Human Epidermal Growth Factor Receptor 2 (HER2) Positive Unresectable Locally Advanced or Metastatic Breast Cancer Disease Registry Study (ESTHER)

February 20, 2024 updated by: Hoffmann-La Roche

UK - A Disease Registry Study to Prospectively Observe Treatment Patterns and Outcomes in Patients With HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer

This disease registry is a prospective, multicenter non-interventional study designed to observe the different anticancer treatment regimens and their sequencing throughout the course of the disease in participants with unresectable locally advanced breast cancer (LABC) or metastatic breast cancer (mBC) and to describe the clinical outcome for each treatment regimen measured as progression-free survival.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
311

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Canterbury, United Kingdom, CT1 3NG
        • Kent & Canterbury Hospital
      • Chesterfield, United Kingdom, S44 5BL
        • Chesterfield Royal Hospital
      • Cornwall, United Kingdom, TR1 3LQ
        • Royal Cornwall Hospital; Dept of Clinical Oncology
      • Cottingham, United Kingdom, HU16 5JG
        • Castle Hill Hospital; The Queens Centre for Oncology and Haematology
      • East Kilbride, United Kingdom, G75 8RG
        • Hairmyres Hospital; Oncology Dept
      • Gateshead, United Kingdom, NE9 6SX
        • Queen Elizabeth Hospital
      • Inverness, United Kingdom, IV2 3UV
        • Raigmore Hospital
      • Larbert, United Kingdom, FK5 4QE
        • Forth Valley Royal Hospital ; Oncology Department
      • London, United Kingdom, SW3 6JJ
        • Royal Marsden Hospital; Dept of Med-Onc
      • London, United Kingdom, W6 8RF
        • Charing Cross Hospital; Medical Oncology.
      • London, United Kingdom, SE18 4QH
        • Queen Elizabeth Hospital
      • Macclesfield, United Kingdom, SK10 3BL
        • Macclesfield District General Hospital
      • Maidstone, United Kingdom, ME16 9QQ
        • Maidstone Hospital; Kent Oncology Centre
      • Manchester, United Kingdom, M2O 4BX
        • Christie Hospital Nhs Trust; Medical Oncology
      • Middlesbrough, United Kingdom, TS4 3BW
        • James Cook University Hospital; Oncology and Radiology
      • Northampton, United Kingdom, NN1 5BD
        • Northampton General Hospital NHS Trust;Oncology Unit
      • Northwood, United Kingdom, HA6 2RN
        • Mount Vernon & Watford Trust Hospital; Dept. of Clinical Oncology
      • Norwich, United Kingdom, NR4 7UY
        • Norfolk & Norwich University Hospital; Oncology Department
      • Nottingham, United Kingdom, NG5 1PB
        • Nottingham City Hospital; Oncology
      • Plymouth, United Kingdom, PL6 8DH
        • Derriford Hospital; Plymouth Oncology Centre
      • Preston, United Kingdom, PR2 9HT
        • Royal Preston Hosp; Rosemere Cancer Ctr
      • Rhyl, United Kingdom, LL18 5UJ
        • North Wales Cancer Treatment Centre, Glan Clwyd Hospital
      • Scarborough, United Kingdom, YO12 6QL
        • Scarborough General Hospital
      • Shrewsbury, United Kingdom, SY3 8XQ
        • Royal Shrewsbury Hospitals Nhs Trust; Oncology
      • Sutton, United Kingdom, SM2 5PT
        • Royal Marsden Hospital; Dept of Medical Oncology
      • Swansea, United Kingdom, SA2 8QA
        • Singleton Hospital; Pharmacy
      • Swindon, United Kingdom, SN3 6BB
        • Great Western Hospital, Swindon Cancer Research Unit; Osprey Unit Level 3
      • Wakefield, United Kingdom, WF1 4DG
        • Pinderfields Hospital; Clinical Research Team, Rowan House
      • Yeovil, United Kingdom, BA21 4AT
        • Yeovil District Hospital; Macmillan Unit
      • York, United Kingdom, BD20 6TD
        • Airedale General Hospital; Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Participants with HER2-positive unresectable LABC or mBC

Description

Inclusion Criteria:

  • Initially diagnosed with HER2-positive unresectable LABC or mBC no more than 6 months prior to enrollment, although they can have received anti-cancer treatment during that time
  • Able and willing to provide written informed consent and to comply with the study protocol

Exclusion Criteria:

- There are no exclusion criteria for entry into this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Participants With HER2-Positive Breast Cancer
Enrolled participants will receive treatment and clinical assessments for their HER2-positive unresectable LABC/mBC as determined by their treating physician, according to the standard of care and routine clinical practice at each site. Participants will be followed until death, withdrawal of consent or study termination, whichever occurs first. Study protocol does not specify any particular drug or treatment regimen.
Other: No intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Receiving Each Unique Treatment Regimen Overall
Time Frame: Baseline up to approximately 8 years
Baseline up to approximately 8 years
Percentage of Participants Receiving Each Unique Treatment Regimen as First-Line Versus Subsequent-Line Therapy
Time Frame: Baseline up to approximately 8 years
Baseline up to approximately 8 years
Percentage of Participants Receiving Each Unique Treatment Regimen Sequence
Time Frame: Baseline up to approximately 8 years
Baseline up to approximately 8 years
Progression-Free Survival
Time Frame: From start date of anti-cancer treatment regimen to the date of either disease progression or death (up to approximately 8 years)
Tumor response will be evaluated by the Investigator according to site-specific medical practice. Study protocol does not specify any particular method of assessment.
From start date of anti-cancer treatment regimen to the date of either disease progression or death (up to approximately 8 years)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Time Frame: Baseline up to approximately 8 years
Baseline up to approximately 8 years
Overall Survival (OS)
Time Frame: From the date of initiation of treatment to the date of death from any cause (up to approximately 8 years)
From the date of initiation of treatment to the date of death from any cause (up to approximately 8 years)
Number of Treatment Regimens Received
Time Frame: Baseline up to approximately 8 years
Baseline up to approximately 8 years
Percentage of Participants by Reasons for Treatment Modification
Time Frame: Baseline up to approximately 8 years
Baseline up to approximately 8 years
Percentage of Participants With Objective Response of Complete Response (CR) or Partial Response (PR)
Time Frame: From the date of initiation of treatment to the date of disease progression or death from any cause (up to approximately 8 years)
Tumor response will be evaluated by the Investigator according to site-specific medical practice. Study protocol does not specify any particular method of assessment.
From the date of initiation of treatment to the date of disease progression or death from any cause (up to approximately 8 years)
Duration of Response (DoR)
Time Frame: From date of first response (CR or PR) to the date of disease progression (up to approximately 8 years)
Tumor response will be evaluated by the Investigator according to site-specific medical practice. Study protocol does not specify any particular method of assessment.
From date of first response (CR or PR) to the date of disease progression (up to approximately 8 years)
Time to Treatment Failure
Time Frame: From the date of initiation of treatment to the date of treatment stopped or switched or death from any cause (up to approximately 8 years)
From the date of initiation of treatment to the date of treatment stopped or switched or death from any cause (up to approximately 8 years)
Percentage of Participants With Central Nervous System (CNS) as First Site of Progression
Time Frame: From the date of initiation of treatment to the date of disease progression or death from any cause (up to approximately 8 years)
From the date of initiation of treatment to the date of disease progression or death from any cause (up to approximately 8 years)
Percentage of Participants Receiving Each Treatment Regimen Categorized by Participant Characteristics
Time Frame: Baseline up to approximately 8 years
Baseline up to approximately 8 years
Euro Quality of Life 5-Dimension Questionnaire (EQ-5D) Score
Time Frame: Baseline up to approximately 8 years (assessed every 3 months)
Baseline up to approximately 8 years (assessed every 3 months)
Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire Score
Time Frame: Baseline up to approximately 8 years (assessed every 3 months)
Baseline up to approximately 8 years (assessed every 3 months)
Work Productivity and Activity Impairment (WPAI) Questionnaire Score
Time Frame: Baseline up to approximately 8 years (assessed every 3 months)
Baseline up to approximately 8 years (assessed every 3 months)
Percentage of Participants with Different Anti-Cancer Treatment Regimens by Country
Time Frame: Baseline up to approximately 8 years
Baseline up to approximately 8 years
Percentage of Participants with History of Breast Cancer by Different Anti-Cancer Treatment Regimens
Time Frame: Baseline up to approximately 8 years
Baseline up to approximately 8 years
Percentage of Participants with CNS-only Disease Progression
Time Frame: From the date of initiation of treatment to the date of disease progression or death from any cause (up to approximately 8 years)
From the date of initiation of treatment to the date of disease progression or death from any cause (up to approximately 8 years)
Percentage of Participants with Oligometastatic Disease Categorized by Different Anti-Cancer Treatment Regimens
Time Frame: Baseline up to approximately 8 years
Baseline up to approximately 8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 23, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 19, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 19, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ML29659

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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