Breast Cancer, HER2HER2 PATHNCT05203458
Prevalence and Clinicopathologic Features of Different HER2 Level in Chinese Breast Cancer Patients
An observational study of Breast Cancer, HER2, run by AstraZeneca at 7 sites in China.
Trial summary
This retrospective study aims to estimate the prevalence of different HER2 expression levels (HER2+, HER2-low, HER2 Ø) in approximately 200 breast cancer patients at FUSCC through the year of 2015 and 3000 breast cancer patients from about 10 medical centres in China between July 2021 and July 2022 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer, HER2
- How many people
- 3,136 participants
- Where
- 7 sitesChina
- Study dates
- 24 Feb 2022to 5 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Approximately 3000 eligible breast cancer patients from about 10 medical sites in China from July 2021 to July 2022 and 200 patients admitted at FUSCC from January 1st 2015 to December 31st 2015. Eligible patients will be those who had qualified archived HER2 IHC slides.
Who may be able to join
- Patients fulfilling all of the following criteria will be eligible for this study:
- Male and female patients must have a histological confirmed diagnosis of BC
- The patients must be ≥18 years old at the diagnosis.
- In PART 1, all patients should be diagnosed at FUSCC between Jan 2015 and Dec 2015.
- In PART 2, all patients should be diagnosed at all participating sites between July 2021 and July 2022.
- Provision of at least 1 archived HER2 IHC slides associated with confirmed diagnosis of BC, which are in good condition for rescoring.
- FISH result is available for HER2 IHC2+ in primary scoring.
Who cannot join
- Patients who meet any of the following criteria will be disqualified from entering the study:
- Absence of all demographic, histopathologic, clinicopathologic information .
- Have a history of other malignancies, other than basal cell carcinoma of the skin and squamous cell carcinoma of the skin.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Research Site
Guangzhou
Research Site
Jinan
Research Site
Shanghai, Shanhai
Research Site
Shenyang
Research Site
Wuhan
Research Site
Xi'an
Research Site
Zhengzhou
About this study
Official title: HER2 Retrospective Epidemiology Study Prevalence and Clinicopathologic Features of Different HER2 Level in Chinese Breast Cancer Patients (HER2 PATH)
This retrospective study aims to estimate the prevalence of different HER2 expression levels (HER2+, HER2-low, HER2 Ø) in approximately 200 breast cancer patients at FUSCC through the year of 2015 and 3000 breast cancer patients from about 10 medical centres in China between July 2021 and July 2022
Read the detailed description
This is a multicenter, retrospective study to estimate the prevalence of different HER2 expression levels (HER2+, HER2-low, HER2 Ø) in approximately 200 breast cancer patients at FUSCC through the year of 2015 and 3000 breast cancer patients from about 10 medical centres in China between July 2021 and July 2022.
This study will be divided into two parts： The first part will include 200 subjects who were pathologically diagnosed with breast cancer at FUSCC between Jan 2015 and Dec 2015 (PART 1).This part will collect rescored HER2 expression level results based on the archived HER2 IHC slides and re-staining and re-scoring HER-2 IHC while relative demographic, treatment, and clinicopathologic data will be extracted from the FUSCC Breast Cancer Single Disease Database.
The second part will include 3000 patients from all sites in China who were pathologically diagnosed with breast cancer between July 2021 and July 2022 (PART 2). This part will collect re-assessed HER2 expression level results based on the archived HER2 IHC slides. The general information of patients, diagnosis, clinicopathological information were collected from medical records, Hospital Information System (HIS) and Laboratory Information Management System (LIS).
In PART 2, among 3000 patients, 270 from all participating sites except FUSCC should have enough tumor tissue for re-staining and re-scoring HER-2 IHC at FUSCC to analyse the concordance between leading site and other centers.
In PART 2, among 3000 patients, 800 HER-2 IHC samples will be selected for the validation through AI-assisted HER2 assessment system
- Conditions
- Breast Cancer, HER2
- Keywords
- breast cancer,HER2
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
The Prevalence of different HER2 expression levels
To estimate the prevalence of different HER2 expression levels (HER2+, HER2-low(defined as IHC 1+,2+/ISH-), HER2 Ø) in Chinese breast cancer patients in PART 2.
Measured: Within one year
Secondary outcomes (16)
Tumor size of histopathological
Tumor size of Histopathological characteristic by different HER2 expression level (Ø /Low/High) in PART 1 and PART 2
Measured: Within one year
Positive lymph node number of the histopathological
Positive lymph node number of histopathological characteristic by different HER2 expression level (Ø /Low/High) in PART 1 and PART 2
Measured: Within one year
TNM stage by different HER2 expression levels
TNM stage by different HER2 expression level (Ø /Low/High) in PART 1 and PART 2
Measured: Within one year
Pathological type of histopathological
Pathological type by different HER2 expression level (Ø /Low/High) in PART 1 and PART 2
Measured: Within one year
Histological grade of histopathological
Histological grade by different HER2 expression level (Ø /Low/High) in PART 1 and PART 2
Measured: Within one year
Multi-focal of histopathological
Multi-focal by different HER2 expression level (Ø /Low/High) in PART 1 and PART 2
Measured: Within one year
ER status of histopathological
ER status by different HER2 expression level (Ø /Low/High) in PART 1 and PART 2
Measured: Within one year
ER percentage by different HER2 expression levels.
ER percentage by different HER2 expression level (Ø /Low/High) in PART 1 and PART 2
Measured: Within one year
PR status of histopathological
PR status by different HER2 expression level (Ø /Low/High) in PART 1 and PART 2
Measured: Within one year
PR percentage by different HER2 expression levels.
PR(Progesterone Receptor) percentage by different HER2 expression level (Ø /Low/High) in PART 1 and PART 2
Measured: Within one year
Ki-67 percentage by different HER2 expression levels.
Histopathological and clinicopathological characteristics by different HER2 expression level (Ø /Low/High) including: Ki-67 percentage,in PART 1 and PART 2
Measured: Within one year
HER2 IHC score of histopathological
HER2 IHC score by different HER2 expression level (Ø /Low/High) in PART 1 and PART 2
Measured: Within one year
FISH status of histopathological
FISH status by different HER2 expression level (Ø /Low/High) in PART 1 and PART 2
Measured: Within one year
The concordance between historical scoring and reassess scoring in each IHC score category (IHC score Ø, 1+, 2+and 3+)
To estimate the concordance between historical scoring and reassess scoring in each IHC score category (IHC score Ø, 1+, 2+and 3+) in PART 2
Measured: Within one year
The concordance of HER2 expression between manual and AI assisted HER2 interpretation
To estimate the concordance of HER2 expression between manual and AI assisted HER2 interpretation among 800 patients in PART 2
Measured: Within one year
The concordance of HER2 expression between leading site (FUSCC) and other centers
To estimate the concordance of HER2 expression between leading site (FUSCC) and other centers among 270 patients in PART 2
Measured: Within one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start24 Feb 2022
- Primary completion5 Jul 2023
- Study completion5 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer, HER2Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,136 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wentao Yang, Dr., Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05203458
- Sponsor's protocol ID
- D9673R00011
- Acronym
- HER2 PATH
- Status last verified
- May 2024
- First submitted
- 20 Oct 2021
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lv H, Yue J, Zhang Q, Xu F, Gao P, Yang H, Nie X, Kong L, Zhang G, Li J, Xiao S, Wu H, Xing A, Hong M, Fan J, Guan H, Cao P, Ni H, Yang W. Prevalence and concordance of HER2-low and HER2-ultralow status between historical and rescored results in a multicentre study of breast cancer patients in China. Breast Cancer Res. 2025 Mar 25;27(1):45. doi: 10.1186/s13058-025-02001-0.
PubMed 40134013
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HER2 Retrospective Epidemiology Study Prevalence and Clinicopathologic Features of Different HER2 Level in Chinese Breast Cancer Patients (HER2 PATH)
- ClinicalTrials.gov ID
- NCT05203458
- Acronym / sponsor ID
- HER2 PATH / D9673R00011
- Conditions
- Breast Cancer, HER2
- Keywords
- breast cancer,HER2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,136 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 24 Feb 2022 (actual)
- Primary completion
- 5 Jul 2023 (actual)
- Study completion
- 5 Jul 2023 (actual)
- First posted
- 24 Jan 2022 (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.
This retrospective study aims to estimate the prevalence of different HER2 expression levels (HER2+, HER2-low, HER2 Ø) in approximately 200 breast cancer patients at FUSCC through the year of 2015 and 3000 breast cancer patients from about 10 medical centres in China between July 2021 and July 2022
Detailed description
This is a multicenter, retrospective study to estimate the prevalence of different HER2 expression levels (HER2+, HER2-low, HER2 Ø) in approximately 200 breast cancer patients at FUSCC through the year of 2015 and 3000 breast cancer patients from about 10 medical centres in China between July 2021 and July 2022.
This study will be divided into two parts： The first part will include 200 subjects who were pathologically diagnosed with breast cancer at FUSCC between Jan 2015 and Dec 2015 (PART 1).This part will collect rescored HER2 expression level results based on the archived HER2 IHC slides and re-staining and re-scoring HER-2 IHC while relative demographic, treatment, and clinicopathologic data will be extracted from the FUSCC Breast Cancer Single Disease Database.
The second part will include 3000 patients from all sites in China who were pathologically diagnosed with breast cancer between July 2021 and July 2022 (PART 2). This part will collect re-assessed HER2 expression level results based on the archived HER2 IHC slides. The general information of patients, diagnosis, clinicopathological information were collected from medical records, Hospital Information System (HIS) and Laboratory Information Management System (LIS).
In PART 2, among 3000 patients, 270 from all participating sites except FUSCC should have enough tumor tissue for re-staining and re-scoring HER-2 IHC at FUSCC to analyse the concordance between leading site and other centers.
In PART 2, among 3000 patients, 800 HER-2 IHC samples will be selected for the validation through AI-assisted HER2 assessment system
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Approximately 3000 eligible breast cancer patients from about 10 medical sites in China from July 2021 to July 2022 and 200 patients admitted at FUSCC from January 1st 2015 to December 31st 2015. Eligible patients will be those who had qualified archived HER2 IHC slides.
Key inclusion criteria (7 listed)
- Male and female patients must have a histological confirmed diagnosis of BC
- The patients must be ≥18 years old at the diagnosis.
- In PART 1, all patients should be diagnosed at FUSCC between Jan 2015 and Dec 2015.
- In PART 2, all patients should be diagnosed at all participating sites between July 2021 and July 2022.
- Provision of at least 1 archived HER2 IHC slides associated with confirmed diagnosis of BC, which are in good condition for rescoring.
Key exclusion criteria (3 listed)
- Patients who meet any of the following criteria will be disqualified from entering the study:
- Absence of all demographic, histopathologic, clinicopathologic information .
- Have a history of other malignancies, other than basal cell carcinoma of the skin and squamous cell carcinoma of the skin.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Prevalence of different HER2 expression levels
Time frame: Within one year
To estimate the prevalence of different HER2 expression levels (HER2+, HER2-low(defined as IHC 1+,2+/ISH-), HER2 Ø) in Chinese breast cancer patients in PART 2.
16 secondary outcomes
Tumor size of histopathological
Time frame: Within one year
Positive lymph node number of the histopathological
Time frame: Within one year
TNM stage by different HER2 expression levels
Time frame: Within one year
Pathological type of histopathological
Time frame: Within one year
Histological grade of histopathological
Time frame: Within one year
Multi-focal of histopathological
Time frame: Within one year
ER status of histopathological
Time frame: Within one year
ER percentage by different HER2 expression levels.
Time frame: Within one year
PR status of histopathological
Time frame: Within one year
PR percentage by different HER2 expression levels.
Time frame: Within one year
Ki-67 percentage by different HER2 expression levels.
Time frame: Within one year
HER2 IHC score of histopathological
Time frame: Within one year
FISH status of histopathological
Time frame: Within one year
The concordance between historical scoring and reassess scoring in each IHC score category (IHC score Ø, 1+, 2+and 3+)
Time frame: Within one year
The concordance of HER2 expression between manual and AI assisted HER2 interpretation
Time frame: Within one year
The concordance of HER2 expression between leading site (FUSCC) and other centers
Time frame: Within one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Derived from this study: PubMed 40134013Lv H, Yue J, Zhang Q, Xu F, Gao P, Yang H, Nie X, Kong L, Zhang G, Li J, Xiao S, Wu H, Xing A, Hong M, Fan J, Guan H, Cao P, Ni H, Yang W. Prevalence and concordance of HER2-low and HER2-ultralow status between historical and rescored results in a multicentre study of breast cancer patients in China. Breast Cancer Res. 2025 Mar 25;27(1):45. doi: 10.1186/s13058-025-02001-0.
- redacted CSR SynopsisLink provided by the sponsor.
- 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.
Wentao Yang, Dr. principal investigator
Fudan University
7 sites 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, HER2, run by AstraZeneca at 7 sites 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 7 inclusion and 3 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: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The Prevalence of different HER2 expression levels (time frame: Within one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05203458, which also lists 1 linked publication.
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 16 May 2024.