Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000671561p
Ethics application status
Submitted, not yet approved
Date submitted
19/04/2024
Date registered
27/05/2024
Date last updated
27/05/2024
Date data sharing statement initially provided
27/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
KATRINA: Pembrolizumab (KeytrudA) in early Triple Negative breast cancer in Australia
Scientific title
KATRINA: Pembrolizumab (KeytrudA) in early Triple Negative breast cancer in routine clinical practice patient population in Australia
Secondary ID [1] 312000 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
early breast cancer 333610 0
triple negative breast cancer 333611 0
Condition category
Condition code
Cancer 330297 330297 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
KATRINA is a multicentre, retrospective cohort study aiming to collect data related to patient and disease characteristics, treatment patterns and outcomes of early triple negative breast cancer in a routine clinical practice patient population, who have received pembrolizumab in the neoadjuvant setting via a medicine access program or reimbursed supply in Australia.

There is no direct involvement of patients in this study. The study is collecting data retrospectively from medical records. Patients will not be asked to complete any assessments for the study that is outside routine clinical practice. The total duration of the study is 5 years (June 2024 to June 2028), allowing for a median follow up period of 3.5 years
Intervention code [1] 328455 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338039 0
Rates of pathological complete response (pCR)
Timepoint [1] 338039 0
At time of definitive surgery after completion of neoadjuvant therapy
Primary outcome [2] 338040 0
3-year event-free survival (EFS)
Timepoint [2] 338040 0
At 3 years post commencement of neoadjuvant therapy
Secondary outcome [1] 434284 0
Treatment patterns including variations in neo(adjuvant) chemotherapy regimens
Timepoint [1] 434284 0
At any time during follow-up as per treating clinician's discretion, up to a maximum of 5 years post commencement of neoadjuvant therapy
Secondary outcome [2] 434285 0
Rates of prescription and completion of adjuvant pembrolizumab
Timepoint [2] 434285 0
At 7 months post surgery.
Secondary outcome [3] 434286 0
Incidence and reasons for early discontinuation of pembrolizumab
Timepoint [3] 434286 0
At 7 months post surgery.
Secondary outcome [4] 434287 0
Treatment patterns in patients who relapse following previous treatment with pembrolizumab in the early setting
Timepoint [4] 434287 0
At any time during follow-up as per treating clinician's discretion, up to a maximum of 5 years post commencement of neoadjuvant therapy
Secondary outcome [5] 434288 0
Progression-free survival (PFS) for patients who develop advanced TNBC
Timepoint [5] 434288 0
At any time during follow-up as per treating clinician's discretion, up to a maximum of 5 years post commencement of neoadjuvant therapy
Secondary outcome [6] 434290 0
Overall survival
Timepoint [6] 434290 0
At any time during follow-up as per treating clinician's discretion, up to a maximum of 5 years post commencement of neoadjuvant therapy

Eligibility
Key inclusion criteria
• Patients of any age, gender and ECOG performance status with high risk, early stage TNBC who are enrolled in the pembrolizumab access program or accessed pembrolizumab via the PBS are eligible for enrolment to the study.
• Patients must receive at least one dose of neoadjuvant pembrolizumab
• Note patients who have a non-active 2nd primary malignancy not currently receiving active treatment can be included.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients who have not received any pembrolizumab or only received pembrolizumab in the adjuvant setting are not eligible for this study.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/05/2024
Actual
Date of last participant enrolment
Anticipated
30/05/2026
Actual
Date of last data collection
Anticipated
30/05/2026
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 316344 0
Commercial sector/Industry
Name [1] 316344 0
Merck Sharp & Dohme
Country [1] 316344 0
Australia
Primary sponsor type
University
Name
Walter and Eliza Hall Institute
Address
Country
Australia
Secondary sponsor category [1] 318533 0
None
Name [1] 318533 0
None
Address [1] 318533 0
Country [1] 318533 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315155 0
The Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 315155 0
https://www.thermh.org.au/research/researchers/ethics
Ethics committee country [1] 315155 0
Australia
Date submitted for ethics approval [1] 315155 0
02/04/2024
Approval date [1] 315155 0
Ethics approval number [1] 315155 0

Summary
Brief summary
This study aims to collect data related to patient and disease characteristics, treatment patterns and outcomes of early triple negative breast cancer (TNBC) patients, who have received pembrolizumab in the neoadjuvant setting via a medicine access program or reimbursed supply in Australia.

Who is it for?
You may be eligible for this study if you a patient of any age, gender with high risk, early stage TNBC who are enrolled in the pembrolizumab access program or accessed pembrolizumab via the PBS are eligible for enrolment to the study.

You will not be required to undergo any additional tests or assessments for this study. We will be collecting your data captured as part of routine care from medical records.

The study will enable collection of comprehensive, real-world data of patients with early triple negative breast cancer receiving pembrolizumab to improve understanding of the disease presentation, treatment patterns and patient outcomes in routine clinical practice in Australia.

The protocol and relevant supporting information will be submitted to Human Research Ethics Committees (HREC) and/or the respective Research Governance Officer (RGO; if required) and approved by the HREC and/or the respective RGO before the study is initiated.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133846 0
Dr Sheau Wen Lok
Address 133846 0
1G, Walter and Eliza Hall Institute/1G Royal Parade, Parkville VIC 3052
Country 133846 0
Australia
Phone 133846 0
+61 3 9345 2555
Fax 133846 0
Email 133846 0
SheauWen.Lok@petermac.org
Contact person for public queries
Name 133847 0
Sheau Wen Lok
Address 133847 0
1G, Walter and Eliza Hall Institute/1G Royal Parade, Parkville VIC 3052
Country 133847 0
Australia
Phone 133847 0
+61 3 9345 2555
Fax 133847 0
Email 133847 0
SheauWen.Lok@petermac.org
Contact person for scientific queries
Name 133848 0
Sheau Wen Lok
Address 133848 0
1G, Walter and Eliza Hall Institute/1G Royal Parade, Parkville VIC 3052
Country 133848 0
Australia
Phone 133848 0
+61 3 9345 2555
Fax 133848 0
Email 133848 0
SheauWen.Lok@petermac.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.