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The Impact of Intelligent Patient Management Model on Medication Adherence of Pyrotinib Compared to Traditional Patient Management Model: a Prospective, Multicenter, Randomized Controlled Clinical Study

This is a prospective, multicenter, randomized controlled clinical study to evaluate the effect of using intelligent patient management system on medication adherence of HER2 positive breast cancer patients receiving pyrotinib treatment. Pyrotinib is a small molecule tyrosine kinase inhibitor that can irreversibly inhibit HER1, HER2, and HER4.

ClinicalTrials.gov IDNCT06958627
PhasePHASE2, PHASE3
Enrollment964
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
Age18 Years and older
SexFEMALE
I'm interested View official listing

Conditions studied

HER2 Positive Breast Cancer, Pyrotinib Treatment

About this study

This is a prospective, multicenter, randomized controlled clinical study to evaluate the effect of using intelligent patient management system on medication adherence of HER2 positive breast cancer patients receiving pyrotinib treatment. Pyrotinib is a small molecule tyrosine kinase inhibitor that can irreversibly inhibit HER1, HER2, and HER4.

Interventions

Primary outcomes

Eligibility information

Inclusion Criteria: * Female patients aged ≥ 18 years. * Histologically confirmed HER2-positive breast cancer (IHC 3+ or IHC 2+ with ISH+). * Patients expected to receive pyrotinib-containing regimens for neoadjuvant therapy or metastatic/unresectable breast cancer. ·≤1 prior line of anti-HER2 therapy during the recurrent/metastatic stage. * Ability to operate a mobile phone and read independently. * Deemed psychologically and physically suitable for participation by the investigator. Exclusion Criteria: * History of cognitive impairment. * Severe visual or auditory impairments. * Prior use of pyrotinib. * Pregnancy, lactation, or intention to conceive. * Ineffective cognitive-behavioral interventions within the past year. * Participation in other clinical trials within 1 month prior to screening. * Investigator judgment of unsuitability due to psychological or physical conditions.

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-15.