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

NCT ID: NCT02393924

Last Updated: 2024-02-21

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

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Recruitment Status

COMPLETED

Total Enrollment

311 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-23

Study Completion Date

2023-04-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No intervention

Intervention Type OTHER

Interventions

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No intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Kent & Canterbury Hospital

Canterbury, , United Kingdom

Site Status

Chesterfield Royal Hospital

Chesterfield, , United Kingdom

Site Status

Royal Cornwall Hospital; Dept of Clinical Oncology

Cornwall, , United Kingdom

Site Status

Castle Hill Hospital; The Queens Centre for Oncology and Haematology

Cottingham, , United Kingdom

Site Status

Hairmyres Hospital; Oncology Dept

East Kilbride, , United Kingdom

Site Status

Queen Elizabeth Hospital

Gateshead, , United Kingdom

Site Status

Raigmore Hospital

Inverness, , United Kingdom

Site Status

Forth Valley Royal Hospital ; Oncology Department

Larbert, , United Kingdom

Site Status

Queen Elizabeth Hospital

London, , United Kingdom

Site Status

Royal Marsden Hospital; Dept of Med-Onc

London, , United Kingdom

Site Status

Charing Cross Hospital; Medical Oncology.

London, , United Kingdom

Site Status

Macclesfield District General Hospital

Macclesfield, , United Kingdom

Site Status

Maidstone Hospital; Kent Oncology Centre

Maidstone, , United Kingdom

Site Status

Christie Hospital Nhs Trust; Medical Oncology

Manchester, , United Kingdom

Site Status

James Cook University Hospital; Oncology and Radiology

Middlesbrough, , United Kingdom

Site Status

Northampton General Hospital NHS Trust;Oncology Unit

Northampton, , United Kingdom

Site Status

Mount Vernon & Watford Trust Hospital; Dept. of Clinical Oncology

Northwood, , United Kingdom

Site Status

Norfolk & Norwich University Hospital; Oncology Department

Norwich, , United Kingdom

Site Status

Nottingham City Hospital; Oncology

Nottingham, , United Kingdom

Site Status

Derriford Hospital; Plymouth Oncology Centre

Plymouth, , United Kingdom

Site Status

Royal Preston Hosp; Rosemere Cancer Ctr

Preston, , United Kingdom

Site Status

North Wales Cancer Treatment Centre, Glan Clwyd Hospital

Rhyl, , United Kingdom

Site Status

Scarborough General Hospital

Scarborough, , United Kingdom

Site Status

Royal Shrewsbury Hospitals Nhs Trust; Oncology

Shrewsbury, , United Kingdom

Site Status

Royal Marsden Hospital; Dept of Medical Oncology

Sutton, , United Kingdom

Site Status

Singleton Hospital; Pharmacy

Swansea, , United Kingdom

Site Status

Great Western Hospital, Swindon Cancer Research Unit; Osprey Unit Level 3

Swindon, , United Kingdom

Site Status

Pinderfields Hospital; Clinical Research Team, Rowan House

Wakefield, , United Kingdom

Site Status

Yeovil District Hospital; Macmillan Unit

Yeovil, , United Kingdom

Site Status

Airedale General Hospital; Oncology

York, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 40358647 (View on PubMed)

Other Identifiers

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ML29659

Identifier Type: -

Identifier Source: org_study_id

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