Clinical trial Recruiting at 1 site Phase2; Phase3 Interventional Ages 18 and up Women only

Evaluating an intelligent management system for medication adherence in breast cancer treatment

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

Run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · NCT06958627 · Data updated 2026-11-12

This study is testing a new patient management system to see if it helps women with HER2-positive breast cancer stick to their medication better than usual methods while they receive pyrotinib treatment.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Ages18 Years and up
SexWomen only
Enrollment964 (estimated)
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
Academic / other
Drugs / interventionspyrotinib
Locations1 site (Beijing, Beijing Municipality)
StatusRecruiting
StartedApril 30, 2024
Main results expectedApril 30, 2025
Study endsApril 30, 2027
Registry record updatedMay 6, 2025
Trial IDNCT06958627 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are female patients aged 18 and older with histologically confirmed HER2-positive breast cancer who are expected to receive pyrotinib.

Probably not a fit

Patients with cognitive impairments, severe sensory disabilities, or those who have previously used pyrotinib may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the effectiveness of an intelligent patient management model on medication adherence among female patients with HER2-positive breast cancer receiving pyrotinib. It is a multicenter, randomized controlled study that compares this innovative approach to traditional patient management methods. The trial will include patients who are expected to undergo pyrotinib treatment for neoadjuvant therapy or metastatic breast cancer. Participants will be monitored for their ability to adhere to the medication regimen, which is crucial for treatment success.

Why it matters

Potential benefit: If successful, this study could significantly improve medication adherence, leading to better treatment outcomes for patients with HER2-positive breast cancer.

How similar studies have gone: While the specific approach of using an intelligent management system is novel, similar studies have shown that enhanced patient management can improve medication adherence.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Cancer Hospital, Chinese Academy of Medical Sciences
    Beijing, Beijing Municipality, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.