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

HER2-positive Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05769751
• Other study ID #: DSCN-EHT-NIS-BC001
• Status: Completed
• Start date: March 15, 2023
• Est. completion date: July 25, 2023

Study information

• Verified date: August 2023
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 865
• Est. completion date: July 25, 2023
• Est. primary completion date: July 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• HER2-positive Breast Cancer

Intervention

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.

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou
China	Zhejiang Cancer Hospital	Hangzhou
China	Affiliated Cancer Hospital of Shandong First Medical University	Jinan
China	Liaoning Cancer Hospital	Shenyang
China	Tianjin Medical University Cancer Institute & Hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo, Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Receiving Each Regimen in Each Treatment Line		Assessed over a 2 year, 8 month time period
Primary	Treatment Sequence Since the Time of Diagnosis of HER2-positive Unresectable or Metastatic Breast Cancer		Assessed over a 2 year, 8 month time period
Primary	Percentage of Participants Receiving Endocrine Therapy if Breast Cancer is Hormone Receptor Positive		Assessed over a 2 year, 8 month time period
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Percentage of Participants With Adverse Events (AE) Leading to Treatment Discontinuation or Dose Modification		Assessed over a 2 year, 8 month time period