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Clinical Trials in China / NCT07180082
Recruiting Phase 2

Continuous or Intermittent Pyrotinib for HER2-positive Advanced Breast Cancer

NCT07180082 · tracked via the Priya Life Science China tracker
Sponsor
Wenjin Yin
Phase
Phase 2
Started
2025-08-28
Last updated
2025-11-18

Condition(s) studied

Advanced Breast Cancer

Investigational drug(s) / intervention(s)

Pyrotinib →

Pyrotinib: anti-HER2 tyrosine kinase inhibitor

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Overall response rate (ORR) — From the date of starting pyrotinib to the date of confirmed CR or PR (up to approximately 1 years)
    ORR is the percentage of subjects with complete remission (CR) or partial remission (PR) as the best response during the period from the beginning of the treatment to the progression of the disease or the completion of therapy (CR+PR)/Analysis of the total number of people. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) was used to assess the objective tumor response.

Trial sites (1)

FacilityCityRegionStatus
Renji Hospital, School of Medicine, Shanghai Jiaotong University Shanghai China Recruiting

More Wenjin Yin trials in China

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Iparomlimab and Tuvonralimab (QL1706) in Patients With HR-positive, HER2-negative Advanced Breast Cancer Recruiting
The Association Between Blood Routine Parameters and Breast Cancer Prognosis Active, not recruiting

Other trials for the same condition

Combination Followed by Maintenance Chemotherapy Versus CDK4/6 Inhibitor Combined With Endocrine Therapy for HR Low/HER2-negative Advanced Breast Cancer: a Prospective, Randomized, Open-label Phase Ⅱ Clinical Trial Recruiting
The Efficacy and Safety of Pyrotinib, Trastuzumab Combined With Taxanes in the Treatment of Trastuzumab-treated HER2+ Advanced Breast Cancer (ABC). Recruiting
SHR2554 Combined With Endocrine Therapy in Advanced Breast Cancer Recruiting
Apatinib Combined With cdk4/6i in First-line Treatment for HR+/HER2- SNF4 Subtype Breast Cancer Active, not recruiting
Study of ADCs Combined With Adebrelimab in HER2-negative Advanced Breast Cancer Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07180082 on ClinicalTrials.gov ↗ ← All trials in China