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
Recruiting
Phase 2
Phase 3
Interventional Study
HER2 Positive Breast Cancer
Pyrotinib Treatment
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Health Services Research
- Participants needed
- 964 (estimated)
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Other
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About This Trial
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.
Trial Locations
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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 t…
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