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

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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

Tracking Information
First Submitted Date November 7, 2019
First Posted Date November 8, 2019
Last Update Posted Date November 8, 2019
Estimated Study Start Date November 15, 2019
Estimated Primary Completion Date November 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 7, 2019)
  • 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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Real World Study of Pyrotinib in Human Epidermal Growth Factor Receptor-2 (HER2) Positive Breast Cancer
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)
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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 2 Years
Biospecimen Not Provided
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
Condition HER2-positive Breast Cancer
Intervention Other: non-interventional
This prospective, observational study will be conducted according to each site's routine clinical practice
Study Groups/Cohorts non-interventional study
Intervention: Other: non-interventional
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: November 7, 2019)
3000
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 15, 2023
Estimated Primary Completion Date November 15, 2021   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Xu Binghe +86-10-87788120 xubinghe@medmail.com.cn
Contact: Li Yiqun +86-10-87788120 Liyiqun_chcams@foxmail.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04158505
Other Study ID Numbers HR-BLTN-016
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Binghe Xu, Chinese Academy of Medical Sciences
Study Sponsor Chinese Academy of Medical Sciences
Collaborators Not Provided
Investigators Not Provided
PRS Account Chinese Academy of Medical Sciences
Verification Date November 2019