Status:

NOT_YET_RECRUITING

The Real World Study of Pyrotinib in the Treatment of Advanced Breast Cancer With HER2 Positive

Lead Sponsor:

Tianjin Medical University Cancer Institute and Hospital

Conditions:

Breast Cancer

RWS

Eligibility:

FEMALE

18+ years

Phase:

NA

Brief Summary

Research object:Planned to receive pyrrolidine for HER2 positive first-line breast cancer patients Research purpose: Main research objectives: To observe the efficacy and safety of pyrrolidine in t...

Detailed Description

Overall Study Design: This study adopts a prospective, multicenter, and observational design, with a planned enrollment of 500 first-line patients who plan to receive pyrrolitinib treatment for HER2 p...

Eligibility Criteria

Inclusion

  • Age ≥ 18 years old;
  • Pathological or histopathological confirmed HER2 positive cases cannot be surgically advanced or metastasized Patients with sexual breast cancer (HER2 positive is defined as: standard immunohistochemistry (IHC) Detected as 3+or ISH positive);
  • There is a traceable medical history record during the treatment period;
  • Voluntarily participate in this study, sign informed consent, have good compliance, and are willing to cooperate Follow up.

Exclusion

  • Failure to sign informed consent form;
  • Previous history of other malignant tumors, but cured skin basal cell carcinoma and cervical cancer Excluding cancer;
  • Difficulty in swallowing, chronic diarrhea, and intestinal obstruction, which can affect medication administration and absorption Various factors;
  • Pregnant or lactating women, and women of childbearing age who cannot achieve optimal contraception;
  • Any other circumstances in which the researcher deems the patient unsuitable to participate in this study.

Key Trial Info

Start Date :

August 1 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 30 2028

Estimated Enrollment :

500 Patients enrolled

Trial Details

Trial ID

NCT06495541

Start Date

August 1 2024

End Date

July 30 2028

Last Update

July 10 2024

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The Real World Study of Pyrotinib in the Treatment of Advanced Breast Cancer With HER2 Positive | DecenTrialz