Breast CancerNCT07810634
Pyrotinib for HER2-Positive Advanced Breast Cancer Previously Treated With Trastuzumab and Pertuzumab
An observational study of Breast Cancer, run by Beijing 302 Hospital at 1 site in China.
Trial summary
In China, pyrotinib is used for patients with HER2-positive advanced breast cancer who have progressed on trastuzumab. As anti-HER2 antibody therapy has advanced from trastuzumab monotherapy to trastuzumab-pertuzumab dual-target treatment, few clinical studies have investigated pyrotinib's efficacy among patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Pyrotinib 400mg
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 2 Sep 2026to 30 Mar 2027
- Phase
- Observational
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with HER2-positive advanced breast cancer who had previously been treated with either trastuzumab or pertuzumab, and who subsequently received pyrotinib-based therapy
Who may be able to join
- 1. Diagnosis of unresectable locally advanced or metastatic breast cancer 2. Confirmed HER2-positive status, defined as immunohistochemistry (IHC) 3+ or IHC 2+ with positive in situ hybridization (ISH) results 3. Prior systemic treatment of trastuzumab and pertuzumab 4. Adequate baseline cardiac, bone marrow, renal, hepatic, and blood coagulation functions 5. Life expectancy > 3 months 6. ECOG ≤3
Who cannot join
- 1. Incomplete clinical case data
Trial locations and contacts
1 site in 1 country.
China1 site
The Fifth Medical Center of the PLA General Hospital
Beijing, Beijing Municipality, 100071
About this study
Official title: Retrospective Analysis of Pyrotinib in the Treatment of HER2-Positive Advanced Breast Cancer Previously Treated With Trastuzumab and Pertuzumab
In China, pyrotinib is used for patients with HER2-positive advanced breast cancer who have progressed on trastuzumab. As anti-HER2 antibody therapy has advanced from trastuzumab monotherapy to trastuzumab-pertuzumab dual-target treatment, few clinical studies have investigated pyrotinib's efficacy among patients pre-treated with this dual-antibody regimen. This is a retrospective observational cohort study, which aims to assess the efficacy and safety of pyrotinib in this patient cohort.
- Conditions
- Breast Cancer
- Being tested
- Pyrotinib 400mg
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pyrotinib 400mgDrug
Pyrotinib (400 mg daily)-based treatment
| Study group | Role | What they receive |
|---|---|---|
| Pyrotinib | Pyrotinib-treated patients with prior trastuzumab and pertuzumab exposure Receives: Drug: Pyrotinib 400mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival(PFS)
PFS was defined as the time from the start of treatment to either the first documented disease progression or death from any cause
Measured: 4 years
Secondary outcomes (1)
Objective response rate (ORR)
ORR was defined as the proportion of patients with a complete response or a partial response
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start2 Sep 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Mar 2027 (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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing 302 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tao Wang, Study director, Beijing 302 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07810634
- Sponsor's protocol ID
- PYROTINIB-HER2 POSITIVE BREAST
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of Pyrotinib in the Treatment of HER2-Positive Advanced Breast Cancer Previously Treated With Trastuzumab and Pertuzumab
- ClinicalTrials.gov ID
- NCT07810634
- Acronym / sponsor ID
- PYROTINIB-HER2 POSITIVE BREAST
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Beijing 302 HospitalUniversity, hospital or other
- Study start
- 2 Sep 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 9 Sep 2026 (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.
In China, pyrotinib is used for patients with HER2-positive advanced breast cancer who have progressed on trastuzumab. As anti-HER2 antibody therapy has advanced from trastuzumab monotherapy to trastuzumab-pertuzumab dual-target treatment, few clinical studies have investigated pyrotinib's efficacy among patients pre-treated with this dual-antibody regimen. This is a retrospective observational cohort study, which aims to assess the efficacy and safety of pyrotinib in this patient cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pyrotinib | – | Drug: Pyrotinib 400mgPyrotinib-treated patients with prior trastuzumab and pertuzumab exposure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with HER2-positive advanced breast cancer who had previously been treated with either trastuzumab or pertuzumab, and who subsequently received pyrotinib-based therapy
Key inclusion criteria (1 listed)
- 1. Diagnosis of unresectable locally advanced or metastatic breast cancer 2. Confirmed HER2-positive status, defined as immunohistochemistry (IHC) 3+ or IHC 2+ with positive in situ hybridization (ISH) results 3. Prior systemic treatment of trastuzumab and pertuzumab 4. Adequate baseline cardiac, bone marrow, renal, hepatic, and blood coagulation functions 5. Life expectancy > 3 months 6. ECOG ≤3
Key exclusion criteria (1 listed)
- 1. Incomplete clinical case data
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 |
|---|---|---|
| Pyrotinib 400mgPyrotinib (400 mg daily)-based treatment | Drug | Pyrotinib |
Primary outcome
Progression free survival(PFS)
Time frame: 4 years
PFS was defined as the time from the start of treatment to either the first documented disease progression or death from any cause
1 secondary outcome
Objective response rate (ORR)
Time frame: 1year
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 9 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Tao Wang study director
Beijing 302 Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Beijing 302 Hospital at 1 site in China.
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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival(PFS) (time frame: 4 years). 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 9 Sep 2026.