Clinical trial NCT02393924: Human Epidermal Growth Factor Receptor 2 (HER2) Positive Unresectable Locally Advanced or Metastatic Breast Cancer Disease Registry 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-03-20
Enrollment: 311
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with HER2-positive unresectable LABC or mBC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Receiving Each Unique Treatment Regimen Overall
timeFrame: Baseline up to approximately 8 years
measure: Percentage of Participants Receiving Each Unique Treatment Regimen as First-Line Versus Subsequent-Line Therapy
timeFrame: Baseline up to approximately 8 years
measure: Percentage of Participants Receiving Each Unique Treatment Regimen Sequence
timeFrame: Baseline up to approximately 8 years
measure: Progression-Free Survival
timeFrame: From start date of anti-cancer treatment regimen to the date of either disease progression or death (up to approximately 8 years)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: From the date of initiation of treatment to the date of death from any cause (up to approximately 8 years)
measure: Percentage of Participants With Objective Response of Complete Response (CR) or Partial Response (PR)
timeFrame: From the date of initiation of treatment to the date of disease progression or death from any cause (up to approximately 8 years)
measure: Duration of Response (DoR)
timeFrame: From date of first response (CR or PR) to the date of disease progression (up to approximately 8 years)
measure: Time to Treatment Failure
timeFrame: 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)
measure: Percentage of Participants With Central Nervous System (CNS) as First Site of Progression
timeFrame: From the date of initiation of treatment to the date of disease progression or death from any cause (up to approximately 8 years)
measure: Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
timeFrame: Baseline up to approximately 8 years
measure: Percentage of Participants by Reasons for Treatment Modification
timeFrame: Baseline up to approximately 8 years
measure: Percentage of Participants Receiving Each Treatment Regimen Categorized by Participant Characteristics
timeFrame: Baseline up to approximately 8 years
measure: Number of Treatment Regimens Received
timeFrame: Baseline up to approximately 8 years
measure: Euro Quality of Life 5-Dimension Questionnaire (EQ-5D) Score
timeFrame: Baseline up to approximately 8 years (assessed every 3 months)
measure: Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire Score
timeFrame: Baseline up to approximately 8 years (assessed every 3 months)
measure: Work Productivity and Activity Impairment (WPAI) Questionnaire Score
timeFrame: Baseline up to approximately 8 years (assessed every 3 months)
measure: Percentage of Participants with Different Anti-Cancer Treatment Regimens by Country
timeFrame: Baseline up to approximately 8 years
measure: Percentage of Participants with History of Breast Cancer by Different Anti-Cancer Treatment Regimens
timeFrame: Baseline up to approximately 8 years
measure: Percentage of Participants with CNS-only Disease Progression
timeFrame: From the date of initiation of treatment to the date of disease progression or death from any cause (up to approximately 8 years)
measure: Percentage of Participants with Oligometastatic Disease Categorized by Different Anti-Cancer Treatment Regimens
timeFrame: Baseline up to approximately 8 years
Other outcomes:
Locations:
city: Canterbury
country: United Kingdom
facility: Kent & Canterbury Hospital
city: Chesterfield
country: United Kingdom
facility: Chesterfield Royal Hospital
city: Cornwall
country: United Kingdom
facility: Royal Cornwall Hospital; Dept of Clinical Oncology
city: Cottingham
country: United Kingdom
facility: Castle Hill Hospital; The Queens Centre for Oncology and Haematology
city: East Kilbride
country: United Kingdom
facility: Hairmyres Hospital; Oncology Dept
city: Gateshead
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Inverness
country: United Kingdom
facility: Raigmore Hospital
city: Larbert
country: United Kingdom
facility: Forth Valley Royal Hospital ; Oncology Department
city: London
country: United Kingdom
facility: Queen Elizabeth Hospital
city: London
country: United Kingdom
facility: Royal Marsden Hospital; Dept of Med-Onc
city: London
country: United Kingdom
facility: Charing Cross Hospital; Medical Oncology.
city: Macclesfield
country: United Kingdom
facility: Macclesfield District General Hospital
city: Maidstone
country: United Kingdom
facility: Maidstone Hospital; Kent Oncology Centre
city: Manchester
country: United Kingdom
facility: Christie Hospital Nhs Trust; Medical Oncology
city: Middlesbrough
country: United Kingdom
facility: James Cook University Hospital; Oncology and Radiology
city: Northampton
country: United Kingdom
facility: Northampton General Hospital NHS Trust;Oncology Unit
city: Northwood
country: United Kingdom
facility: Mount Vernon & Watford Trust Hospital; Dept. of Clinical Oncology
city: Norwich
country: United Kingdom
facility: Norfolk & Norwich University Hospital; Oncology Department
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital; Oncology
city: Plymouth
country: United Kingdom
facility: Derriford Hospital; Plymouth Oncology Centre
city: Preston
country: United Kingdom
facility: Royal Preston Hosp; Rosemere Cancer Ctr
city: Rhyl
country: United Kingdom
facility: North Wales Cancer Treatment Centre, Glan Clwyd Hospital
city: Scarborough
country: United Kingdom
facility: Scarborough General Hospital
city: Shrewsbury
country: United Kingdom
facility: Royal Shrewsbury Hospitals Nhs Trust; Oncology
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital; Dept of Medical Oncology
city: Swansea
country: United Kingdom
facility: Singleton Hospital; Pharmacy
city: Swindon
country: United Kingdom
facility: Great Western Hospital, Swindon Cancer Research Unit; Osprey Unit Level 3
city: Wakefield
country: United Kingdom
facility: Pinderfields Hospital; Clinical Research Team, Rowan House
city: Yeovil
country: United Kingdom
facility: Yeovil District Hospital; Macmillan Unit
city: York
country: United Kingdom
facility: Airedale General Hospital; Oncology
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: