Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: HER2 Positive Breast Cancer
Pyrotinib Treatment
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2025-05-06
Enrollment: 964
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled clinical study
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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.

Primary outcomes:
measure: medication adherence at 1-year
timeFrame: 1-year
Secondary outcomes:
measure: The time to deterioration (TTD)
timeFrame: time from the date of randomization to the date of the first clinically significant deterioration through study completion, an average of 2 year
measure: Event-free survival (EFS)
timeFrame: 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.
measure: Overall survival (OS)
timeFrame: From date of randomization until the date of death from any cause, assessed up to 4 years
measure: PRO
timeFrame: From date of randomization until the date of death from any cause, assessed up to 4 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: National Cancer Center Cancer Hospital
name: Jiani Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.