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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Neoplasms

• Study Type: Observational
• Enrollment (Estimated): 48000

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Female breast cancer patients are anticipated, determined by data availability in the Hong Kong HA database (2018-2025).

Description

Inclusion Criteria:

1. Female sex
2. Age ≥18 years at the time of breast cancer diagnosis (index date)
3. Histologically confirmed diagnosis of breast cancer (invasive or in situ) recorded in the HA database in all available records
4. 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
5. 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:

1. Male sex
2. 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
3. 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

Study Plan

How is the study designed?

Design Details

• Observational Models: COHORT
• Time Perspectives: RETROSPECTIVE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sociodemographic Characteristics	Age at diagnosis	female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
Sociodemographic Characteristics	Ethnicity	female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
Clinical Characteristics	Breast cancer subtype	female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
Clinical Characteristics	Disease stage at diagnosis	female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
Clinical Characteristics	Histological grade	female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
Clinical Characteristics	Tumor size	female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
Clinical Characteristics	Nodal status	female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
Clinical Characteristics	ECOG performance status	female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
Real-world treatment outcome	real-world overall survival	female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
Real-world treatment outcome	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	Treatment response status	female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Matthew Chiu, Clinical Assistant Professor, Department of Clinical Oncology, the University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Estimated): November 2, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: October 15, 2026
• First Submitted That Met QC Criteria: November 2, 2026
• First Posted (Actual): November 4, 2026

Study Record Updates

• Last Update Posted (Actual): November 4, 2026
• Last Update Submitted That Met QC Criteria: November 2, 2026
• Last Verified: October 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: D9673R00093

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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 Sharing Time Frame

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 Sharing Access Criteria

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.