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

Overview

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.

Full Title of Study: “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)”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 15, 2021

Interventions

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

Arms, Groups and Cohorts

  • non-interventional study

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chinese Academy of Medical Sciences
  • Provider of Information About this Clinical Study
    • Principal Investigator: Binghe Xu, chief physician – Chinese Academy of Medical Sciences
  • Overall Contact(s)
    • Xu Binghe, +86-10-87788120, xubinghe@medmail.com.cn

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