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
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 964 (estimated) |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Drugs / interventions | pyrotinib |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | April 30, 2024 |
| Main results expected | April 30, 2025 |
| Study ends | April 30, 2027 |
| Registry record updated | May 6, 2025 |
| Trial ID | NCT06958627 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
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Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Principal investigator: Jiani Wang, M.D. — National Cancer Center Cancer Hospital
- Study coordinator: Jiani Wang, M.D.
- Email: ncc_wangjiani@126.com
- Phone: 86010877-88120
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Entinostat with Pyrotinib and Endocrine Therapy in HER2-positive, HR-positive Advanced Breast Cancer after Trastuzumab Failure
This study tests whether adding entinostat to pyrotinib and hormone therapy is safe and helps patients with advanced HR+/HER2+ breast cancer who progressed after trastuzumab.
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Pyrotinib plus trastuzumab and chemotherapy for HER2-positive early breast cancer
This study tests a treatment combination of Pyrotinib, Trastuzumab and chemo given before surgery to see if it can improve responses in HER2-positive breast cancer patients who have not yet been treated.
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Combining chemotherapy with pyrotinib and trastuzumab for HER2-positive breast cancer
This study is testing whether combining chemotherapy with two targeted drugs, pyrotinib and trastuzumab, can help people with HER2-positive breast cancer respond better to treatment before surgery.
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Using pyrotinib and trastuzumab for maintenance therapy in HER2-positive breast cancer
This study is testing if using the drugs pyrotinib and trastuzumab together can help people with advanced HER2-positive breast cancer stay healthier and prevent brain tumors after their initial treatment.
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Combining Pyrotinib and Capecitabine for HER2 Positive Early-stage Breast Cancer Treatment
This study is testing if combining two drugs, Pyrotinib and Capecitabine, can help women with early-stage HER2 positive breast cancer after surgery feel better compared to other treatments their doctors choose.
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Using Pyrotinib to Reduce Recurrence Risk in Early Stage HER2-positive Breast Cancer
This study is testing if the drug pyrotinib can help reduce the chances of breast cancer coming back in women with early stage HER2-positive breast cancer who haven't fully responded to previous treatments.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.