Real World Study of Pyrotinib in Human Epidermal Growth Factor Receptor-2 (HER2) Positive Breast Cancer

HER2-positive Breast Cancer Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04158505
• Other study ID #: HR-BLTN-016
• Status: Recruiting
• Start date: February 28, 2020
• Est. completion date: November 15, 2023

Study information

• Verified date: April 2020
• Source: Chinese Academy of Medical Sciences
• Contact: Xu Binghe
• Phone: +86-10-87788120
• Email: xubinghe[@]medmail.com.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: November 15, 2023
• Est. primary completion date: November 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• HER2-positive Breast Cancer

Intervention

Other:
• non-interventional
This prospective, observational study will be conducted according to each site's routine clinical practice

Locations

Country	Name	City	State
China	National Cancer Center, Cancer Hospital/Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival(PFS)	Progression Free Survival(PFS)	12 months
Primary	Pathological Complete Response(pCR)Rate	Percentage of Participants With Pathological Complete Response	through study completion, an average of 1 year
Primary	Incidences of adverse events and toxicities	Incidences of adverse events and toxicities	through study completion, an average of 1 year