The Real World Study of Pyrotinib in the Treatment of Advanced Breast Cancer With HER2 Positive
Real-world study of Pyrotinib for advanced HER2-positive breast cancer
Plain English Summary
The Real World Study of Pyrotinib in the Treatment of Advanced Breast Cancer With HER2 Positive is a Not Applicable clinical trial sponsored by Tianjin Medical University Cancer Institute and Hospital studying Breast Cancer, RWS, Pyrotinib. This study tests how well Pyrotinib works and its safety in treating advanced HER2-positive breast cancer. It is for patients with HER2-positive breast cancer that has spread and cannot be treated with surgery. Participation involves taking Pyrotinib daily and attending regular follow-up appointments. Alternatives may include other HER2-targeted therapies or chemotherapy, depending on prior treatments and doctor's recommendation. The trial aims to enroll 500 participants.
Official 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
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18 and older with confirmed HER2-positive advanced or metastatic breast cancer. Patients must have a traceable medical history and be willing to follow study procedures. Individuals with a history of other cancers (except cured skin or cervical cancer), severe swallowing or digestive issues, or who are pregnant/breastfeeding cannot participate. This trial is studying Breast Cancer, RWS, Pyrotinib, so participants generally need a confirmed diagnosis.
What They're Measuring
Progression-free survival (PFS) means the length of time patients live without their cancer getting worse. The specific primary outcome measures are: PFS (24.3months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial matters because it will provide real-world data on Pyrotinib's effectiveness and safety, filling a gap in understanding its use in a broader patient population beyond controlled clinical se This research targets Breast Cancer, RWS, Pyrotinib, where improved treatment options are needed.
Investor Insight
This study focuses on Pyrotinib, a targeted therapy for HER2-positive breast cancer, a significant market. Real-world data can support regulatory approval and market adoption.
Is This Trial Right for Me?
Ask your doctor about how Pyrotinib is given, potential side effects, and how it compares to other treatments. You will take Pyrotinib by mouth daily after breakfast and attend regular clinic visits for monitoring. Be prepared to share your medical history and cooperate with follow-up assessments. The trial is being conducted at multiple sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NA
- Model: SINGLE_GROUP
- Masking: NONE
- Enrollment: 500 participants
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 Outcomes
- PFS (24.3months)
Full 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.
Frequently Asked Questions
What is clinical trial NCT06495541?
NCT06495541 is a Not Applicable INTERVENTIONAL study titled "The Real World Study of Pyrotinib in the Treatment of Advanced Breast Cancer With HER2 Positive." It is currently not yet recruiting and is sponsored by Tianjin Medical University Cancer Institute and Hospital. The trial targets enrollment of 500 participants.
What conditions does NCT06495541 study?
This trial investigates treatments for Breast Cancer, RWS, Pyrotinib. The primary condition under study is Breast Cancer.
What treatments are being tested in NCT06495541?
The interventions being studied include: Pyrotinib (DRUG). 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.
What does Not Applicable mean for NCT06495541?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT06495541?
This trial is currently "Not Yet Recruiting." It started on 2026-04-01. The estimated completion date is 2028-07-30.
Who is sponsoring NCT06495541?
NCT06495541 is sponsored by Tianjin Medical University Cancer Institute and Hospital. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06495541?
The trial aims to enroll 500 participants. The trial has not yet started recruiting.
How is NCT06495541 designed?
This is a interventional study, uses na allocation, follows a single_group design, employs none masking.
What are the primary outcomes being measured in NCT06495541?
The primary outcome measures are: PFS (24.3months). These are the main endpoints researchers use to determine whether the treatment is effective.
Where can I find official information about NCT06495541?
The official record for NCT06495541 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06495541. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06495541 testing in simple terms?
This study tests how well Pyrotinib works and its safety in treating advanced HER2-positive breast cancer. It is for patients with HER2-positive breast cancer that has spread and cannot be treated with surgery.
Why is this trial significant?
This trial matters because it will provide real-world data on Pyrotinib's effectiveness and safety, filling a gap in understanding its use in a broader patient population beyond controlled clinical se
What are the potential risks of participating in NCT06495541?
Common side effects may include diarrhea, fatigue, and skin reactions. Less common but serious side effects can occur, and it's important to report any new or worsening symptoms to your doctor immediately. The study will monitor for potential liver problems and heart issues. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06495541?
Ask your doctor about how Pyrotinib is given, potential side effects, and how it compares to other treatments. You will take Pyrotinib by mouth daily after breakfast and attend regular clinic visits for monitoring. Be prepared to share your medical history and cooperate with follow-up assessments. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06495541 signal from an investment perspective?
This study focuses on Pyrotinib, a targeted therapy for HER2-positive breast cancer, a significant market. Real-world data can support regulatory approval and market adoption. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves taking Pyrotinib daily and attending regular follow-up appointments. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.