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Active, not recruitingNCT07810634Updated Sep 9, 2026

Pyrotinib for HER2-Positive Advanced Breast Cancer Previously Treated With Trastuzumab and Pertuzumab

An observational study in Breast Cancer, sponsored by Beijing 302 Hospital. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by Beijing 302 Hospital · Observational

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Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 1,928 studies in Breast Neoplasms with a site in China — 866 open to participants now, 1,064 under way, 210 of them phase 3. Breast Neoplasms · China.

Planned enrollment
213th of 407
200 · median 240
Started
2026
with 184 others
Observational
407 of 1,928
177 open now
Primary completion
2026-12
later than 515 of 1,063 live
Registered
1,896th of 1,928
by date

Among the 1,928 studies in Breast Neoplasms with a site in China, this one is the 213th largest by planned enrollment of the 407 observational ones that give a count, is one of 185 that started in 2026, is one of 407 observational ones, reaches primary completion later than 515 of the 1,063 other live ones, and was the 1,896th registered.

Breast Neoplasms

14,832 studies on the registry are indexed under Breast Neoplasms; 3,320 are open to participants now.

Browse Breast Neoplasms studies →

Open to participants now

866 of the 1,928 studies in Breast Neoplasms with a site in China are open now. Recruiting first, the newest first:

861 more — sign in →

All 866 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 2,399 Breast Neoplasms studies recruiting now, 1,570 (65%) set no upper age limit and 592 (25%) stop at 75 or younger; 103 take children under 18; 215 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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 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.

03

Conditions studied

  • Breast Cancer

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04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 1. Diagnosis of unresectable locally advanced or breast cancer 2. Confirmed -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. > 3 months 6. ≤3

Exclusion criteria

Exclusion Criteria:

  • 1. Incomplete clinical case data
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

HER2

HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.

In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • Pyrotinib

    Pyrotinib-treated patients with prior trastuzumab and pertuzumab exposure

    Drug: Pyrotinib 400mg

Interventions

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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

    Time frame: 1year

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2026 (actual). Primary completion is estimated for Dec 2026, 3 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 3, 2026
First posted
Sep 9, 2026
StartActual
Sep 2, 2026
Primary completionEst.
Dec 30, 2026
CompletionEst.
Mar 30, 2027
Last update
Sep 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07810634
Lead sponsor
Beijing 302 Hospital
Responsible party
Sponsor
First posted
Sep 9, 2026
Start date
Sep 2, 2026
Primary completion
Dec 30, 2026 (estimated)
Completion
Mar 30, 2027 (estimated)
Last update
Sep 9, 2026

Study contacts

Tao Wang
study director · Beijing 302 Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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