Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06958627

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

HER2 Positive Breast Cancer Pyrotinib Treatment

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location status: Recruiting

Location contact

Fei Ma

CONTACT

[email protected]

86-10-87788060

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pyrotinib

Drug

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

Primary outcomes

  1. medication adherence at 1-year

    Time frame: 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.

Secondary outcomes

  1. The time to deterioration (TTD)

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

    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

  2. Event-free survival (EFS)

    Time frame: 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.

    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)

  3. Overall survival (OS)

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

    the time from randomisation to death from any cause

  4. PRO

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiani Wang, M.D.

CONTACT

[email protected]

86010877-88120

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Acronym: any

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
May 6, 2025
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.