Home
Clinical Trials
Study to Describe the Real-wo...

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

Last Updated: 2024-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

763 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-14

Study Completion Date

2022-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This multicountry, multicenter, retrospective, non-interventional study involving patients diagnosed with HER2-positive unresectable or metastatic breast cancer mBC will be conducted to understand the demographic and clinico-pathological profile of the patients, diagnostic practices for human epidermal growth factor receptor 2 (HER2) status, current treatment landscape and sequencing of therapies, associated burden of toxicities with all lines of treatment (LOTs), and survival outcomes in the real-world setting.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Observational Study on the Treatment of Patients With Metastatic Breast Cancer

NCT06676436

Cancer

RECRUITING

Estimation of the Prevalence of HER2 Low and Describe the SoC, Treatment Patterns, and Outcome in Real-world Practice Among Unresectable and/or Metastatic Breast Cancer Patients With HER2 Low Status

NCT04807595

Breast Cancer

COMPLETED

BRaziLian outcomE for metAStatic breasT Cancer

NCT05559528

Metastatic Breast Cancer Breast Cancer Stage IV

UNKNOWN

HER2(Human Epidermal Growth Factor Receptor 2) -Positive Metastatic Breast Cancer in Russia

NCT05905939

Breast Cancer

COMPLETED

A Study To Observe Treatment Patterns and Outcomes in Patients With HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer

NCT02616224

Breast Cancer, HER2 Positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer

WITHDRAWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study will involve patients diagnosed with HER2-positive unresectable or mBC since the earlier date between the date of trastuzumab emtansine (\[T-DM1\] Kadcyla) becoming available through reimbursement or patient access programme as a valid local treatment option or 01 January 2017 and who received at least 1 LOT. The data will be collected from the date of diagnosis of unresectable or mBC (index date) to the end of follow-up (ie, until death, the last medical record entry, or date of data extraction, whichever is earlier). The study will not have any study-specific patient visits or a longitudinal follow-up. All available data will be extracted from patients' medical records or obtained from patients themselves after obtaining an informed consent unless a waiver is granted by the local Institutional Review Board (IRB)/Institutional Ethics Committee (IEC)/Ethics Committee (EC). The informed consent may be obtained at the time of patients routine clinical care visit to the oncology centre. The data on different types of treatment received by the patients, socio-demographics, and clinico-pathological characteristics will be extracted from patients medical records up to the date informed consent was obtained.

This study will be conducted in non-US and non-European countries including Australia, Brazil, Hong Kong, Korea, Singapore and Taiwan. The total number of patients in the study will be approximately a minimum of 570 and a maximum of 830 patients. The study will be implemented at approximately 50 to 100 oncology centres spanning across 6 countries in the AstraZeneca (AZ) International Region (ie, non-US, non-European countries).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Metastatic Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Retrospective

Patients who are diagnosed with HER2-positive unresectable or mBC and have received at least 1 LOT in the advanced setting will be included. Approximately a total of 570-830 patients will be enrolled in the study.

None (Observational study)

Intervention Type OTHER

The data on different types of treatment received by the patients, socio-demographics, and clinico-pathological characteristics and healthcare resource utilisation will be extracted from patients' medical records (both alive and deceased).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

None (Observational study)

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Observational study

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adult female or male patients ≥18 years old or 'adults' according to the age of majority as defined by the local regulations
* Patient or next of kin/legal representative willing and able to provide written informed consent according to the local regulations unless a waiver is granted by the local IRB/IEC/EC
* Patients' medical records showing a diagnosis of HER2-positive unresectable or mBC (can be either de novo advanced disease, progression or recurrence of previous early-stage HER2-positive BC) since the available date of T-DM1 (Kadcyla) through reimbursement or patient access programme as a valid local treatment option or 01 January 2017, whichever is earlier and with the availability of at least 12 months of follow-up data (from the date of diagnosis of unresectable or mBC) in the medical records at the participating site, unless patient died within the first 12 months of diagnosis
* Patients completing at least 1 LOT for HER2-positive unresectable or mBC

Exclusion Criteria

* Patients with HER2-negative unresectable or mBC at index diagnosis
* Patients with a change in HER2 status from positive to negative at the progression from early-stage to advanced-stage disease (ie, shown on a repeat biopsy at diagnosis of advanced-stage disease) will be excluded (patients who change from HER2-positive to negative on repeat biopsy during treatment for advanced-stage disease may be included)
* Patients with concomitant cancer at the time of diagnosis of HER2-positive unresectable or mBC 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
* Patients who at the time of data collection for this study are participating or have participated in an interventional study that remains blinded

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers