Breast CancerNCT06495541
The Real World Study of Pyrotinib in the Treatment of Advanced Breast Cancer With HER2 Positive
A study testing Pyrotinib in people with Breast Cancer and RWS, run by Tianjin Medical University Cancer Institute and Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, RWS, Pyrotinib
- What is being tested?
- Pyrotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 30 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Research object：Planned to receive pyrrolidine for HER2 positive first-line breast cancer patients
Research purpose:
Read more
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:
- Evaluate the correlation between patient characteristics in the late stage of treatment and specific treatment plans and clinical outcomes Sex (including safety outcomes)
- Evaluate whether and how previous anti HER2 therapy affects the efficacy of subsequent pyrrolitinib treatment
- 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
Read the 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:
- 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.
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.
- Conditions
- Breast Cancer, RWS, Pyrotinib
- Being tested
- Pyrotinib
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PyrotinibDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Pyrotinib | Other | Not described Receives: Drug: Pyrotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
The time from randomization to disease progression evaluated by researchers for patients
Measured: 24.3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start1 Apr 2026 (estimated)
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06495541
- Sponsor's protocol ID
- Tianjin Cancer Hospital..
- Status last verified
- Feb 2026
- First submitted
- 3 Jul 2024
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Real World Study of Pyrotinib in the Treatment of Advanced Breast Cancer With HER2 Positive
- ClinicalTrials.gov ID
- NCT06495541
- Acronym / sponsor ID
- Tianjin Cancer Hospital..
- Conditions
- Breast Cancer, RWS, Pyrotinib
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 10 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Evaluate the correlation between patient characteristics in the late stage of treatment and specific treatment plans and clinical outcomes Sex (including safety outcomes)
- Evaluate whether and how previous anti HER2 therapy affects the efficacy of subsequent pyrrolitinib treatment
- 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:
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pyrotinib | Other | Drug: Pyrotinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PyrotinibAdministration 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. | Drug | Pyrotinib |
Primary outcome
PFS
Time frame: 24.3months
The time from randomization to disease progression evaluated by researchers for patients
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Pyrotinib in people with Breast Cancer and RWS, run by Tianjin Medical University Cancer Institute and Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact xuejing liu (19502151516, lxj8109@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 24.3months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.