Real World Study of Pyrotinib in Human Epidermal Growth Factor Receptor-2 (HER2) Positive Breast Cancer
Real World Study on the Efficacy and Safety of Pyrotinib in the Treatment of HER2 Positive Breast Cancer: An Observational,Multi-center,Prospective Study (Real Pretty Study)
1 other identifier
observational
3,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 7, 2019
CompletedFirst Posted
Study publicly available on registry
November 8, 2019
CompletedStudy Start
First participant enrolled
February 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2023
CompletedApril 24, 2020
April 1, 2020
1.7 years
November 7, 2019
April 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Progression Free Survival(PFS)
Progression Free Survival(PFS)
12 months
Pathological Complete Response（pCR）Rate
Percentage of Participants With Pathological Complete Response
through study completion, an average of 1 year
Incidences of adverse events and toxicities
Incidences of adverse events and toxicities
through study completion, an average of 1 year
Study Arms (1)
non-interventional study
Interventions
This prospective, observational study will be conducted according to each site's routine clinical practice
Eligibility Criteria
HER2+ breast cancer patients whose treatment decision with pyrotinib has been made by their physician and who meet the eligibility criteria will be invited to participate in the study
You may qualify if:
- ≥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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Cancer Center, Cancer Hospital/Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100021, China
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- chief physician
Study Record Dates
First Submitted
November 7, 2019
First Posted
November 8, 2019
Study Start
February 28, 2020
Primary Completion
November 15, 2021
Study Completion
November 15, 2023
Last Updated
April 24, 2020
Record last verified: 2020-04