A Study to Describe the Real-world Treatment Patterns and Associated Outcomes in Patients of China With HER2-positive Unresectable or Metastatic Breast Cancer

NCT05769751 | Completed

• 1 other identifier: DSCN-EHT-NIS-BC001
• Study Type: observational
• Target: 865
• Locations: 1 country
• Sites: 5

Brief Summary

This is a multicenter, non-interventional, retrospective, real-world study that enrolled patients diagnosed with HER2-positive unresectable or metastatic breast cancer. This study will be conducted to understand the treatment pattern and sequencing of therapies, survival outcomes, and associated burden of toxicities with line of treatment in the real world.

Conditions

HER2-positive Breast Cancer

Keywords

HER2-positive Breast Cancer; Real-world study; Treatment patterns

Outcome Measures

Primary Outcomes (4)

• Percentage of Participants Receiving Each Regimen in Each Treatment Line

  Assessed over a 2 year, 8 month time period

• Treatment Sequence Since the Time of Diagnosis of HER2-positive Unresectable or Metastatic Breast Cancer

  Assessed over a 2 year, 8 month time period

• Percentage of Participants Receiving Endocrine Therapy if Breast Cancer is Hormone Receptor Positive

  Assessed over a 2 year, 8 month time period

• Percentage of Participants Receiving Local and Regional Treatment for Metastasis (Radiotherapy and/or Surgery) and Osteoprotective Therapy

  Assessed over a 2 year, 8 month time period

Secondary Outcomes (14)

• Percentage of Participants With HER2-positive Unresectable or Metastatic Breast Cancer, Based on Demographic and Clinicopathological Characteristics

  Assessed over a 2 year, 8 month time period

• Real-world Progression-free Survival (rwPFS) in Participants With HER2-positive Unresectable or Metastatic Breast Cancer

  Assessed over a 2 year, 8 month time period

• Time to Next Treatment (TTNT) in Participants With HER2-positive Unresectable or Metastatic Breast Cancer

  Assessed over a 2 year, 8 month time period

• Duration of Treatment (DoT) in Participants With HER2-positive Unresectable or Metastatic Breast Cancer

  Assessed over a 2 year, 8 month time period

• Real-world Objective Response Rate (rwORR) in Participants With HER2-positive Unresectable or Metastatic Breast Cancer

  Assessed over a 2 year, 8 month time period

Interventions

Electronic medical record and hospital information system or other available resources OTHER

This is a non-interventional study. No study medication will be provided to the participants.

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 will be participants with a first diagnosis of HER2-positive unresectable or metastatic breast cancer or first recurrence between January 1, 2020 and August 31, 2022, who have at least one record of late systemic therapy, and were followed up until August 31, 2022. The study will be implemented at 4-6 top hospitals in Tier 1/2 cities spanning across China. Patient data will be retrospectively collected using the electronic medical record and hospital information system or other available resources, including laboratory test results, imaging, pathology reports, medical records, surgical records, prescription diagnoses, inpatient visits and hospitalizations.

You may qualify if:

• Male or female patients ≥ 18 years of age at the time of diagnosis of unresectable or metastatic breast cancer
• Participants with first diagnosis of unresectable or metastatic breast cancer, or first recurrence of HER2-positive breast cancer since January 1, 2020. Participants were eligible if they were HER2-positive in the early operable stage and HER2-negative in the advanced stage. HER2 positive was defined with the reference to the Chinese guidelines for HER2 positive breast cancer at the time of testing
• Participants have received at least one systemic therapy for advanced breast cancer

You may not qualify if:

• Participants with concomitant cancer at the time of diagnosis of HER2-positive unresectable or metastatic breast cancer, except for the non-metastatic non-melanoma skin cancers, or in situ or benign neoplasms; a cancer is considered concomitant if it occurs within 5 years of HER2-positive breast cancer diagnosis.
• Participants who are/were currently/previously enrolled in a clinical trial and have not been unblinded during the data collection interval of the study

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (5)

Sun Yat-sen University Cancer Center

Guangzhou, 510060, China

Location

Zhejiang Cancer Hospital

Hangzhou, 31002, China

Location

Affiliated Cancer Hospital of Shandong First Medical University

Jinan, 250117, China

Location

Liaoning Cancer Hospital

Shenyang, 110042, China

Location

Tianjin Medical University Cancer Institute & Hospital

Tianjin, 300060, China

Location

MeSH Terms

Interventions

Electronic Health Records; Hospital Information Systems

Intervention Hierarchy (Ancestors)

Medical Records Systems, Computerized; Medical Records; Records; Data Collection; Epidemiologic Methods; Investigative Techniques; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Hospital Administration; Health Facility Administration; Management Information Systems

Study Officials

• Clinical Team Leader

  Daiichi Sankyo

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: March 15, 2023
• Study Start: March 15, 2023
• Primary Completion: July 25, 2023
• Study Completion: July 25, 2023
• Last Updated: August 16, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)