The Real World Study of Pyrotinib in the Treatment of Advanced Breast Cancer With HER2 Positive
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pyrotinib.
- Who it may be relevant to
- Registry conditions: Breast Cancer, RWS, Pyrotinib. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Pyrotinib
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.
Primary outcome measures
- PFS [Time frame: 24.3months]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06495541 · Tianjin Cancer Hospital..