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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: HER2-positive Breast Cancer

Treatments: Other: non-interventional

Study type: Observational

Funder types: Other

Identifiers

NCT04158505

HR-BLTN-016

Details and patient eligibility

About

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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

3,000 participants in 1 patient group

non-interventional study

Treatment:

Other: non-interventional