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
| NCT ID | NCT06958627 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
| Condition | HER2 Positive Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 964 participants |
| Start Date | 2024-04-30 |
| Primary Completion | 2025-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 964 participants in total. It began in 2024-04-30 with a primary completion date of 2025-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Jiani Wang, M.D.
PRINCIPAL INVESTIGATOR
National Cancer Center Cancer Hospital
Frequently Asked Questions
Who can join the NCT06958627 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying HER2 Positive Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06958627 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06958627 currently recruiting?
Yes, NCT06958627 is actively recruiting participants. Contact the research team at ncc_wangjiani@126.com for enrollment information.
Where is the NCT06958627 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06958627 clinical trial?
NCT06958627 is sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. The principal investigator is Jiani Wang, M.D. at National Cancer Center Cancer Hospital. The trial plans to enroll 964 participants.
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