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

Breast Cancer Clinical Trial

— ESTHER  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02393924
• Other study ID #: ML29659
• Status: Completed
• Start date: February 23, 2015
• Est. completion date: April 19, 2023

Study information

• Verified date: February 2024
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 describe the clinical outcome for each treatment regimen measured as progression-free survival.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 311
• Est. completion date: April 19, 2023
• Est. primary completion date: April 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• No intervention

Locations

Country	Name	City	State
United Kingdom	Kent & Canterbury Hospital	Canterbury
United Kingdom	Chesterfield Royal Hospital	Chesterfield
United Kingdom	Royal Cornwall Hospital; Dept of Clinical Oncology	Cornwall
United Kingdom	Castle Hill Hospital; The Queens Centre for Oncology and Haematology	Cottingham
United Kingdom	Hairmyres Hospital; Oncology Dept	East Kilbride
United Kingdom	Queen Elizabeth Hospital	Gateshead
United Kingdom	Raigmore Hospital	Inverness
United Kingdom	Forth Valley Royal Hospital ; Oncology Department	Larbert
United Kingdom	Charing Cross Hospital; Medical Oncology.	London
United Kingdom	Queen Elizabeth Hospital	London
United Kingdom	Royal Marsden Hospital; Dept of Med-Onc	London
United Kingdom	Macclesfield District General Hospital	Macclesfield
United Kingdom	Maidstone Hospital; Kent Oncology Centre	Maidstone
United Kingdom	Christie Hospital Nhs Trust; Medical Oncology	Manchester
United Kingdom	James Cook University Hospital; Oncology and Radiology	Middlesbrough
United Kingdom	Northampton General Hospital NHS Trust;Oncology Unit	Northampton
United Kingdom	Mount Vernon & Watford Trust Hospital; Dept. of Clinical Oncology	Northwood
United Kingdom	Norfolk & Norwich University Hospital; Oncology Department	Norwich
United Kingdom	Nottingham City Hospital; Oncology	Nottingham
United Kingdom	Derriford Hospital; Plymouth Oncology Centre	Plymouth
United Kingdom	Royal Preston Hosp; Rosemere Cancer Ctr	Preston
United Kingdom	North Wales Cancer Treatment Centre, Glan Clwyd Hospital	Rhyl
United Kingdom	Scarborough General Hospital	Scarborough
United Kingdom	Royal Shrewsbury Hospitals Nhs Trust; Oncology	Shrewsbury
United Kingdom	Royal Marsden Hospital; Dept of Medical Oncology	Sutton
United Kingdom	Singleton Hospital; Pharmacy	Swansea
United Kingdom	Great Western Hospital, Swindon Cancer Research Unit; Osprey Unit Level 3	Swindon
United Kingdom	Pinderfields Hospital; Clinical Research Team, Rowan House	Wakefield
United Kingdom	Yeovil District Hospital; Macmillan Unit	Yeovil
United Kingdom	Airedale General Hospital; Oncology	York

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Receiving Each Unique Treatment Regimen Overall		Baseline up to approximately 8 years
Primary	Percentage of Participants Receiving Each Unique Treatment Regimen as First-Line Versus Subsequent-Line Therapy		Baseline up to approximately 8 years
Primary	Percentage of Participants Receiving Each Unique Treatment Regimen Sequence		Baseline up to approximately 8 years
Primary	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.	From start date of anti-cancer treatment regimen to the date of either disease progression or death (up to approximately 8 years)
Secondary	Overall Survival (OS)		From the date of initiation of treatment to the date of death from any cause (up to approximately 8 years)
Secondary	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.	From the date of initiation of treatment to the date of disease progression or death from any cause (up to approximately 8 years)
Secondary	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.	From date of first response (CR or PR) to the date of disease progression (up to approximately 8 years)
Secondary	Time to Treatment Failure		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)
Secondary	Percentage of Participants With Central Nervous System (CNS) as First Site of Progression		From the date of initiation of treatment to the date of disease progression or death from any cause (up to approximately 8 years)
Secondary	Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)		Baseline up to approximately 8 years
Secondary	Percentage of Participants by Reasons for Treatment Modification		Baseline up to approximately 8 years
Secondary	Percentage of Participants Receiving Each Treatment Regimen Categorized by Participant Characteristics		Baseline up to approximately 8 years
Secondary	Number of Treatment Regimens Received		Baseline up to approximately 8 years
Secondary	Euro Quality of Life 5-Dimension Questionnaire (EQ-5D) Score		Baseline up to approximately 8 years (assessed every 3 months)
Secondary	Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire Score		Baseline up to approximately 8 years (assessed every 3 months)
Secondary	Work Productivity and Activity Impairment (WPAI) Questionnaire Score		Baseline up to approximately 8 years (assessed every 3 months)
Secondary	Percentage of Participants with Different Anti-Cancer Treatment Regimens by Country		Baseline up to approximately 8 years
Secondary	Percentage of Participants with History of Breast Cancer by Different Anti-Cancer Treatment Regimens		Baseline up to approximately 8 years
Secondary	Percentage of Participants with CNS-only Disease Progression		From the date of initiation of treatment to the date of disease progression or death from any cause (up to approximately 8 years)
Secondary	Percentage of Participants with Oligometastatic Disease Categorized by Different Anti-Cancer Treatment Regimens		Baseline up to approximately 8 years