AzTrials
AzTrials

HER2-positive Breast CancerNCT05769751

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

An observational study of HER2-positive Breast Cancer, run by Daiichi Sankyo at 5 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HER2-positive Breast Cancer
What is being tested?
Electronic medical record and hospital information system or other available resources
How many people
865 participants
Where
5 sitesChina
Study dates
15 Mar 2023to 25 Jul 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

China5 sites

  • Sun Yat-sen University Cancer Center

    Guangzhou, 510060

  • Zhejiang Cancer Hospital

    Hangzhou, 31002

  • Affiliated Cancer Hospital of Shandong First Medical University

    Jinan, 250117

  • Liaoning Cancer Hospital

    Shenyang, 110042

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, 300060

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Electronic medical record and hospital information system or other available resources
Keywords
HER2-positive Breast Cancer, Real-world study, Treatment patterns

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Electronic medical record and hospital information system or other available resourcesOther

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

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 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

    Measured: Assessed over a 2 year, 8 month time period

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

    Measured: 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

    Measured: Assessed over a 2 year, 8 month time period

Secondary outcomes (14)

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

    Measured: 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

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

    Measured: Assessed over a 2 year, 8 month time period

  3. 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.

    Measured: Assessed over a 2 year, 8 month time period

  4. 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.

    Measured: Assessed over a 2 year, 8 month time period

  5. 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.

    Measured: Assessed over a 2 year, 8 month time period

  6. 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.

    Measured: Assessed over a 2 year, 8 month time period

  7. 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.

    Measured: Assessed over a 2 year, 8 month time period

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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

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

    Measured: Assessed over a 2 year, 8 month time period

  13. 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.

    Measured: Assessed over a 2 year, 8 month time period

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

    Measured: Assessed over a 2 year, 8 month time period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2023
  2. Study start15 Mar 2023
  3. Primary completion25 Jul 2023
  4. Study completion25 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
865 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05769751
Sponsor's protocol ID
DSCN-EHT-NIS-BC001
Status last verified
Aug 2023
First submitted
3 Mar 2023
Last updated
16 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of HER2-positive Breast Cancer, run by Daiichi Sankyo at 5 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Receiving Each Regimen in Each Treatment Line (time frame: Assessed over a 2 year, 8 month time period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05769751.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in