Clinical trial NCT05769751: A Study to Describe the Real-world Treatment Patterns and Associated Outcomes in Patients of China With HER2-positive Unresectable or Metastatic Breast Cancer
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HER2-positive Breast Cancer
Keywords: HER2-positive Breast Cancer
Real-world study
Treatment patterns
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2023-03-15
Enrollment: 865
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Receiving Each Regimen in Each Treatment Line
timeFrame: Assessed over a 2 year, 8 month time period
measure: Treatment Sequence Since the Time of Diagnosis of HER2-positive Unresectable or Metastatic Breast Cancer
timeFrame: Assessed over a 2 year, 8 month time period
measure: Percentage of Participants Receiving Endocrine Therapy if Breast Cancer is Hormone Receptor Positive
timeFrame: Assessed over a 2 year, 8 month time period
measure: Percentage of Participants Receiving Local and Regional Treatment for Metastasis (Radiotherapy and/or Surgery) and Osteoprotective Therapy
timeFrame: Assessed over a 2 year, 8 month time period
Secondary outcomes:
measure: Percentage of Participants With HER2-positive Unresectable or Metastatic Breast Cancer, Based on Demographic and Clinicopathological Characteristics
timeFrame: Assessed over a 2 year, 8 month time period
measure: Real-world Progression-free Survival (rwPFS) in Participants With HER2-positive Unresectable or Metastatic Breast Cancer
timeFrame: Assessed over a 2 year, 8 month time period
measure: Time to Next Treatment (TTNT) in Participants With HER2-positive Unresectable or Metastatic Breast Cancer
timeFrame: Assessed over a 2 year, 8 month time period
measure: Duration of Treatment (DoT) in Participants With HER2-positive Unresectable or Metastatic Breast Cancer
timeFrame: Assessed over a 2 year, 8 month time period
measure: Real-world Objective Response Rate (rwORR) in Participants With HER2-positive Unresectable or Metastatic Breast Cancer
timeFrame: Assessed over a 2 year, 8 month time period
measure: Real-world Disease Control Rate (rwDCR) in Participants With HER2-positive Unresectable or Metastatic Breast Cancer
timeFrame: Assessed over a 2 year, 8 month time period
measure: Real-world Duration of Response (rwDoR) in Participants With HER2-positive Unresectable or Metastatic Breast Cancer
timeFrame: Assessed over a 2 year, 8 month time period
measure: Percentage of Participants With Brain Metastases Per Line of Treatment in Participants With HER2-positive Unresectable or Metastatic Breast Cancer
timeFrame: Assessed over a 2 year, 8 month time period
measure: Percentage of Participants With HER2-positive Unresectable or Metastatic Breast Cancer, Based on Clinical Characteristics of Brain Lesions
timeFrame: Assessed over a 2 year, 8 month time period
measure: Percentage of Participants Receiving Radiotherapy or Surgery in Participants With HER2-positive Unresectable or Metastatic Breast Cancer
timeFrame: Assessed over a 2 year, 8 month time period
measure: Treatment Pattern After Diagnosis of Brain Metastases in Participants With HER2-positive Unresectable or Metastatic Breast Cancer
timeFrame: Assessed over a 2 year, 8 month time period
measure: Real-world Progression-free Survival (rwPFS) After Diagnosis of Brain Metastases in Participants With HER2-positive Unresectable or Metastatic Breast Cancer
timeFrame: Assessed over a 2 year, 8 month time period
measure: Time to Next Treatment (TTNT) After Diagnosis of Brain Metastases in Participants With HER2-positive Unresectable or Metastatic Breast Cancer
timeFrame: Assessed over a 2 year, 8 month time period
measure: Percentage of Participants With Adverse Events (AE) Leading to Treatment Discontinuation or Dose Modification
timeFrame: Assessed over a 2 year, 8 month time period
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
city: Jinan
country: China
facility: Affiliated Cancer Hospital of Shandong First Medical University
city: Shenyang
country: China
facility: Liaoning Cancer Hospital
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
Study officials:
affiliation: Daiichi Sankyo
name: Clinical Team Leader
role: STUDY_DIRECTOR
References: