Skip to main content
OpenTrials
Completed

NCT Number: 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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HER2-positive Breast Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sun Yat-sen University Cancer Center, Guangzhou, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Percentage of Participants Receiving Each Regimen in Each Treatment Line

    Time frame: Assessed over a 2 year, 8 month time period

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

    Time frame: Assessed over a 2 year, 8 month time period

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

    Time frame: Assessed over a 2 year, 8 month time period

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

    Time frame: Assessed over a 2 year, 8 month time period

Secondary outcomes

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

    Time frame: Assessed over a 2 year, 8 month time period

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

    Time frame: Assessed over a 2 year, 8 month time period

    Real-world progression-free survival (rwPFS) is defined as the time from initiation of treatment to disease progression or death due to any cause.

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

    Time frame: Assessed over a 2 year, 8 month time period

    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.

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

    Time frame: Assessed over a 2 year, 8 month time period

    Duration of treatment is defined as the length of time a patient is treated.

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

    Time frame: Assessed over a 2 year, 8 month time period

    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.

  6. Real-world Disease Control Rate (rwDCR) in Participants With HER2-positive Unresectable or Metastatic Breast Cancer

    Time frame: Assessed over a 2 year, 8 month time period

    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.

  7. Real-world Duration of Response (rwDoR) in Participants With HER2-positive Unresectable or Metastatic Breast Cancer

    Time frame: Assessed over a 2 year, 8 month time period

    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.

  8. Percentage of Participants With Brain Metastases Per Line of Treatment in Participants With HER2-positive Unresectable or Metastatic Breast Cancer

    Time frame: Assessed over a 2 year, 8 month time period

  9. Percentage of Participants With HER2-positive Unresectable or Metastatic Breast Cancer, Based on Clinical Characteristics of Brain Lesions

    Time frame: Assessed over a 2 year, 8 month time period

  10. Percentage of Participants Receiving Radiotherapy or Surgery in Participants With HER2-positive Unresectable or Metastatic Breast Cancer

    Time frame: Assessed over a 2 year, 8 month time period

  11. Treatment Pattern After Diagnosis of Brain Metastases in Participants With HER2-positive Unresectable or Metastatic Breast Cancer

    Time frame: Assessed over a 2 year, 8 month time period

  12. Real-world Progression-free Survival (rwPFS) After Diagnosis of Brain Metastases in Participants With HER2-positive Unresectable or Metastatic Breast Cancer

    Time frame: Assessed over a 2 year, 8 month time period

    Real-world progression-free survival (rwPFS) is defined as the time from initiation of treatment to disease progression or death due to any cause.

  13. Time to Next Treatment (TTNT) After Diagnosis of Brain Metastases in Participants With HER2-positive Unresectable or Metastatic Breast Cancer

    Time frame: Assessed over a 2 year, 8 month time period

    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.

  14. Percentage of Participants With Adverse Events (AE) Leading to Treatment Discontinuation or Dose Modification

    Time frame: Assessed over a 2 year, 8 month time period

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 15, 2023
Registry last updated
Aug 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.