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 | Recruiting Phase 2

• 1 other identifier: NCC4587
• Study Type: interventional
• Target: 964
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HER2 Positive Breast Cancer; Pyrotinib Treatment

Outcome Measures

Primary Outcomes (1)

• medication adherence at 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.

  1-year

Secondary Outcomes (4)

• The time to deterioration (TTD)

  time from the date of randomization to the date of the first clinically significant deterioration through study completion, an average of 2 year

• Event-free survival (EFS)

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.

• Overall survival (OS)

  From date of randomization until the date of death from any cause, assessed up to 4 years

• PRO

  From date of randomization until the date of death from any cause, assessed up to 4 years

Study Arms (2)

intelligent patient management model

EXPERIMENTAL

Drug: pyrotinib

traditional patient management model

ACTIVE COMPARATOR

Drug: pyrotinib

Interventions

pyrotinib DRUG

Intelligent patient management system on medication adherence of HER2 positive breast cancer patients receiving pyrotinib treatment.

intelligent patient management model; traditional patient management model

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Related Publications (1)

• Koehler F, Koehler K, Prescher S, Kirwan BA, Wegscheider K, Vettorazzi E, Lezius S, Winkler S, Moeller V, Fiss G, Schleder J, Koehler M, Zugck C, Stork S, Butter C, Prondzinsky R, Spethmann S, Angermann C, Stangl V, Halle M, von Haehling S, Dreger H, Stangl K, Deckwart O, Anker SD. Mortality and morbidity 1 year after stopping a remote patient management intervention: extended follow-up results from the telemedical interventional management in patients with heart failure II (TIM-HF2) randomised trial. Lancet Digit Health. 2020 Jan;2(1):e16-e24. doi: 10.1016/S2589-7500(19)30195-5. Epub 2019 Dec 12.

  PMID: 33328035 BACKGROUND

MeSH Terms

Interventions

pyrotinib

Study Officials

• Jiani Wang, M.D.

  National Cancer Center Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiani Wang, M.D.

CONTACT

86010877-88120; ncc_wangjiani@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Medical Oncology, Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College

Model Details: randomized controlled clinical study

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 6, 2025
• Study Start: April 30, 2024
• Primary Completion: April 30, 2025
• Study Completion (Estimated): April 30, 2027
• Last Updated: May 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)