Breast CancerVERITASNCT07743944
A Real-world Study Observing Treatment Patterns and Clinical Results for Patients in China With Hormone Receptor-positive, HER2-negative Metastatic Breast Cancer.
An observational study of Breast Cancer, run by AstraZeneca at 1 site in China.
Trial summary
The study aims to describe demographics, clinical characteristics, genetic test diagnosis, treatment patterns, and clinical outcomes in HR+/HER2- (including HER2-low, HER2-ultralow, and HER2-null) unresectable or metastatic breast cancer patients in China; and exploratory describe clinical outcomes by treatment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 5 Aug 2026to 4 Aug 2031
- 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: The study population includes Chinese adult patients with HR+/HER2- (including HER2-low, HER2-ultralow, and HER2-null) unresectable or metastatic breast cancer who are about to initiate 2L systemic therapy or initiated 2L systemic therapy within 2 months at participating sites.
Inclusion Criteria * Must be competent and able to comprehend, sign, and date an Institutional Review Board or Institutional Ethics Committee approved Informed consent form (ICF) before participating in the study. OR Eligible for exemption from informed consent (for patients who die or became lost to follow-up within 2 months of initiating 2L therapy). * Chinese men or women ≥ 18 years old at time of consent. * Pathologically documented breast cancer that: a) is unresectable or metastatic. b) is HR+/HER2- (IHC 2+/ISH- or IHC 1+ or IHC 0, with/without membrane staining) based on the most recent test result * Planning to initiate 2L treatment or initiated 2L systemic therapy within 2 months prior enrollment as per the prescription or medical records. Exclusion Criteria * Patients who plan to participate in any blinded interventional clinical trial in 2L setting.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Astra Zeneca Clinical Study Information Center contact
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital)
Nanjing, Jiangsu, 210029
About this study
Official title: VERITAS Longitudinal Real-world Registry of HR+/HER2- mBC to Understand Treatment Pattern and Clinical Outcomes in HR+/HER2- mBC
The study aims to describe demographics, clinical characteristics, genetic test diagnosis, treatment patterns, and clinical outcomes in HR+/HER2- (including HER2-low, HER2-ultralow, and HER2-null) unresectable or metastatic breast cancer patients in China; and exploratory describe clinical outcomes by treatment regimens, also report the QoL and other patient-report outcomes (PRO) and to assess healthcare resource utilization (HCRU) and costs overall and by LoT.
Read the detailed description
The study consists of both retrospective and prospective components, defined relative to the index date.
- Conditions
- Breast Cancer
- Keywords
- Metastatic Breast Cancer, HR-Positive, HER2-Negative, Real-world data, Observational Study, Treatment Patterns, China
- Medical subject headings
- Breast Neoplasms
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 |
|---|---|---|
| Patients with HR+/HER2- unresectable or metastatic breast cancer | The study will include adult patients with HR+/HER2- (including HER2-low, HER2-ultralow, and HER2-null) unresectable or metastatic breast cancer who plan to initiate second-line (2L) systemic therapy or initiated 2L systemic therapy within 2 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients receiving different regimens in each Line of treatment (LoT)
Percentage of participants receiving each systemic regimen within a given LoT.
Measured: From baseline up to 5 years
Percentage of participants receiving different treatment sequence across LoTs
Percentage of participants receiving different treatment sequence among those who entered the subsequent LoT.
Measured: From baseline up to 5 years
The attrition rate after each Line of Treatment (LoT)
Among participants with a documented therapy end for a given LoT, the percentage who did not initiate the next LoT.
Measured: From baseline up to 5 years
Secondary outcomes (9)
Biomarker and Genetic Testing Pattern
Metrics include percentage of participants who undergo testing per biomarker/mutation within each LoT, testing timing, specimen type, assay method, and result distribution.
Measured: From baseline up to 5 years
Demographic characteristics
Metrics include descriptive statistics for age and counts for categorical variables
Measured: At baseline
Percentage of Participants with AEs, TRAEs, and SAEs
Proportion of participants with AEs, TRAEs, and SAEs, by MedDRA SOC/PT and CTCAE v6.0 grade; proportions with AEs leading to dose modification, discontinuation, or death. Includes suspected drug, AE dates, seriousness, causality, and outcomes.
Measured: From baseline up to 5 years
Clinical management of adverse events of special interest
Metrics include percentage of participants who underwent diagnostic tests, prophylactic medications, therapeutic medications, dose modifications of treatment regimens, and follow-up assessments.
Measured: From baseline up to 5 years
Eastern Cooperative Oncology Group Performance Status (ECOG PS)
Percentage of participants with different ECOG PS
Measured: At baseline
ER/PR status
Percentage of participants with different ER (estrogen receptor) and PR (progesterone receptor) status
Measured: At baseline
HER2 status
Percentage of participants with different HER2 (human epidermal growth factor receptor 2) status
Measured: At baseline
TNM stage at diagnosis
Percentage of participants with different Tumor (T), Node (N), Metastasis (M) stage at diagnosis
Measured: At baseline
Endocrine resistance
Percentage of participants with different endocrine resistance status
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start5 Aug 2026 (estimated)
- Primary completion4 Aug 2031 (estimated)
- Study completion4 Aug 2031 (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 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
- Case-control
- Time perspective
- Other
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07743944
- Sponsor's protocol ID
- D3615R00009
- Acronym
- VERITAS
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2026
- Last updated
- 4 Aug 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 Vivli.org. 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 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VERITAS Longitudinal Real-world Registry of HR+/HER2- mBC to Understand Treatment Pattern and Clinical Outcomes in HR+/HER2- mBC
- ClinicalTrials.gov ID
- NCT07743944
- Acronym / sponsor ID
- VERITAS / D3615R00009
- Conditions
- Breast Cancer
- Keywords
- Metastatic Breast Cancer, HR-Positive, HER2-Negative, Real-world data, Observational Study, Treatment Patterns, China
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 2026 (estimated)
- Primary completion
- 4 Aug 2031 (estimated)
- Study completion
- 4 Aug 2031 (estimated)
- First posted
- 4 Aug 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.
The study aims to describe demographics, clinical characteristics, genetic test diagnosis, treatment patterns, and clinical outcomes in HR+/HER2- (including HER2-low, HER2-ultralow, and HER2-null) unresectable or metastatic breast cancer patients in China; and exploratory describe clinical outcomes by treatment regimens, also report the QoL and other patient-report outcomes (PRO) and to assess healthcare resource utilization (HCRU) and costs overall and by LoT.
Detailed description
The study consists of both retrospective and prospective components, defined relative to the index date.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with HR+/HER2- unresectable or metastatic breast cancer | – | –The study will include adult patients with HR+/HER2- (including HER2-low, HER2-ultralow, and HER2-null) unresectable or metastatic breast cancer who plan to initiate second-line (2L) systemic therapy or initiated 2L systemic therapy within 2 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes Chinese adult patients with HR+/HER2- (including HER2-low, HER2-ultralow, and HER2-null) unresectable or metastatic breast cancer who are about to initiate 2L systemic therapy or initiated 2L systemic therapy within 2 months at participating sites.
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
Percentage of patients receiving different regimens in each Line of treatment (LoT)
Time frame: From baseline up to 5 years
Percentage of participants receiving each systemic regimen within a given LoT.
Percentage of participants receiving different treatment sequence across LoTs
Time frame: From baseline up to 5 years
Percentage of participants receiving different treatment sequence among those who entered the subsequent LoT.
The attrition rate after each Line of Treatment (LoT)
Time frame: From baseline up to 5 years
Among participants with a documented therapy end for a given LoT, the percentage who did not initiate the next LoT.
9 secondary outcomes
Biomarker and Genetic Testing Pattern
Time frame: From baseline up to 5 years
Demographic characteristics
Time frame: At baseline
Percentage of Participants with AEs, TRAEs, and SAEs
Time frame: From baseline up to 5 years
Clinical management of adverse events of special interest
Time frame: From baseline up to 5 years
Eastern Cooperative Oncology Group Performance Status (ECOG PS)
Time frame: At baseline
ER/PR status
Time frame: At baseline
HER2 status
Time frame: At baseline
TNM stage at diagnosis
Time frame: At baseline
Endocrine resistance
Time frame: At baseline
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 4 Aug 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 Vivli.org. 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.
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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.
Astra Zeneca Clinical Study Information Center contact
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 AstraZeneca 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?
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 4 Aug 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?
Contact Astra Zeneca 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?
Percentage of patients receiving different regimens in each Line of treatment (LoT) (time frame: From baseline up to 5 years). The study lists 3 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 4 Aug 2026.