HER2 Positive Breast Cancer, Pyrotinib Treatment
Conditions
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.
Interventions
DRUGpyrotinib
Intelligent patient management system on medication adherence of HER2 positive breast cancer patients receiving pyrotinib treatment.
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)
Intervention model description
randomized controlled clinical study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
| 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. | 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) |
| Overall survival (OS) | 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 |
| PRO | 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： 1. 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. 2. 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. 3. Time Frame: Baseline, every 2 cycles, and at end of treatment. |
Countries
China
Contacts
Primary ContactJiani Wang, M.D.
Outcome results
None listed