib administration or absorption

Locations (1)

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, China

Key Dates

Start Date

August 28, 2025

Primary Completion Date

September 1, 2028

Completion Date

September 1, 2029

Last Updated

November 18, 2025

Enrollment

186

ESTIMATED participants

Conditions

Advanced Breast Cancer

Interventions

Pyrotinib

DRUG

Contacts

Wenjin Yin, M.D.

CONTACT

86(21)68385569 yinwenjin@renji.com

Yin

CONTACT

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Continuous or Intermittent Pyrotinib for HER2-positive Advanced Breast Cancer

Inclusion Criteria

Exclusion Criteria

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