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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04857619




Registration number
NCT04857619
Ethics application status
Date submitted
21/04/2021
Date registered
23/04/2021
Date last updated
29/11/2022

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
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
Secondary ID [1] 0 0
D9673R00005
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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).
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of patients receiving each treatment regimen with or without hormonal therapy in each LOT
Timepoint [1] 0 0
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]
Primary outcome [2] 0 0
Duration of therapy (DoT) for each regimen in each LOT
Timepoint [2] 0 0
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]
Primary outcome [3] 0 0
Percentage of patients receiving local and regional treatment for metastasis
Timepoint [3] 0 0
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]
Secondary outcome [1] 0 0
Demographic and clinico-pathological characteristics of patients with HER2-positive unresectable or mBC
Timepoint [1] 0 0
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]
Secondary outcome [2] 0 0
Real-world disease progression
Timepoint [2] 0 0
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]
Secondary outcome [3] 0 0
Real-world progression free survival (rwPFS)
Timepoint [3] 0 0
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]
Secondary outcome [4] 0 0
Overall survival
Timepoint [4] 0 0
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]
Secondary outcome [5] 0 0
Real-world objective response rate
Timepoint [5] 0 0
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]
Secondary outcome [6] 0 0
Real-world disease control rate
Timepoint [6] 0 0
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]
Secondary outcome [7] 0 0
Percentage of Proportion of patients with AESIs that led to treatment discontinuations, hospitalisatons and deaths.
Timepoint [7] 0 0
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]

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
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/10/2022
Sample size
Target
Accrual to date
Final
763
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
Research Site - Macquarie
Recruitment hospital [2] 0 0
Research Site - Newcastle
Recruitment hospital [3] 0 0
Research Site - Parramatta
Recruitment hospital [4] 0 0
Research Site - St Leonards
Recruitment hospital [5] 0 0
Research Site - Perth
Recruitment postcode(s) [1] 0 0
2109 - Macquarie
Recruitment postcode(s) [2] 0 0
2305 - Newcastle
Recruitment postcode(s) [3] 0 0
2145 - Parramatta
Recruitment postcode(s) [4] 0 0
2065 - St Leonards
Recruitment postcode(s) [5] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
Amazonas
Country [2] 0 0
Brazil
State/province [2] 0 0
Bahia
Country [3] 0 0
Brazil
State/province [3] 0 0
Ceara
Country [4] 0 0
Brazil
State/province [4] 0 0
Espirito Santo
Country [5] 0 0
Brazil
State/province [5] 0 0
Parana
Country [6] 0 0
Brazil
State/province [6] 0 0
Rio Grande Do Sul
Country [7] 0 0
Brazil
State/province [7] 0 0
Santa Catarina
Country [8] 0 0
Brazil
State/province [8] 0 0
Sao Paulo
Country [9] 0 0
Brazil
State/province [9] 0 0
Fortaleza
Country [10] 0 0
Brazil
State/province [10] 0 0
Goiania
Country [11] 0 0
Brazil
State/province [11] 0 0
Rio de Janeiro
Country [12] 0 0
Hong Kong
State/province [12] 0 0
Hong Kong
Country [13] 0 0
Hong Kong
State/province [13] 0 0
Kowloon
Country [14] 0 0
Korea, Republic of
State/province [14] 0 0
Incheon Gwang Yeogsi
Country [15] 0 0
Korea, Republic of
State/province [15] 0 0
Seoul Teugbyeolsi
Country [16] 0 0
Korea, Republic of
State/province [16] 0 0
Goyang
Country [17] 0 0
Korea, Republic of
State/province [17] 0 0
Seoul
Country [18] 0 0
Singapore
State/province [18] 0 0
Central Singapore
Country [19] 0 0
Singapore
State/province [19] 0 0
South East
Country [20] 0 0
Singapore
State/province [20] 0 0
Singapore
Country [21] 0 0
Taiwan
State/province [21] 0 0
Tainan
Country [22] 0 0
Taiwan
State/province [22] 0 0
Kaohsiung
Country [23] 0 0
Taiwan
State/province [23] 0 0
Taichung City
Country [24] 0 0
Taiwan
State/province [24] 0 0
Taichung
Country [25] 0 0
Taiwan
State/province [25] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Parexel
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04857619
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries