HER2 Positive Breast CancerPhase 2/3anyNCT06958627
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
A Phase 2/3 study testing pyrotinib in people with HER2 Positive Breast Cancer and Pyrotinib Treatment, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HER2 Positive Breast Cancer, Pyrotinib Treatment
- What is being tested?
- pyrotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 964 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2024to 30 Apr 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Fei Ma, 86-10-87788060, drmafei@126.com
About this study
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.
- Conditions
- HER2 Positive Breast Cancer, Pyrotinib Treatment
- Being tested
- pyrotinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pyrotinibDrug
Intelligent patient management system on medication adherence of HER2 positive breast cancer patients receiving pyrotinib treatment.
| Study group | Role | What they receive |
|---|---|---|
| intelligent patient management model | Experimental | Not described Receives: Drug: pyrotinib |
| traditional patient management model | Active comparator | Not described Receives: Drug: pyrotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
medication adherence at 1-year
medication adherence at 1-year is assessed using the tablet counting method and Eight-Item Morisky Medication Adherence Scale Evaluation Method 1: Tablet Counting Method
- Definition/Formula: Adherence percentage = (Actual tablets taken / Total tablets prescribed) * 100% (Actual tablets taken = Total prescribed tablets - Remaining tablets - Lost tablets)
- Procedure:
At the screening phase and Day 21 of each cycle, calculate the adherence percentage based on APP check-ins, and confirm the actual remaining tablets through follow-up.
Evaluation Method 2: MMAS-8 Scale
（1）Definition:
The Morisky Medication Adherence Scale-8 (MMAS-8) is a validated 8-item questionnaire. The total score ranges from 0 to 8, with higher scores indicating better adherence:
8: Good adherence 6-7: Moderate adherence <6: Poor adherence （2）Procedure: Administer the MMAS-8 scale at the screening phase and Day 21 of each cycle. The total score is calculated as the sum of scores from the 8 questions.
Measured: 1-year
Secondary outcomes (4)
The time to deterioration (TTD)
TTD is defined as the time from randomization to confirmation of the first clinically significant deterioration (deterioration ≥ 10 points) in subsequent follow-up or death
Measured: time from the date of randomization to the date of the first clinically significant deterioration through study completion, an average of 2 year
Event-free survival (EFS)
EFS (defined as the time from randomization to the first documentation of progressing disease while on study therapy, postoperative disease recurrence, or death from any cause)
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.
Overall survival (OS)
the time from randomisation to death from any cause
Measured: From date of randomization until the date of death from any cause, assessed up to 4 years
PRO
EORTC QLQ-C30 and NCC-BC-A1.0 questionnaire：
- Outcome Measure 1 （1）Description: Scale Full Name: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Score Range:Global Health Status/QoL Scale: 0-100. Functional Scales (e.g., Physical, Role): 0-100. Symptom Scales (e.g., Fatigue): 0-100. （2）Interpretation: Higher scores on Global Health Status/QoL and Functional Scales indicate better outcomes.Higher scores on Symptom Scales indicate worse outcomes.
- Outcome Measure 2 （1）Description: Scale Full Name: National Cancer Center Breast Cancer-Specific Patient-Reported Outcome Scale Version 1.0 (NCC-BC-A1.0). Score Range:Total Score: 38-190 points (each item scored 1-5). （2）Interpretation:Higher total scores indicate poorer quality of life (for symptom-related items).Lower scores on positive function items (e.g., confidence, support) indicate worse outcomes.
- Time Frame: Baseline, every 2 cycles, and at end of treatment.
Measured: From date of randomization until the date of death from any cause, assessed up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start30 Apr 2024
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HER2 Positive Breast CancerStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled clinical study
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 964 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ma Fei，MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Jiani Wang, M.D., Principal investigator, National Cancer Center Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06958627
- Sponsor's protocol ID
- NCC4587
- Acronym
- any
- Status last verified
- Apr 2025
- First submitted
- 26 Apr 2024
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD Description: Individual participant data will not be shared to protect patient privacy. The study involves sensitive clinical and behavioral data, and even de-identified datasets carry residual re-identification risks. Data access is restricted to the research team under ethical and legal obligations. Access Criteria: N/A IPD Sharing URL: N/A
Publications
Koehler F, Koehler K, Prescher S, Kirwan BA, Wegscheider K, Vettorazzi E, Lezius S, Winkler S, Moeller V, Fiss G, Schleder J, Koehler M, Zugck C, Stork S, Butter C, Prondzinsky R, Spethmann S, Angermann C, Stangl V, Halle M, von Haehling S, Dreger H, Stangl K, Deckwart O, Anker SD. Mortality and morbidity 1 year after stopping a remote patient management intervention: extended follow-up results from the telemedical interventional management in patients with heart failure II (TIM-HF2) randomised trial. Lancet Digit Health. 2020 Jan;2(1):e16-e24. doi: 10.1016/S2589-7500(19)30195-5. Epub 2019 Dec 12.
PubMed 33328035
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06958627
- Acronym / sponsor ID
- any / NCC4587
- Conditions
- HER2 Positive Breast Cancer, Pyrotinib Treatment
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 964 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 6 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- randomized controlled clinical study
| Arm | Type | Receives |
|---|---|---|
| intelligent patient management model | Experimental | Drug: pyrotinib |
| traditional patient management model | Active comparator | Drug: pyrotinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pyrotinibIntelligent patient management system on medication adherence of HER2 positive breast cancer patients receiving pyrotinib treatment. | Drug | intelligent patient management model, traditional patient management model |
Primary outcome
medication adherence at 1-year
Time frame: 1-year
medication adherence at 1-year is assessed using the tablet counting method and Eight-Item Morisky Medication Adherence Scale Evaluation Method 1: Tablet Counting Method 1. Definition/Formula: Adherence percentage = (Actual tablets taken / Total tablets prescribed) * 100% (Actual tablets taken = Total prescribed tablets - Remaining tablets - Lost tablets) 2. Procedure: At the screening phase and Day 21 of each cycle, calculate the adherence percentage based on APP check-ins, and confirm the actual remaining tablets through follow-up. Evaluation Method 2: MMAS-8 Scale （1）Definition: The Morisky Medication Adherence Scale-8 (MMAS-8) is a validated 8-item questionnaire. The total score ranges from 0 to 8, with higher scores indicating better adherence: 8: Good adherence 6-7: Moderate adherence <6: Poor adherence （2）Procedure: Administer the MMAS-8 scale at the screening phase and Day 21 of each cycle. The total score is calculated as the sum of scores from the 8 questions.
4 secondary outcomes
The time to deterioration (TTD)
Time frame: time from the date of randomization to the date of the first clinically significant deterioration through study completion, an average of 2 year
Event-free survival (EFS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.
Overall survival (OS)
Time frame: From date of randomization until the date of death from any cause, assessed up to 4 years
PRO
Time frame: From date of randomization until the date of death from any cause, assessed up to 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Results publication: PubMed 33328035Koehler F, Koehler K, Prescher S, Kirwan BA, Wegscheider K, Vettorazzi E, Lezius S, Winkler S, Moeller V, Fiss G, Schleder J, Koehler M, Zugck C, Stork S, Butter C, Prondzinsky R, Spethmann S, Angermann C, Stangl V, Halle M, von Haehling S, Dreger H, Stangl K, Deckwart O, Anker SD. Mortality and morbidity 1 year after stopping a remote patient management intervention: extended follow-up results from the telemedical interventional management in patients with heart failure II (TIM-HF2) randomised trial. Lancet Digit Health. 2020 Jan;2(1):e16-e24. doi: 10.1016/S2589-7500(19)30195-5. Epub 2019 Dec 12.
- Individual participant dataSharing planned: No. IPD Description: Individual participant data will not be shared to protect patient privacy. The study involves sensitive clinical and behavioral data, and even de-identified datasets carry residual re-identification risks. Data access is restricted to the research team under ethical and legal obligations. Access Criteria: N/A IPD Sharing URL: N/A
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jiani Wang, M.D. principal investigator
National Cancer Center Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing pyrotinib in people with HER2 Positive Breast Cancer and Pyrotinib Treatment, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiani Wang, M.D. (86010877-88120, ncc_wangjiani@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
medication adherence at 1-year (time frame: 1-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06958627, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.