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Trial Title:
The Real World Study of Pyrotinib in the Treatment of Advanced Breast Cancer With HER2 Positive
NCT ID:
NCT06495541
Condition:
Breast Cancer
RWS
Pyrotinib
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Pyrotinib
Description:
Administration method: Pyrrolitinib standard dose: 400 mg once a day, oral administration
within 30 minutes after breakfast, continuous administration for 21 days per cycle. The
dosage can be determined by the doctor according to the actual situation Make
adjustments. Other medications: The doctor selects the medication plan based on the
actual situation.
Arm group label:
Pyrotinib
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 the treatment of HER2 positive
advanced first-line breast cancer.
Secondary research objectives:
1. Evaluate the correlation between patient characteristics in the late stage of
treatment and specific treatment plans and clinical outcomes Sex (including safety
outcomes)
2. Evaluate whether and how previous anti HER2 therapy affects the efficacy of
subsequent pyrrolitinib treatment
3. To observe the efficacy of pyrrolitinib in patients with brain metastasis of HER2
positive breast cancer
Research endpoint:
Main research endpoint:
Progression free survival (rwPFS)
Secondary study endpoint:
Efficacy endpoints: objective response rate (rwORR), disease control rate (rwDCR), until
treatment failure Time to Flight (TTF), Total Survival (OS), Security
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 positive patients. The medication regimen is not
restricted, Fully follow the clinical choices of doctors and evaluate the clinical
benefits of using different modes of pyrrolitinib (PFS) and security. The imaging
evaluation is based on the RECIST 1.1 standard and is conducted by reference to the The
research center conducts tumor efficacy evaluation. Patients using pyrrolitinib need to
undergo a safety visit on the 28th day of the last administration, and thereafter Enter
survival follow-up until patient death or trial termination (whichever occurs first).
Administration method: Pyrrolitinib standard dose: 400 mg once a day, oral administration
within 30 minutes after breakfast, continuous administration for 21 days per cycle. The
dosage can be determined by the doctor according to the actual situation Make
adjustments. Other medications: The doctor selects the medication plan based on the
actual situation.
Inclusion criteria:
1. Age ≥ 18 years old;
2. 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);
3. There is a traceable medical history record during the treatment period;
4. Voluntarily participate in this study, sign informed consent, have good compliance,
and are willing to cooperate Follow up.
Exclusion criteria:
1. Failure to sign informed consent form;
2. Previous history of other malignant tumors, but cured skin basal cell carcinoma and
cervical cancer Excluding cancer;
3. Difficulty in swallowing, chronic diarrhea, and intestinal obstruction, which can
affect medication administration and absorption Various factors;
4. Pregnant or lactating women, and women of childbearing age who cannot achieve
optimal contraception;
5. Any other circumstances in which the researcher deems the patient unsuitable to
participate in this study.
Research principle: In the first-line treatment of HER2 positive breast cancer with
pyrrolitinib, trastuzumab and docetaxel, the median PFS assessed by the investigator as
the primary endpoint was 24.3 months, and the ORR was 88%.
Approved by the National Medical Products Administration (NMPA) for HER2 positive in
April 2023 First line treatment of sexual breast cancer and all indications of
pyrrolidine will be covered by medical insurance in 2024 Cover. Pyrrolitinib is currently
registered for research and development in neoadjuvant, adjuvant, and advanced stages The
research is currently underway, all of which are RCT studies, but there is currently no
real-world data available I hope to further verify the efficacy of pyrrolitinib in
treating HER2 positive advanced first-line breast cancer in the real world The efficacy
and safety of adenocarcinoma.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≥ 18 years old;
2. 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);
3. There is a traceable medical history record during the treatment period;
4. Voluntarily participate in this study, sign informed consent, have good compliance,
and are willing to cooperate Follow up.
Exclusion Criteria:
1. Failure to sign informed consent form;
2. Previous history of other malignant tumors, but cured skin basal cell carcinoma and
cervical cancer Excluding cancer;
3. Difficulty in swallowing, chronic diarrhea, and intestinal obstruction, which can
affect medication administration and absorption Various factors;
4. Pregnant or lactating women, and women of childbearing age who cannot achieve
optimal contraception;
5. Any other circumstances in which the researcher deems the patient unsuitable to
participate in this study.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
August 1, 2024
Completion date:
July 30, 2028
Lead sponsor:
Agency:
Tianjin Medical University Cancer Institute and Hospital
Agency class:
Other
Source:
Tianjin Medical University Cancer Institute and Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06495541
