HER2-positive Breast Cancer
Conditions
Keywords
pyrotinib
Brief summary
This Non-Interventional Study will describe and analyze the clinical use of pyrotinib in clinical practice in the treatment of HER2 positive breast cancer in the real world.
Interventions
OTHERnon-interventional
This prospective, observational study will be conducted according to each site's routine clinical practice
Sponsors
Chinese Academy of Medical Sciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ≥18 years old with histologically confirmed HER2 positive breast cancer. 2. Documented HER2 overexpression by local laboratory ,defined as immunohistochemistry (IHC) 3+ or fluorescence in situ hybridization (FISH) positive. 3. Physician has determined that treatment with pyrotinib is indicated. 4. Traceable medical record available.
Exclusion criteria
1. Patients who are unable to understand the nature of the study and are unwilling to sign an informed consent . 2. Pregnant or breast feeding patients 3. Patients participating in any interventional clinical trial that includes investigational or marketed products at the time of enrollment. 4. Patients not suitable for this study under investigators' consideration.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival(PFS) | 12 months | Progression Free Survival(PFS) |
| Pathological Complete Response（pCR）Rate | through study completion, an average of 1 year | Percentage of Participants With Pathological Complete Response |
| Incidences of adverse events and toxicities | through study completion, an average of 1 year | Incidences of adverse events and toxicities |
Countries
China
Contacts
Primary ContactXu Binghe
Backup ContactLi Yiqun
Outcome results
None listed