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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04158505
Recruitment Status : Not yet recruiting
First Posted : November 8, 2019
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
Binghe Xu, Chinese Academy of Medical Sciences

Brief 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.

Condition or disease Intervention/treatment
HER2-positive Breast Cancer Other: non-interventional

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
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)
Estimated Study Start Date : November 15, 2019
Estimated Primary Completion Date : November 15, 2021
Estimated Study Completion Date : November 15, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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




Primary Outcome Measures :
  1. Progression Free Survival(PFS) [ Time Frame: 12 months ]
    Progression Free Survival(PFS)

  2. Pathological Complete Response(pCR)Rate [ Time Frame: through study completion, an average of 1 year ]
    Percentage of Participants With Pathological Complete Response

  3. Incidences of adverse events and toxicities [ Time Frame: through study completion, an average of 1 year ]
    Incidences of adverse events and toxicities



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04158505


Contacts
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Contact: Xu Binghe +86-10-87788120 xubinghe@medmail.com.cn
Contact: Li Yiqun +86-10-87788120 Liyiqun_chcams@foxmail.com

Locations
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China, Beijing
National Cancer Center, Cancer Hospital/Chinese Academy of Medical Sciences and Peking Union Medical College Recruiting
Beijing, Beijing, China, 100021
Contact: Xu Binghe, M.D.    86-10-88788826    xubinghe@medmail.com.cn   
Sponsors and Collaborators
Chinese Academy of Medical Sciences

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Responsible Party: Binghe Xu, chief physician, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT04158505     History of Changes
Other Study ID Numbers: HR-BLTN-016
First Posted: November 8, 2019    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Binghe Xu, Chinese Academy of Medical Sciences:
pyrotinib
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases