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

Launched by CANCER INSTITUTE AND HOSPITAL, CHINESE ACADEMY OF MEDICAL SCIENCES · Apr 27, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring how an intelligent patient management system can help women with HER2-positive breast cancer stick to their medication plan while they are being treated with a drug called pyrotinib. Pyrotinib is designed to target and block specific cancer cells. The study aims to see if this new management approach is better than traditional methods in ensuring that patients take their medications as prescribed.

To participate in this study, women must be at least 18 years old and have been diagnosed with HER2-positive breast cancer. They should be planning to receive treatment that includes pyrotinib and have had limited previous anti-HER2 therapy. Participants will need to be able to use a mobile phone and read independently. Throughout the trial, patients can expect close monitoring and support related to their treatment. It's important to note that women who are pregnant, have certain health issues, or have recently participated in other clinical trials will not be eligible to join. This study is currently looking for participants, and it aims to help improve treatment outcomes for women facing this type of cancer.

Gender

FEMALE

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.