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

Completed

• Conditions: Breast Cancer
• Interventions: Other: No intervention

• Registration Number: NCT02393924
• Lead Sponsor: Hoffmann-La Roche

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-23
• Study First Submitted: 2015-03-12
• Study First Submitted QC: 2015-03-16
• Study First Posted: 2015-03-20
• Primary Completion: 2023-04-19
• Study Completion: 2023-04-19
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-20
• Last Update Posted: 2024-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 311

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

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Exclusion Criteria

• There are no exclusion criteria for entry into this study

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants With HER2-Positive Breast Cancer	No intervention	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Receiving Each Unique Treatment Regimen Overall	Baseline up to approximately 8 years
Percentage of Participants Receiving Each Unique Treatment Regimen Sequence	Baseline up to approximately 8 years
Progression-Free Survival	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.
Percentage of Participants Receiving Each Unique Treatment Regimen as First-Line Versus Subsequent-Line Therapy	Baseline up to approximately 8 years

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Objective Response of Complete Response (CR) or Partial Response (PR)	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.
Percentage of Participants by Reasons for Treatment Modification	Baseline up to approximately 8 years
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)
Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)	Baseline up to approximately 8 years
Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire Score	Baseline up to approximately 8 years (assessed every 3 months)
Work Productivity and Activity Impairment (WPAI) Questionnaire Score	Baseline up to approximately 8 years (assessed every 3 months)
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)
Percentage of Participants with Oligometastatic Disease Categorized by Different Anti-Cancer Treatment Regimens	Baseline up to approximately 8 years
Overall Survival (OS)	From the date of initiation of treatment to the date of death from any cause (up to approximately 8 years)
Duration of Response (DoR)	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.
Euro Quality of Life 5-Dimension Questionnaire (EQ-5D) Score	Baseline up to approximately 8 years (assessed every 3 months)
Percentage of Participants with Different Anti-Cancer Treatment Regimens by Country	Baseline up to approximately 8 years
Percentage of Participants with History of Breast Cancer by Different Anti-Cancer Treatment Regimens	Baseline up to approximately 8 years
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)
Percentage of Participants Receiving Each Treatment Regimen Categorized by Participant Characteristics	Baseline up to approximately 8 years
Number of Treatment Regimens Received	Baseline up to approximately 8 years

Trial Locations

Locations (29)

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; 🇬🇧 London, United Kingdom

Raigmore Hospital; 🇬🇧 Inverness, United Kingdom

Forth Valley Royal Hospital ; Oncology Department; 🇬🇧 Larbert, United Kingdom

Royal Marsden Hospital; Dept of Med-Onc; 🇬🇧 London, United Kingdom

Charing Cross Hospital; Medical Oncology.; 🇬🇧 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

Norfolk & Norwich University Hospital; Oncology Department; 🇬🇧 Norwich, United Kingdom

Mount Vernon & Watford Trust Hospital; Dept. of Clinical Oncology; 🇬🇧 Northwood, 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, United Kingdom

Northampton General Hospital NHS Trust;Oncology Unit; 🇬🇧 Northampton, United Kingdom