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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04857619
Registration number
NCT04857619
Ethics application status
Date submitted
21/04/2021
Date registered
23/04/2021
Titles & IDs
Public title
Study to Describe the Real-world Treatment Patterns and Associated Outcomes in Patients With HER2-positive Unresectable or Metastatic Breast Cancer
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Scientific title
A Multicountry, Multicentre, Non-interventional, Retrospective Study to Describe the Real-world Treatment Patterns and Associated Outcomes in Patients With HER2-positive Unresectable or Metastatic Breast Cancer
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Secondary ID [1]
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D9673R00005
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metastatic Breast Cancer
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Other interventions - None (Observational study)
Retrospective - Patients who are diagnosed with HER2-positive unresectable or mBC and have received at least 1 LOT in the advanced setting will be included. Approximately a total of 570-830 patients will be enrolled in the study.
Other interventions: None (Observational study)
The data on different types of treatment received by the patients, socio-demographics, and clinico-pathological characteristics and healthcare resource utilisation will be extracted from patients' medical records (both alive and deceased).
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of patients receiving each treatment regimen with or without hormonal therapy in each LOT
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Assessment method [1]
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Assessment of treatment patterns in patients diagnosed with HER2-positive unresectable or mBC. Line of treatment (LOT) is defined as one regimen, possibly a combination of several drugs, given from either the index diagnosis or disease progression until the treatment fails to control the disease, is not tolerated by the patient, the disease relapses/progresses, or death occurs.
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Timepoint [1]
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Retrospective: from date of first diagnosis of unresectable or mBC (01 January 2017) to the end of follow-up (i.e., until death, the last medical record entry, or date of data extraction, whichever is the earliest) [Approximately 12 Months]
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Primary outcome [2]
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Duration of therapy (DoT) for each regimen in each LOT
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Assessment method [2]
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Assessment of length of time from initiation of therapy to permanent discontinuation. The DoT will be calculated as the time from the date of initiation of LOT to the stop of the treatment regimen for every LOT as per dates available in the medical record.
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Timepoint [2]
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Retrospective: from date of first diagnosis of unresectable or mBC (01 January 2017) to the end of follow-up (i.e., until death, the last medical record entry, or date of data extraction, whichever is the earliest) [Approximately 12 Months]
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Primary outcome [3]
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Percentage of patients receiving local and regional treatment for metastasis
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Assessment method [3]
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Assessment of local and regional treatment for metastasis (radiotherapy and/or surgery), and bone protection therapy
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Timepoint [3]
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Retrospective: from date of first diagnosis of unresectable or mBC (01 January 2017) to the end of follow-up (i.e., until death, the last medical record entry, or date of data extraction, whichever is the earliest) [Approximately 12 Months]
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Secondary outcome [1]
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Demographic and clinico-pathological characteristics of patients with HER2-positive unresectable or mBC
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Assessment method [1]
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Descriptive statistics will be used to describe socio-demographic and clinico-pathological characteristics for the overall study.
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Timepoint [1]
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Retrospective: from date of first diagnosis of unresectable or mBC (01 January 2017) to the end of follow-up (i.e., until death, the last medical record entry, or date of data extraction, whichever is the earliest) [Approximately 12 Months]
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Secondary outcome [2]
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Real-world disease progression
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Assessment method [2]
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Real-world disease progression of unresectable or mBC is defined as that documented in either the radiology report, pathology reports or clinician note as cancer progression.
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Timepoint [2]
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Retrospective: from date of first diagnosis of unresectable or mBC (01 January 2017) to the end of follow-up (i.e., until death, the last medical record entry, or date of data extraction, whichever is the earliest) [Approximately 12 Months]
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Secondary outcome [3]
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Real-world progression free survival (rwPFS)
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Assessment method [3]
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Real-world PFS is defined as the time from date of initiation of LOT to documented disease progression or death, whichever occurs first. Occurrence and date of disease progression in rwPFS will be determined from documentation within the patient record, such as pathology reports, imaging report notes, and statements about disease progression in the oncologist progress notes. Patients without an event (progression/death) will be censored at last date of assessment.
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Timepoint [3]
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Retrospective: from date of first diagnosis of unresectable or mBC (01 January 2017) to the end of follow-up (i.e., until death, the last medical record entry, or date of data extraction, whichever is the earliest) [Approximately 12 Months]
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Secondary outcome [4]
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Overall survival
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Assessment method [4]
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Length of time from the date of diagnosis of unresectable or mBC or date of initiation of LOT to death due to any cause. If patient is not dead until the last record available or date of data extraction, then time-to-event will be calculated for that date. Patients who are known to be alive at the date of data collection will be censored at the date of data collection. Patients who are lost to follow up will be censored on the date they were last known to be alive (eg. date of last recorded hospital visit).
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Timepoint [4]
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Retrospective: from date of first diagnosis of unresectable or mBC (01 January 2017) to the end of follow-up (i.e., until death, the last medical record entry, or date of data extraction, whichever is the earliest) [Approximately 12 Months]
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Secondary outcome [5]
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Real-world objective response rate
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Assessment method [5]
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The percentage of patients who have achieved real-world partial response (rwPR) and real-world complete response (rwCR) to therapy for each LOT.
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Timepoint [5]
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Retrospective: from date of first diagnosis of unresectable or mBC (01 January 2017) to the end of follow-up (i.e., until death, the last medical record entry, or date of data extraction, whichever is the earliest) [Approximately 12 Months]
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Secondary outcome [6]
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Real-world disease control rate
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Assessment method [6]
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The percentage of patients with rwCR, rwPR and real-world stable disease (rwSD) during treatment for each LOT
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Timepoint [6]
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Retrospective: from date of first diagnosis of unresectable or mBC (01 January 2017) to the end of follow-up (i.e., until death, the last medical record entry, or date of data extraction, whichever is the earliest) [Approximately 12 Months]
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Secondary outcome [7]
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Percentage of Proportion of patients with AESIs that led to treatment discontinuations, hospitalisatons and deaths.
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Assessment method [7]
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Assessment of safety and tolerability of different treatment regimens in patients with HER2-positive unresectable or mBC.
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Timepoint [7]
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Retrospective: from date of first diagnosis of unresectable or mBC (01 January 2017) to the end of follow-up (i.e., until death, the last medical record entry, or date of data extraction, whichever is the earliest) [Approximately 12 Months]
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Eligibility
Key inclusion criteria
* Adult female or male patients =18 years old or 'adults' according to the age of majority as defined by the local regulations
* Patient or next of kin/legal representative willing and able to provide written informed consent according to the local regulations unless a waiver is granted by the local IRB/IEC/EC
* Patients' medical records showing a diagnosis of HER2-positive unresectable or mBC (can be either de novo advanced disease, progression or recurrence of previous early-stage HER2-positive BC) since the available date of T-DM1 (Kadcyla) through reimbursement or patient access programme as a valid local treatment option or 01 January 2017, whichever is earlier and with the availability of at least 12 months of follow-up data (from the date of diagnosis of unresectable or mBC) in the medical records at the participating site, unless patient died within the first 12 months of diagnosis
* Patients completing at least 1 LOT for HER2-positive unresectable or mBC
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Patients with HER2-negative unresectable or mBC at index diagnosis
* Patients with a change in HER2 status from positive to negative at the progression from early-stage to advanced-stage disease (ie, shown on a repeat biopsy at diagnosis of advanced-stage disease) will be excluded (patients who change from HER2-positive to negative on repeat biopsy during treatment for advanced-stage disease may be included)
* Patients with concomitant cancer at the time of diagnosis of HER2-positive unresectable or mBC except for the non-metastatic non-melanoma skin cancers, or in situ, or benign neoplasms; a cancer is considered concomitant if it occurs within 5 years of HER2-positive breast cancer diagnosis
* Patients who at the time of data collection for this study are participating or have participated in an interventional study that remains blinded
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Study design
Purpose
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Duration
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Selection
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Timing
Retrospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
14/05/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/10/2022
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Sample size
Target
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Accrual to date
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Final
763
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Recruitment in Australia
Recruitment state(s)
NSW,WA
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Recruitment hospital [1]
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Research Site - Macquarie
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Recruitment hospital [2]
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Research Site - Newcastle
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Recruitment hospital [3]
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Research Site - Parramatta
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Recruitment hospital [4]
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Research Site - St Leonards
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Recruitment hospital [5]
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Research Site - Perth
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Recruitment postcode(s) [1]
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2109 - Macquarie
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Recruitment postcode(s) [2]
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2305 - Newcastle
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Recruitment postcode(s) [3]
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2145 - Parramatta
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Recruitment postcode(s) [4]
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2065 - St Leonards
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Recruitment postcode(s) [5]
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- Perth
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Recruitment outside Australia
Country [1]
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Brazil
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State/province [1]
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Amazonas
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Country [2]
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Brazil
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State/province [2]
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Bahia
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Country [3]
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Brazil
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State/province [3]
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Ceara
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Country [4]
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Brazil
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State/province [4]
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Espirito Santo
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Country [5]
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Brazil
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State/province [5]
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Parana
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Country [6]
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Brazil
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State/province [6]
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Rio Grande Do Sul
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Country [7]
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Brazil
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State/province [7]
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Santa Catarina
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Country [8]
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Brazil
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State/province [8]
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Sao Paulo
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Country [9]
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Brazil
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State/province [9]
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Fortaleza
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Country [10]
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Brazil
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State/province [10]
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Goiania
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Country [11]
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Brazil
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State/province [11]
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Rio de Janeiro
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Country [12]
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Hong Kong
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State/province [12]
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Hong Kong
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Country [13]
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Hong Kong
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State/province [13]
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Kowloon
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Country [14]
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Korea, Republic of
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State/province [14]
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Incheon Gwang Yeogsi
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Country [15]
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Korea, Republic of
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State/province [15]
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Seoul Teugbyeolsi
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Korea, Republic of
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State/province [16]
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Goyang
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Country [17]
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Korea, Republic of
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State/province [17]
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Seoul
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Country [18]
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Singapore
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State/province [18]
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Central Singapore
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Country [19]
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Singapore
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State/province [19]
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South East
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Country [20]
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Singapore
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State/province [20]
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Singapore
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Country [21]
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Taiwan
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State/province [21]
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Tainan
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Country [22]
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Taiwan
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State/province [22]
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Kaohsiung
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Country [23]
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Taiwan
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State/province [23]
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Taichung City
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Country [24]
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Taiwan
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State/province [24]
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Taichung
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Country [25]
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Taiwan
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State/province [25]
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Taipei
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Address
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Country
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Parexel
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
This multicountry, multicenter, retrospective, non-interventional study involving patients diagnosed with HER2-positive unresectable or metastatic breast cancer mBC will be conducted to understand the demographic and clinico-pathological profile of the patients, diagnostic practices for human epidermal growth factor receptor 2 (HER2) status, current treatment landscape and sequencing of therapies, associated burden of toxicities with all lines of treatment (LOTs), and survival outcomes in the real-world setting.
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Trial website
https://clinicaltrials.gov/study/NCT04857619
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at:
https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure.
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Available to whom?
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at:
https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04857619