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
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Phase
Phase 2/3
Started
2024-04-30
Last updated
2025-05-06
Condition(s) studied
HER2 Positive Breast CancerPyrotinib Treatment
Investigational drug(s) / intervention(s)
pyrotinib
pyrotinib: Intelligent patient management system on medication adherence of HER2 positive breast cancer patients receiving pyrotinib treatment.
Study 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
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
medication adherence at 1-year — 1-year medication adherence at 1-year is assessed using the tablet counting method and Eight-Item Morisky Medication Adherence Scale Evaluation Method 1: Tablet Counting Method
1. Definition/Formula:
Adherence percentage = (Actual tablets taken / Total tablets prescribed) \* 100% (Actual tablets taken = Total prescribed tablets - Remaining tablets - Lost tablets)
2. Procedure:
At the screening phase and Day 21 of each cycle, calculate the adherence percentage based on APP check-ins, and confirm the actual remaining tablets through follow-up.
Evaluation Method 2: MMAS-8 Scale
（1）Definition:
The Morisky Medication Adherence Scale-8 (MMAS-8) is a validated 8-item questionnaire. The total score ranges from 0 to 8, with higher scores indicating better adherence:
8: Good adherence 6-7: Moderate adherence \<6: Poor adherence （2）Procedure: Administer the MMAS-8 scale at the screening phase and Day 21 of each cycle. The total score is calculated as the sum of scores from the 8 questions.
Trial sites (1)
Facility
City
Region
Status
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing
Beijing Municipality
Recruiting
More Cancer Institute and Hospital, Chinese Academy of Medical Sciences trials in China
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.
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