Breast Cancer Real-World Insights and Decision Guidance Evaluation in Hong Kong (BRIDGE-HK)
Breast Cancer Real-World Insights and Decision Guidance Evaluation (BRIDGE-HK) An Observational, Retrospective, Real-world Study on Breast Cancer Patients in Hong Kong Using the Hospital Authority CDARS Database
Breast cancer is the most common cancer affecting women in Hong Kong, but comprehensive real-world evidence on treatment and outcomes remains limited. This retrospective observational study will use Hong Kong Hospital Authority electronic health records, covering approximately 80% of healthcare utilisation, to evaluate around 45,000 adult women treated between 2018 and 2025. The study will describe patient characteristics, treatment patterns, treatment sequences, treatment duration, discontinuation, response, overall survival, and progression-free survival across HER2-positive, hormone receptor-positive/HER2-negative, and triple-negative subtypes. It will also assess neoadjuvant therapy, pathological complete response, and disease-free survival in eligible early-stage patients.
A tanulmány áttekintése
Állapot
Körülmények
Tanulmány típusa
Beiratkozás (Becsült)
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: AstraZeneca Clinical Study Information Center
- Telefonszám: 1-877-240-9479
- E-mail: information.center@astrazeneca.com
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Mintavételi módszer
Tanulmányi populáció
Female breast cancer patients are anticipated, determined by data availability in the Hong Kong HA database (2018-2025).
Leírás
Inclusion Criteria:
- Female sex
- Age ≥18 years at the time of breast cancer diagnosis (index date)
- Histologically confirmed diagnosis of breast cancer (invasive or in situ) recorded in the HA database in all available records
- Documentation of surgery, or at least one systemic therapy (chemotherapy, endocrine therapy, targeted therapy, or immunotherapy) administered after the breast cancer diagnosis, as evidenced by pharmacy dispensing records or treatment administration records in the HA database between January 1, 2018, and December 31, 2025
- Availability of at least 6 months of follow-up data in the HA database after the index date, unless death occurs within the 6-month period
Exclusion Criteria:
- Male sex
- History of any other primary malignancy diagnosed prior to the index date (other than basal cell carcinoma of the skin and squamous cell carcinoma of the skin) as identified through ICD-9-CM codes 140.x-172.x, 176.x-208.x (excluding 174.x) recorded in the HA database during the 120-month baseline lookback period
- Patients with documented participation in an interventional clinical trial during the study period, where such information is available in the HA database, to preserve the real-world representativeness of observed treatment patterns
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Megfigyelési modellek: COHORT
- Időperspektívák: RETROSPECTIVE
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Sociodemographic Characteristics
Időkeret: female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
|
Age at diagnosis |
female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
|
|
Sociodemographic Characteristics
Időkeret: female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
|
Ethnicity |
female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
|
|
Clinical Characteristics
Időkeret: female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
|
Breast cancer subtype |
female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
|
|
Clinical Characteristics
Időkeret: female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
|
Disease stage at diagnosis |
female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
|
|
Clinical Characteristics
Időkeret: female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
|
Histological grade |
female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
|
|
Clinical Characteristics
Időkeret: female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
|
Tumor size |
female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
|
|
Clinical Characteristics
Időkeret: female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
|
Nodal status |
female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
|
|
Clinical Characteristics
Időkeret: female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
|
ECOG performance status |
female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
|
|
Real-world treatment outcome
Időkeret: female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
|
real-world overall survival |
female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
|
|
Real-world treatment outcome
Időkeret: female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
|
Real-world progression-free survival |
female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
|
|
Real-world treatment outcome
Időkeret: female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
|
Treatment response status |
female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
|
Együttműködők és nyomozók
Szponzor
Nyomozók
- Kutatásvezető: Matthew Chiu, Clinical Assistant Professor, Department of Clinical Oncology, the University of Hong Kong
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- D9673R00093
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
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.
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles.
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment https://vivli.org/. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
IPD megosztási időkeret
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-megosztási hozzáférési feltételek
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.
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .