Breast CancerESTHERNCT02393924
Human Epidermal Growth Factor Receptor 2 (HER2) Positive Unresectable Locally Advanced or Metastatic Breast Cancer Disease Registry Study
An observational study of Breast Cancer, run by Hoffmann-La Roche at 30 sites in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- How many people
- 311 participants
- Where
- 30 sitesUnited Kingdom
- Study dates
- 23 Feb 2015to 19 Apr 2023
- How long will I take part?
- 8 Years
- 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: Participants with HER2-positive unresectable LABC or mBC
Who may be able to join
- 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
Who cannot join
- There are no exclusion criteria for entry into this study
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United Kingdom30 sites
Kent & Canterbury Hospital
Canterbury, CT1 3NG
Chesterfield Royal Hospital
Chesterfield, S44 5BL
Royal Cornwall Hospital; Dept of Clinical Oncology
Cornwall, TR1 3LQ
Castle Hill Hospital; The Queens Centre for Oncology and Haematology
Cottingham, HU16 5JG
Hairmyres Hospital; Oncology Dept
East Kilbride, G75 8RG
Queen Elizabeth Hospital
Gateshead, NE9 6SX
Raigmore Hospital
Inverness, IV2 3UV
Forth Valley Royal Hospital ; Oncology Department
Larbert, FK5 4QE
Queen Elizabeth Hospital
London, SE18 4QH
Royal Marsden Hospital; Dept of Med-Onc
London, SW3 6JJ
Charing Cross Hospital; Medical Oncology.
London, W6 8RF
Macclesfield District General Hospital
Macclesfield, SK10 3BL
Maidstone Hospital; Kent Oncology Centre
Maidstone, ME16 9QQ
Christie Hospital Nhs Trust; Medical Oncology
Manchester, M2O 4BX
James Cook University Hospital; Oncology and Radiology
Middlesbrough, TS4 3BW
Northampton General Hospital NHS Trust;Oncology Unit
Northampton, NN1 5BD
Mount Vernon & Watford Trust Hospital; Dept. of Clinical Oncology
Northwood, HA6 2RN
Norfolk & Norwich University Hospital; Oncology Department
Norwich, NR4 7UY
Nottingham City Hospital; Oncology
Nottingham, NG5 1PB
Derriford Hospital; Plymouth Oncology Centre
Plymouth, PL6 8DH
Royal Preston Hosp; Rosemere Cancer Ctr
Preston, PR2 9HT
North Wales Cancer Treatment Centre, Glan Clwyd Hospital
Rhyl, LL18 5UJ
Scarborough General Hospital
Scarborough, YO12 6QL
Royal Shrewsbury Hospitals Nhs Trust; Oncology
Shrewsbury, SY3 8XQ
Royal Marsden Hospital; Dept of Medical Oncology
Sutton, SM2 5PT
Singleton Hospital; Pharmacy
Swansea, SA2 8QA
Great Western Hospital, Swindon Cancer Research Unit; Osprey Unit Level 3
Swindon, SN3 6BB
Pinderfields Hospital; Clinical Research Team, Rowan House
Wakefield, WF1 4DG
Yeovil District Hospital; Macmillan Unit
Yeovil, BA21 4AT
Airedale General Hospital; Oncology
York, BD20 6TD
About this study
Official title: 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.
- Conditions
- Breast Cancer
- Being tested
- No intervention
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Receiving Each Unique Treatment Regimen Overall
Measured: Baseline up to approximately 8 years
Percentage of Participants Receiving Each Unique Treatment Regimen as First-Line Versus Subsequent-Line Therapy
Measured: Baseline up to approximately 8 years
Percentage of Participants Receiving Each Unique Treatment Regimen Sequence
Measured: Baseline up to approximately 8 years
Progression-Free Survival
Tumor response will be evaluated by the Investigator according to site-specific medical practice. Study protocol does not specify any particular method of assessment.
Measured: From start date of anti-cancer treatment regimen to the date of either disease progression or death (up to approximately 8 years)
Secondary outcomes (16)
Overall Survival (OS)
Measured: From the date of initiation of treatment to the date of death from any cause (up to approximately 8 years)
Percentage of Participants With Objective Response of Complete Response (CR) or Partial Response (PR)
Tumor response will be evaluated by the Investigator according to site-specific medical practice. Study protocol does not specify any particular method of assessment.
Measured: 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)
Tumor response will be evaluated by the Investigator according to site-specific medical practice. Study protocol does not specify any particular method of assessment.
Measured: From date of first response (CR or PR) to the date of disease progression (up to approximately 8 years)
Time to Treatment Failure
Measured: 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
Measured: 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 Adverse Events (AEs) and Serious AEs (SAEs)
Measured: Baseline up to approximately 8 years
Percentage of Participants by Reasons for Treatment Modification
Measured: Baseline up to approximately 8 years
Percentage of Participants Receiving Each Treatment Regimen Categorized by Participant Characteristics
Measured: Baseline up to approximately 8 years
Number of Treatment Regimens Received
Measured: Baseline up to approximately 8 years
Euro Quality of Life 5-Dimension Questionnaire (EQ-5D) Score
Measured: Baseline up to approximately 8 years (assessed every 3 months)
Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire Score
Measured: Baseline up to approximately 8 years (assessed every 3 months)
Work Productivity and Activity Impairment (WPAI) Questionnaire Score
Measured: Baseline up to approximately 8 years (assessed every 3 months)
Percentage of Participants with Different Anti-Cancer Treatment Regimens by Country
Measured: Baseline up to approximately 8 years
Percentage of Participants with History of Breast Cancer by Different Anti-Cancer Treatment Regimens
Measured: Baseline up to approximately 8 years
Percentage of Participants with CNS-only Disease Progression
Measured: 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
Measured: Baseline up to approximately 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2015 (estimated)
- Study start23 Feb 2015
- Primary completion19 Apr 2023
- Study completion19 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prospective
- Enrolment
- 311 participants (actual)
- Target duration
- 8 Years
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02393924
- Sponsor's protocol ID
- ML29659
- Acronym
- ESTHER
- Status last verified
- Feb 2024
- First submitted
- 12 Mar 2015
- Last updated
- 21 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ring A, Sutherland S, Harper-Wynne C, Owen J, Sanglier T, Velikova G. A disease registry study to prospectively observe treatment patterns and outcomes in patients with HER2-positive unresectable LA/MBC: final results of the ESTHER study. Breast Cancer Res Treat. 2025 Jul;212(1):113-121. doi: 10.1007/s10549-025-07708-4. Epub 2025 May 13.
PubMed 40358647
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UK - A Disease Registry Study to Prospectively Observe Treatment Patterns and Outcomes in Patients With HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT02393924
- Acronym / sponsor ID
- ESTHER / ML29659
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 311 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 23 Feb 2015 (actual)
- Primary completion
- 19 Apr 2023 (actual)
- Study completion
- 19 Apr 2023 (actual)
- First posted
- 20 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants With HER2-Positive Breast Cancer | – | Other: No interventionEnrolled 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with HER2-positive unresectable LABC or mBC
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- There are no exclusion criteria for entry into this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention | Other | Participants With HER2-Positive Breast Cancer |
Primary outcome
Percentage of Participants Receiving Each Unique Treatment Regimen Overall
Time frame: 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
Percentage of Participants Receiving Each Unique Treatment Regimen Sequence
Time frame: 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.
16 secondary outcomes
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)
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)
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)
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)
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)
Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Time frame: Baseline up to approximately 8 years
Percentage of Participants by Reasons for Treatment Modification
Time frame: Baseline up to approximately 8 years
Percentage of Participants Receiving Each Treatment Regimen Categorized by Participant Characteristics
Time frame: Baseline up to approximately 8 years
Number of Treatment Regimens Received
Time frame: 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)
Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire Score
Time frame: 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)
Percentage of Participants with Different Anti-Cancer Treatment Regimens by Country
Time frame: 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
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)
Percentage of Participants with Oligometastatic Disease Categorized by Different Anti-Cancer Treatment Regimens
Time frame: Baseline up to approximately 8 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Derived from this study: PubMed 40358647Ring A, Sutherland S, Harper-Wynne C, Owen J, Sanglier T, Velikova G. A disease registry study to prospectively observe treatment patterns and outcomes in patients with HER2-positive unresectable LA/MBC: final results of the ESTHER study. Breast Cancer Res Treat. 2025 Jul;212(1):113-121. doi: 10.1007/s10549-025-07708-4. Epub 2025 May 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Hoffmann-La Roche at 30 sites in United Kingdom.
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 2 inclusion and 1 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 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United Kingdom. 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 Unique Treatment Regimen Overall (time frame: Baseline up to approximately 8 years). 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 NCT02393924, which also lists 1 linked publication.
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 21 Feb 2024.