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 (any)

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.

Study Overview

• Status: Recruiting
• Conditions: HER2 Positive Breast Cancer; Pyrotinib Treatment
• Intervention / Treatment: Drug: pyrotinib

• Study Type: Interventional
• Enrollment (Estimated): 964
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Jiani Wang, M.D.; Phone Number: 86010877-88120; Email: ncc_wangjiani@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Recruiting
      • Cancer Hospital, Chinese Academy of Medical Sciences
      • Contact: Fei Ma; Phone Number: 86-10-87788060; Email: drmafei@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intelligent patient management model	Drug: pyrotinib; Intelligent patient management system on medication adherence of HER2 positive breast cancer patients receiving pyrotinib treatment.
Active Comparator: traditional patient management model	Drug: pyrotinib; Intelligent patient management system on medication adherence of HER2 positive breast cancer patients receiving pyrotinib treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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; Definition/Formula:Adherence percentage = (Actual tablets taken / Total tablets prescribed) * 100% (Actual tablets taken = Total prescribed tablets - Remaining tablets - Lost tablets); 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The time to deterioration (TTD)	TTD is defined as the time from randomization to confirmation of the first clinically significant deterioration (deterioration ≥ 10 points) in subsequent follow-up or death	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)	EFS (defined as the time from randomization to the first documentation of progressing disease while on study therapy, postoperative disease recurrence, or death from any cause)	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)	the time from randomisation to death from any cause	From date of randomization until the date of death from any cause, assessed up to 4 years
PRO	EORTC QLQ-C30 and NCC-BC-A1.0 questionnaire： Outcome Measure 1 （1）Description: Scale Full Name: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).Score Range:Global Health Status/QoL Scale: 0-100. Functional Scales (e.g., Physical, Role): 0-100. Symptom Scales (e.g., Fatigue): 0-100. （2）Interpretation: Higher scores on Global Health Status/QoL and Functional Scales indicate better outcomes.Higher scores on Symptom Scales indicate worse outcomes.; Outcome Measure 2 （1）Description: Scale Full Name: National Cancer Center Breast Cancer-Specific Patient-Reported Outcome Scale Version 1.0 (NCC-BC-A1.0).Score Range:Total Score: 38-190 points (each item scored 1-5). （2）Interpretation:Higher total scores indicate poorer quality of life (for symptom-related items).Lower scores on positive function items (e.g., confidence, support) indicate worse outcomes.; Time Frame: Baseline, every 2 cycles, and at end of treatment.	From date of randomization until the date of death from any cause, assessed up to 4 years

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Investigators: Principal Investigator: Jiani Wang, M.D., National Cancer Center Cancer Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2024
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: April 26, 2024
• First Submitted That Met QC Criteria: April 27, 2025
• First Posted (Actual): May 6, 2025

Study Record Updates

• Last Update Posted (Actual): May 6, 2025
• Last Update Submitted That Met QC Criteria: April 27, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: NCC4587

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

IPD Description: Individual participant data will not be shared to protect patient privacy. The study involves sensitive clinical and behavioral data, and even de-identified datasets carry residual re-identification risks. Data access is restricted to the research team under ethical and legal obligations.

Access Criteria: N/A IPD Sharing URL: N/A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No