Real World Study of Pyrotinib in Human Epidermal Growth Factor Receptor-2 (HER2) Positive Breast Cancer
- Conditions
- HER2-positive Breast Cancer
- Interventions
- Other: non-interventional
- Registration Number
- NCT04158505
- Lead Sponsor
- Chinese Academy of Medical Sciences
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 3000
Inclusion Criteria
- ≥18 years old with histologically confirmed HER2 positive breast cancer.
- Documented HER2 overexpression by local laboratory ,defined as immunohistochemistry (IHC) 3+ or fluorescence in situ hybridization (FISH) positive.
- Physician has determined that treatment with pyrotinib is indicated.
- Traceable medical record available.
Exclusion Criteria
- Patients who are unable to understand the nature of the study and are unwilling to sign an informed consent .
- Pregnant or breast feeding patients
- Patients participating in any interventional clinical trial that includes investigational or marketed products at the time of enrollment.
- Patients not suitable for this study under investigators' consideration.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description non-interventional study non-interventional -
- Primary Outcome Measures
Name Time Method 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
Progression Free Survival(PFS) 12 months Progression Free Survival(PFS)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
National Cancer Center, Cancer Hospital/Chinese Academy of Medical Sciences and Peking Union Medical College
🇨🇳Beijing, Beijing, China