A Real-world Study Observing Treatment Patterns and Clinical Results for Patients in China With Hormone Receptor-positive, HER2-negative Metastatic Breast Cancer. (VERITAS)
29 juli 2026 bijgewerkt door: AstraZeneca
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.
Studie Overzicht
Toestand
Werving
Conditie
Gedetailleerde beschrijving
The study consists of both retrospective and prospective components, defined relative to the index date.
Studietype
Observationeel
Inschrijving (Geschat)
2000
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Astra Zeneca Clinical Study Information Center
- Telefoonnummer: 1-877-240-9479
- E-mail: information.center@astrazeneca.com
Studie Locaties
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Jiangsu
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Nanjing, Jiangsu, China, 210029
- Werving
- The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital)
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
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.
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Percentage of patients receiving different regimens in each Line of treatment (LoT)
Tijdsspanne: From baseline up to 5 years
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Percentage of participants receiving each systemic regimen within a given LoT.
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From baseline up to 5 years
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Percentage of participants receiving different treatment sequence across LoTs
Tijdsspanne: From baseline up to 5 years
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Percentage of participants receiving different treatment sequence among those who entered the subsequent LoT.
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From baseline up to 5 years
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The attrition rate after each Line of Treatment (LoT)
Tijdsspanne: From baseline up to 5 years
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Among participants with a documented therapy end for a given LoT, the percentage who did not initiate the next LoT.
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From baseline up to 5 years
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Biomarker and Genetic Testing Pattern
Tijdsspanne: From baseline up to 5 years
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Metrics include percentage of participants who undergo testing per biomarker/mutation within each LoT, testing timing, specimen type, assay method, and result distribution.
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From baseline up to 5 years
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Demographic characteristics
Tijdsspanne: At baseline
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Metrics include descriptive statistics for age and counts for categorical variables
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At baseline
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Percentage of Participants with AEs, TRAEs, and SAEs
Tijdsspanne: From baseline up to 5 years
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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.
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From baseline up to 5 years
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Clinical management of adverse events of special interest
Tijdsspanne: From baseline up to 5 years
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Metrics include percentage of participants who underwent diagnostic tests, prophylactic medications, therapeutic medications, dose modifications of treatment regimens, and follow-up assessments.
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From baseline up to 5 years
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Eastern Cooperative Oncology Group Performance Status (ECOG PS)
Tijdsspanne: At baseline
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Percentage of participants with different ECOG PS
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At baseline
|
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ER/PR status
Tijdsspanne: At baseline
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Percentage of participants with different ER (estrogen receptor) and PR (progesterone receptor) status
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At baseline
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HER2 status
Tijdsspanne: At baseline
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Percentage of participants with different HER2 (human epidermal growth factor receptor 2) status
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At baseline
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TNM stage at diagnosis
Tijdsspanne: At baseline
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Percentage of participants with different Tumor (T), Node (N), Metastasis (M) stage at diagnosis
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At baseline
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Endocrine resistance
Tijdsspanne: At baseline
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Percentage of participants with different endocrine resistance status
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At baseline
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
5 augustus 2026
Primaire voltooiing (Geschat)
4 augustus 2031
Studie voltooiing (Geschat)
4 augustus 2031
Studieregistratiedata
Eerst ingediend
10 juli 2026
Eerst ingediend dat voldeed aan de QC-criteria
29 juli 2026
Eerst geplaatst (Werkelijk)
4 augustus 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
4 augustus 2026
Laatste update ingediend die voldeed aan QC-criteria
29 juli 2026
Laatst geverifieerd
1 juli 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- D3615R00009
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
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.
IPD-tijdsbestek voor delen
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles.
For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD-toegangscriteria voor delen
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.
Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- MVO
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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