A Real-world Study Observing Treatment Patterns and Clinical Results for Patients in China With Hormone Receptor-positive, HER2-negative Metastatic Breast Cancer.

NCT07743944 | Recruiting

• 1 other identifier: D3615R00009
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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 regimens, also report the QoL and other patient-report outcomes (PRO) and to assess healthcare resource utilization (HCRU) and costs overall and by LoT.

Conditions

Breast Cancer

Keywords

Metastatic Breast Cancer; HR-Positive; HER2-Negative; Real-world data; Observational Study; Treatment Patterns; China

Outcome Measures

Primary Outcomes (3)

• Percentage of patients receiving different regimens in each Line of treatment (LoT)

  Percentage of participants receiving each systemic regimen within a given LoT.

  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.

  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.

  From baseline up to 5 years

Secondary Outcomes (9)

• Biomarker and Genetic Testing Pattern

  From baseline up to 5 years

• Demographic characteristics

  At baseline

• Percentage of Participants with AEs, TRAEs, and SAEs

  From baseline up to 5 years

• Clinical management of adverse events of special interest

  From baseline up to 5 years

• Eastern Cooperative Oncology Group Performance Status (ECOG PS)

  At baseline

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital)

Nanjing, Jiangsu, 210029, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Astra Zeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: August 4, 2026
• Study Start: August 5, 2026
• Primary Completion (Estimated): August 4, 2031
• Study Completion (Estimated): August 4, 2031
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• 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.

Locations

CN (1)