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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 | Clinical Trials | Clareo Health

RECRUITINGPHASE2/PHASE3

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

NCT06958627•Cancer Institute and Hospital, Chinese Academy of Medical Sciences

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Yes

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.

Locations (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Key Dates

Start Date

April 30, 2024

Primary Completion Date

April 30, 2025

Completion Date

April 30, 2027

Last Updated

May 6, 2025

Enrollment

964

ESTIMATED participants

Conditions

HER2 Positive Breast CancerPyrotinib Treatment

Interventions

pyrotinib

DRUG

Contacts

Jiani Wang, M.D.

CONTACT

86010877-88120 ncc_wangjiani@126.com

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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: May 6, 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.

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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

Inclusion Criteria

Exclusion Criteria

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