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

NCT ID: NCT04158505

Last Updated: 2020-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-28

Study Completion Date

2023-11-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HER2-positive Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

non-interventional study

non-interventional

Intervention Type OTHER

This prospective, observational study will be conducted according to each site's routine clinical practice

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

non-interventional

This prospective, observational study will be conducted according to each site's routine clinical practice

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chinese Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Binghe Xu

chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

National Cancer Center, Cancer Hospital/Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Xu Binghe

Role: CONTACT

+86-10-87788120

Li Yiqun

Role: CONTACT

+86-10-87788120

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Xu Binghe, M.D.

Role: primary

86-10-88788826

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HR-BLTN-016

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pyrotinib in HER2-positive Early Breast Cancer
NCT06718335 NOT_YET_RECRUITING NA