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

Study Overview
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Brief Summary
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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.

Detailed Description
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The treatment landscape has changed dramatically with the lack of real-world evidence for usage and the efficacy of newly approved drugs in China. This multicenter, retrospective, non-interventional study will include patients newly diagnosed with HER2-positive unresectable or metastatic breast cancer, or first recurrent from early breast cancer. The primary objective of this real-world study is to describe the treatment patterns of HER2-positive unresectable or metastatic breast cancer in China. Secondary objectives will include describing the demographic and clinicopathological characteristics of patients, efficacy of different treatment regimens, treatment options and efficacy of brain metastases, and safety and tolerability of different treatment regimens in patients with HER2-positive unresectable or metastatic breast cancer.

Official Title
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A Multicenter, Non-interventional Retrospective Study to Describe the Real-world Treatment Patterns and Associated Outcomes in Patients of China With HER2-positive Unresectable or Metastatic Breast Cancer

Conditions
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HER2-positive Breast Cancer

Intervention / Treatment
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* Other: Electronic medical record and hospital information system or other available resources


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 Participants with critical missing data from their medical records or other patients deemed by the investigator to be ineligible for inclusion

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Electronic medical record and hospital information system or other available resources|This is a non-interventional study. No study medication will be provided to the participants.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Real-world progression-free survival (rwPFS) is defined as the time from initiation of treatment to disease progression or death due to any cause. | Assessed over a 2 year, 8 month time period | 
| Time to Next Treatment (TTNT) in Participants With HER2-positive Unresectable or Metastatic Breast Cancer | Time to next treatment is defined as the time from initiation of a systemic therapy to the date of initiation of the first subsequent systemic therapy regimen or death. | Assessed over a 2 year, 8 month time period | 
| Duration of Treatment (DoT) in Participants With HER2-positive Unresectable or Metastatic Breast Cancer | Duration of treatment is defined as the length of time a patient is treated. | 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 | Real-world objective response rate is defined as the percentage of participants who have a partial response or complete response to treatment within a certain period of time. | Assessed over a 2 year, 8 month time period | 
| Real-world Disease Control Rate (rwDCR) in Participants With HER2-positive Unresectable or Metastatic Breast Cancer | Real-world disease control rate is defined as the percentage of participants with advanced or metastatic cancer who have achieved complete response, partial response, and stable disease. | Assessed over a 2 year, 8 month time period | 
| Real-world Duration of Response (rwDoR) in Participants With HER2-positive Unresectable or Metastatic Breast Cancer | Real-world duration of response is defined as the time from randomization to disease progression or death in participants who achieve complete or partial response. | Assessed over a 2 year, 8 month time period | 
| Percentage of Participants With Brain Metastases Per Line of Treatment in Participants With HER2-positive Unresectable or Metastatic Breast Cancer |  | Assessed over a 2 year, 8 month time period | 
| Percentage of Participants With HER2-positive Unresectable or Metastatic Breast Cancer, Based on Clinical Characteristics of Brain Lesions |  | Assessed over a 2 year, 8 month time period | 
| Percentage of Participants Receiving Radiotherapy or Surgery in Participants With HER2-positive Unresectable or Metastatic Breast Cancer |  | Assessed over a 2 year, 8 month time period | 
| Treatment Pattern After Diagnosis of Brain Metastases in Participants With HER2-positive Unresectable or Metastatic Breast Cancer |  | Assessed over a 2 year, 8 month time period | 
| Real-world Progression-free Survival (rwPFS) After Diagnosis of Brain Metastases in Participants With HER2-positive Unresectable or Metastatic Breast Cancer | Real-world progression-free survival (rwPFS) is defined as the time from initiation of treatment to disease progression or death due to any cause. | Assessed over a 2 year, 8 month time period | 
| Time to Next Treatment (TTNT) After Diagnosis of Brain Metastases in Participants With HER2-positive Unresectable or Metastatic Breast Cancer | Time to next treatment is defined as the time from initiation of a systemic therapy to the date of initiation of the first subsequent systemic therapy regimen or death. | Assessed over a 2 year, 8 month time period | 
| Percentage of Participants With Adverse Events (AE) Leading to Treatment Discontinuation or Dose Modification |  | Assessed over a 2 year, 8 month time period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HER2-positive Breast Cancer, Real-world study, Treatment patterns