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

April 23, 2020 updated by: Binghe Xu, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100021
        • Recruiting
        • National Cancer Center, Cancer Hospital/Chinese Academy of Medical Sciences and Peking Union Medical College
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
non-interventional study
Other: non-interventional
This prospective, observational study will be conducted according to each site's routine clinical practice

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2020

Primary Completion (Anticipated)

November 15, 2021

Study Completion (Anticipated)

November 15, 2023

Study Registration Dates

First Submitted

November 7, 2019

First Submitted That Met QC Criteria

November 7, 2019

First Posted (Actual)

November 8, 2019

Study Record Updates

Last Update Posted (Actual)

April 24, 2020

Last Update Submitted That Met QC Criteria

April 23, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HR-BLTN-016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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