Overview

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

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.