Status:
RECRUITING
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
Lead Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions:
HER2 Positive Breast Cancer
Pyrotinib Treatment
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
PHASE3
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 pa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2027
Estimated Enrollment :
964 Patients enrolled
Trial Details
Trial ID
NCT06958627
Start Date
April 30 2024
End Date
April 30 2027
Last Update
May 6 2025
Active Locations (1)
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1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021