Ignite Creation Date:
2024-07-17 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06495541
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-07-03
Brief Title:
The Real World Study of Pyrotinib in the Treatment of Advanced Breast Cancer With HER2 Positive
Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Organization:
Tianjin Medical University Cancer Institute and Hospital
Study Overview
Official Title:
The Real World Study of Pyrotinib in the Treatment of Advanced Breast Cancer With HER2 Positive
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Research objectPlanned 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
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 11 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 3or 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 243 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
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 3or 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 243 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None