Pan-tumor(NSCLC, GYN Cancers, BTC and UC)Pan HER2NCT07404202
A Multicenter, Non-interventional, Descriptive Study to Assess Assay Concordance of HER2 IHC Testing in Chinese Pan-tumor Patients
An observational study of Pan-tumor(NSCLC, GYN Cancers, BTC and UC), run by AstraZeneca at 14 sites in China.
Trial summary
This is a multicenter, non-interventional, descriptive study to retrospectively collect solid tumor samples from focused tumor types (NSCLC, GYN cancers, BTC and UC) and assess both assay concordance and interpretation concordance. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pan-tumor(NSCLC, GYN Cancers, BTC and UC)
- How many people
- 2,100 participants
- Where
- 14 sitesChina
- Study dates
- 6 Mar 2026to 31 Dec 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Male and female patients must have a histological confirmed diagnosis of NSCLC, BTC, GYN cancers, or UC between Jan 01, 2023 and Sep 30, 2025.
Who may be able to join
- Patients must be at least 18 years of age
- Male and female patients must have a histological confirmed diagnosis of NSCLC, BTC, GYN cancers, or UC between Jan 01, 2023 and Sep 30, 2025.
- For GYN cancers, only cervical cancer, endometrial cancer and ovarian cancer should be included. For each gynecological cancer listed above, at least 5 cases need to be enrolled at each expression level (i.e., IHC 0/1+/2+/3+).
- Patients must have sufficient archived tumor tissue available, with at least 15 slides suitable for HER2 status determination. Both resection or biopsy samples are acceptable. The age limit of archived tissue blocks is 5 years.
Who cannot join
- Have a history of other cancers besides NSCLC, BTC, GYN cancers and UC.
- Specimens of patients that may affect interpretation evaluated by the researcher (e.g., frozen specimens, decalcified specimens, specimens with limited tumor content, etc.)
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
14 sites in 1 country
China14 sites, 10 recruiting
- Recruiting
Research Site
Beijing
- Withdrawn
Research Site
Changsha
- Recruiting
Research Site
Chengdu
- Recruiting
Research Site
Guangzhou
- Withdrawn
Research Site
Guangzhou
- Recruiting
Research Site
Haerbin
- Recruiting
Research Site
Jinan
- Recruiting
Research Site
Nantong
- Withdrawn
Research Site
Shanghai
- Recruiting
Research Site
Shanghai
- Recruiting
Research Site
Shenyang
- Withdrawn
Research Site
Suzhou
- Recruiting
Research Site
Ürümqi
- Recruiting
Research Site
Zhejiang
About this study
Official title: Pan HER2: A Multicenter, Non-interventional, Descriptive Study to Assess Assay Concordance of HER2 IHC Testing in Chinese Pan-tumor Patients
This is a multicenter, non-interventional, descriptive study to retrospectively collect solid tumor samples from focused tumor types (NSCLC, GYN cancers, BTC and UC) and assess both assay concordance and interpretation concordance.
Read the detailed description
This is a multicenter, non-interventional, descriptive study which included about 2100 patients, a mixture of NSCLC, BTC, GYN cancers and UC, from 12 sites with confirmed diagnosis between 2023 Jan and 2025 Sep. This study includes two phases, which are enrollment phase and assessment phase.
In the enrollment phase, all sites will retrospectively collect about 2100 patients (NSCLC ~1,000; BTC ~500; GYN ~450; and UC ~150). Every patient will be tested for HER2 status by 4B5 in local labs. All HER2 results will be reviewed and aligned by a committee of three pathologists using GC algorithms. Based on HER2 results by HercepTest at central lab, patient will be selected for further evaluation in assessment phase.
In assessment phase, a total of 320 patients will be included and selected from enrollment phase to meet sample size requirement which is 80 patients with different HER2 expression level (each 20 cases for IHC 0/1+/2+/3+) in NSCLC, BTC, GYN cancers and UC cohorts.
In Part I Assay performance evaluation, tissue sample of every patient will be sectioned at least 15 slides and send to central labs for assays evaluation. Interpretation results will be reviewed and aligned by a committee of three pathologists using GC algorithms. Assays and performed platform details are listed below: Roche 4B5 in Ventana platform, MXB\Zhongshan\An Biping\Amoy in Ventana (or Leica) platform (5 assays) v.s. HercepTest in Dako platform.
Part II Interpretation concordance evaluation: inter-obsever agreement will be evaluated based on scanned images. Specifically, the first 40 slides (each 10 for 0/1+/2+/3+, each 10 for four disease cohorts) will be selected and digitalized. 36 pathologists, 3 from each site, will be trained for GC interpretation algorithm before joining in the assessment. All slides will be interpreted by all pathologists.
- Keywords
- Pan-tumor(NSCLC, GYN cancers, BTC and UC), HER2 assay concordance and interpretation concordance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NSCLC | Approximately 1,000 non-small cell lung cancer samples are expected to be collected, and 80 patients will be selected to evaluate assay concordance on confusion matrix results between 5 assays and HercepTest. | |
| BTC | Approximately 500 biliary tract cancer samples are expected to be collected,and 80 patients will be selected to evaluate assay concordance on confusion matrix results between 5 assays and HercepTest. | |
| GYN | Approximately 450 gynecological cancer samples are expected to be collected, and 80 patients will be selected to evaluate assay concordance on confusion matrix results between 5 assays and HercepTest. | |
| UC | Approximately 150 urothelial carcinoma samples are expected to be collected,and 80 patients will be selected to evaluate assay concordance on confusion matrix results between 5 assays and HercepTest. |
What is being measured
The primary outcome is the main question the study is designed to answer.
NPA of HER2 IHC 3+ based on confusion matrix results betwee other assays(Roche 4B5\MXB\Zhongshan\An Biping\Amoy) and HercepTest
To assess the NPA of HER2 IHC 3+ based on confusion matrix results between other assays(Roche 4B5\MXB\Zhongshan\An Biping\Amoy) and HercepTest
Measured: From the assessment phase start to the final slides interpreted，up to approximately 6 month
PPA of HER2 IHC 3+ based on confusion matrix results between other assays(Roche 4B5\MXB\Zhongshan\An Biping\Amoy) and HercepTest
To assess the PPA of HER2 IHC 3+ based on confusion matrix results between other assays (Roche 4B5\MXB\Zhongshan\An Biping\Amoy) and HercepTest
Measured: From the assessment phase start to the final slides interpreted，up to approximately 6 month
Secondary outcomes (13)
Inter-observer concordance in binary HER2 negative (IHC 0/1+/2+) and positive status (IHC3+);
To assess the Inter-observer concordance in binary HER2 negative (IHC 0/1+/2+) and positive status (IHC3+);
Measured: From first slides interpreted to Interpretation concordance evaluation end，up to approximately 6 month
Inter-observer concordance in binary HER2 (IHC 0/1+) v.s. HER2 (IHC 2+/3+);
To assess the Inter-observer concordance in binary HER2 (IHC 0/1+) v.s. HER2 (IHC 2+/3+);
Measured: From first slides interpreted to Interpretation concordance evaluation end，up to approximately 6 month
Inter-observer concordance in four category HER2 IHC 3+ vs. IHC 2+ vs. IHC 1+ vs. IHC 0
To assess the Inter-observer concordance in four category HER2 IHC 3+ vs. IHC 2+ vs. IHC 1+ vs. IHC 0
Measured: From first slides interpreted to Interpretation concordance evaluation end，up to approximately 6 month
OPA of HER2 IHC 3+ based on confusion matrix results between other assays and HercepTest
To assess the OPA of HER2 IHC 3+ based on confusion matrix results between other assays and HercepTest
Measured: From the assessment phase start to the final slides interpreted，up to approximately 6 month
Cohen's kappa of HER2 IHC 3+ based on confusion matrix results between other assays and HercepTest
To assess the Cohen's kappa of HER2 IHC 3+ based on confusion matrix results between other assays and HercepTest
Measured: From the assessment phase start to the final slides interpreted，up to approximately 6 month
NPA of binary HER2 (IHC 0/1+) v.s. HER2 (IHC 2+/3+), and four category HER2 IHC 3+ vs. IHC 2+ vs. IHC 1+ vs. IHC 0 based on confusion matrix results between other assay and HercepTest, overall and by disease cohort
To assess the NPA of binary HER2 (IHC 0/1+) v.s. HER2 (IHC 2+/3+), and four category HER2 IHC 3+ vs. IHC 2+ vs. IHC 1+ vs. IHC 0 based on confusion matrix results between other assay and HercepTest, overall and by disease cohort
Measured: From the assessment phase start to the final slides interpreted，up to approximately 6 month
PPA of binary HER2 (IHC 0/1+) v.s. HER2 (IHC 2+/3+), and four category HER2 IHC 3+ vs. IHC 2+ vs. IHC 1+ vs. IHC 0 based on confusion matrix results between other assay and HercepTest, overall and by disease cohort
To assess the PPA of binary HER2 (IHC 0/1+) v.s. HER2 (IHC 2+/3+), and four category HER2 IHC 3+ vs. IHC 2+ vs. IHC 1+ vs. IHC 0 based on confusion matrix results between other assay and HercepTest, overall and by disease cohort
Measured: From the assessment phase start to the final slides interpreted，up to approximately 6 month
OPA of binary HER2 (IHC 0/1+) v.s. HER2 (IHC 2+/3+), and four category HER2 IHC 3+ vs. IHC 2+ vs. IHC 1+ vs. IHC 0 based on confusion matrix results between other assay and HercepTest, overall and by disease cohort
To assess the OPA of binary HER2 (IHC 0/1+) v.s. HER2 (IHC 2+/3+), and four category HER2 IHC 3+ vs. IHC 2+ vs. IHC 1+ vs. IHC 0 based on confusion matrix results between other assay and HercepTest, overall and by disease cohort
Measured: From the assessment phase start to the final slides interpreted，up to approximately 6 month
Cohen's kappa of binary HER2 (IHC 0/1+) v.s. HER2 (IHC 2+/3+), and four category HER2 IHC 3+ vs. IHC 2+ vs. IHC 1+ vs. IHC 0 based on confusion matrix results between other assay and HercepTest, overall and by disease cohort
To assess the Cohen's kappa of binary HER2 (IHC 0/1+) v.s. HER2 (IHC 2+/3+), and four category HER2 IHC 3+ vs. IHC 2+ vs. IHC 1+ vs. IHC 0 based on confusion matrix results between other assay and HercepTest, overall and by disease cohort
Measured: From the assessment phase start to the final slides interpreted，up to approximately 6 month
NPA of HER2 IHC 2+/3+ (IHC 1+ in GYN cancers) based on confusion matrix results between other assay and HercepTest, overall and by disease cohort
To assess the NPA of HER2 IHC 2+/3+ (IHC 1+ in GYN cancers) based on confusion matrix results between other assay and HercepTest, overall and by disease cohort
Measured: From the assessment phase start to the final slides interpreted，up to approximately 6 month
PPA of HER2 IHC 2+/3+ (IHC 1+ in GYN cancers) based on confusion matrix results between other assay and HercepTest, overall and by disease cohort
To assess the PPA of HER2 IHC 2+/3+ (IHC 1+ in GYN cancers) based on confusion matrix results between other assay and HercepTest, overall and by disease cohort
Measured: From the assessment phase start to the final slides interpreted，up to approximately 6 month
OPA of HER2 IHC 2+/3+ (IHC 1+ in GYN cancers) based on confusion matrix results between other assay and HercepTest, overall and by disease cohort
To assess the OPA of HER2 IHC 2+/3+ (IHC 1+ in GYN cancers) based on confusion matrix results between other assay and HercepTest, overall and by disease cohort
Measured: From the assessment phase start to the final slides interpreted，up to approximately 6 month
Cohen's kappa of HER2 IHC 2+/3+ (IHC 1+ in GYN cancers) based on confusion matrix results between other assay and HercepTest, overall and by disease cohort
To assess the Cohen's kappa of HER2 IHC 2+/3+ (IHC 1+ in GYN cancers) based on confusion matrix results between other assay and HercepTest, overall and by disease cohort
Measured: From the assessment phase start to the final slides interpreted，up to approximately 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start6 Mar 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pan-tumor(NSCLC, GYN Cancers, BTC and UC)Studies 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
- 2,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07404202
- Sponsor's protocol ID
- D9673L00020
- Acronym
- Pan HER2
- Status last verified
- Sep 2026
- First submitted
- 5 Feb 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient- level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes,indicates that AZ are accepting requests for IPD,but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pan HER2: A Multicenter, Non-interventional, Descriptive Study to Assess Assay Concordance of HER2 IHC Testing in Chinese Pan-tumor Patients
- ClinicalTrials.gov ID
- NCT07404202
- Acronym / sponsor ID
- Pan HER2 / D9673L00020
- Keywords
- Pan-tumor(NSCLC, GYN cancers, BTC and UC), HER2 assay concordance and interpretation concordance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,100 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 6 Mar 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Feb 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.
This is a multicenter, non-interventional, descriptive study to retrospectively collect solid tumor samples from focused tumor types (NSCLC, GYN cancers, BTC and UC) and assess both assay concordance and interpretation concordance.
Detailed description
This is a multicenter, non-interventional, descriptive study which included about 2100 patients, a mixture of NSCLC, BTC, GYN cancers and UC, from 12 sites with confirmed diagnosis between 2023 Jan and 2025 Sep. This study includes two phases, which are enrollment phase and assessment phase.
In the enrollment phase, all sites will retrospectively collect about 2100 patients (NSCLC ~1,000; BTC ~500; GYN ~450; and UC ~150). Every patient will be tested for HER2 status by 4B5 in local labs. All HER2 results will be reviewed and aligned by a committee of three pathologists using GC algorithms. Based on HER2 results by HercepTest at central lab, patient will be selected for further evaluation in assessment phase.
In assessment phase, a total of 320 patients will be included and selected from enrollment phase to meet sample size requirement which is 80 patients with different HER2 expression level (each 20 cases for IHC 0/1+/2+/3+) in NSCLC, BTC, GYN cancers and UC cohorts.
In Part I Assay performance evaluation, tissue sample of every patient will be sectioned at least 15 slides and send to central labs for assays evaluation. Interpretation results will be reviewed and aligned by a committee of three pathologists using GC algorithms. Assays and performed platform details are listed below: Roche 4B5 in Ventana platform, MXB\Zhongshan\An Biping\Amoy in Ventana (or Leica) platform (5 assays) v.s. HercepTest in Dako platform.
Part II Interpretation concordance evaluation: inter-obsever agreement will be evaluated based on scanned images. Specifically, the first 40 slides (each 10 for 0/1+/2+/3+, each 10 for four disease cohorts) will be selected and digitalized. 36 pathologists, 3 from each site, will be trained for GC interpretation algorithm before joining in the assessment. All slides will be interpreted by all pathologists.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NSCLC | – | –Approximately 1,000 non-small cell lung cancer samples are expected to be collected, and 80 patients will be selected to evaluate assay concordance on confusion matrix results between 5 assays and HercepTest. |
| BTC | – | –Approximately 500 biliary tract cancer samples are expected to be collected,and 80 patients will be selected to evaluate assay concordance on confusion matrix results between 5 assays and HercepTest. |
| GYN | – | –Approximately 450 gynecological cancer samples are expected to be collected, and 80 patients will be selected to evaluate assay concordance on confusion matrix results between 5 assays and HercepTest. |
| UC | – | –Approximately 150 urothelial carcinoma samples are expected to be collected,and 80 patients will be selected to evaluate assay concordance on confusion matrix results between 5 assays and HercepTest. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Male and female patients must have a histological confirmed diagnosis of NSCLC, BTC, GYN cancers, or UC between Jan 01, 2023 and Sep 30, 2025.
Key inclusion criteria (4 listed)
- Patients must be at least 18 years of age
- Male and female patients must have a histological confirmed diagnosis of NSCLC, BTC, GYN cancers, or UC between Jan 01, 2023 and Sep 30, 2025.
- Patients must have sufficient archived tumor tissue available, with at least 15 slides suitable for HER2 status determination. Both resection or biopsy samples are acceptable. The age limit of archived tissue blocks is 5 years.
Key exclusion criteria (2 listed)
- Have a history of other cancers besides NSCLC, BTC, GYN cancers and UC.
- Specimens of patients that may affect interpretation evaluated by the researcher (e.g., frozen specimens, decalcified specimens, specimens with limited tumor content, etc.)
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
NPA of HER2 IHC 3+ based on confusion matrix results betwee other assays(Roche 4B5\MXB\Zhongshan\An Biping\Amoy) and HercepTest
Time frame: From the assessment phase start to the final slides interpreted，up to approximately 6 month
To assess the NPA of HER2 IHC 3+ based on confusion matrix results between other assays(Roche 4B5\MXB\Zhongshan\An Biping\Amoy) and HercepTest
PPA of HER2 IHC 3+ based on confusion matrix results between other assays(Roche 4B5\MXB\Zhongshan\An Biping\Amoy) and HercepTest
Time frame: From the assessment phase start to the final slides interpreted，up to approximately 6 month
To assess the PPA of HER2 IHC 3+ based on confusion matrix results between other assays (Roche 4B5\MXB\Zhongshan\An Biping\Amoy) and HercepTest
13 secondary outcomes
Inter-observer concordance in binary HER2 negative (IHC 0/1+/2+) and positive status (IHC3+);
Time frame: From first slides interpreted to Interpretation concordance evaluation end，up to approximately 6 month
Inter-observer concordance in binary HER2 (IHC 0/1+) v.s. HER2 (IHC 2+/3+);
Time frame: From first slides interpreted to Interpretation concordance evaluation end，up to approximately 6 month
Inter-observer concordance in four category HER2 IHC 3+ vs. IHC 2+ vs. IHC 1+ vs. IHC 0
Time frame: From first slides interpreted to Interpretation concordance evaluation end，up to approximately 6 month
OPA of HER2 IHC 3+ based on confusion matrix results between other assays and HercepTest
Time frame: From the assessment phase start to the final slides interpreted，up to approximately 6 month
Cohen's kappa of HER2 IHC 3+ based on confusion matrix results between other assays and HercepTest
Time frame: From the assessment phase start to the final slides interpreted，up to approximately 6 month
NPA of binary HER2 (IHC 0/1+) v.s. HER2 (IHC 2+/3+), and four category HER2 IHC 3+ vs. IHC 2+ vs. IHC 1+ vs. IHC 0 based on confusion matrix results between other assay and HercepTest, overall and by disease cohort
Time frame: From the assessment phase start to the final slides interpreted，up to approximately 6 month
PPA of binary HER2 (IHC 0/1+) v.s. HER2 (IHC 2+/3+), and four category HER2 IHC 3+ vs. IHC 2+ vs. IHC 1+ vs. IHC 0 based on confusion matrix results between other assay and HercepTest, overall and by disease cohort
Time frame: From the assessment phase start to the final slides interpreted，up to approximately 6 month
OPA of binary HER2 (IHC 0/1+) v.s. HER2 (IHC 2+/3+), and four category HER2 IHC 3+ vs. IHC 2+ vs. IHC 1+ vs. IHC 0 based on confusion matrix results between other assay and HercepTest, overall and by disease cohort
Time frame: From the assessment phase start to the final slides interpreted，up to approximately 6 month
Cohen's kappa of binary HER2 (IHC 0/1+) v.s. HER2 (IHC 2+/3+), and four category HER2 IHC 3+ vs. IHC 2+ vs. IHC 1+ vs. IHC 0 based on confusion matrix results between other assay and HercepTest, overall and by disease cohort
Time frame: From the assessment phase start to the final slides interpreted，up to approximately 6 month
NPA of HER2 IHC 2+/3+ (IHC 1+ in GYN cancers) based on confusion matrix results between other assay and HercepTest, overall and by disease cohort
Time frame: From the assessment phase start to the final slides interpreted，up to approximately 6 month
PPA of HER2 IHC 2+/3+ (IHC 1+ in GYN cancers) based on confusion matrix results between other assay and HercepTest, overall and by disease cohort
Time frame: From the assessment phase start to the final slides interpreted，up to approximately 6 month
OPA of HER2 IHC 2+/3+ (IHC 1+ in GYN cancers) based on confusion matrix results between other assay and HercepTest, overall and by disease cohort
Time frame: From the assessment phase start to the final slides interpreted，up to approximately 6 month
Cohen's kappa of HER2 IHC 2+/3+ (IHC 1+ in GYN cancers) based on confusion matrix results between other assay and HercepTest, overall and by disease cohort
Time frame: From the assessment phase start to the final slides interpreted，up to approximately 6 month
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 24 Sep 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient- level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes,indicates that AZ are accepting requests for IPD,but this does not mean all requests will be shared.
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.
AstraZeneca Clinical Study Information Center contact
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pan-tumor(NSCLC, GYN Cancers, BTC and UC), run by AstraZeneca at 14 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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 24 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 14 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?
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 AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NPA of HER2 IHC 3+ based on confusion matrix results betwee other assays(Roche 4B5\MXB\Zhongshan\An Biping\Amoy) and HercepTest (time frame: From the assessment phase start to the final slides interpreted，up to approximately 6 month). The study lists 2 primary outcomes in all. 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 24 Sep 2026.