Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001138178
Ethics application status
Approved
Date submitted
6/06/2019
Date registered
15/08/2019
Date last updated
15/08/2019
Date data sharing statement initially provided
15/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Kisqali Access Registry for Metastatic Breast Cancer in Australia
Scientific title
Kisqali Access Registry for Metastatic Breast Cancer in Australia
Secondary ID [1] 298437 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
KARMA
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 313173 0
Condition category
Condition code
Cancer 311633 311633 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
1
Target follow-up type
Years
Description of intervention(s) / exposure
This is a secondary data use non interventional study of patients with hormone receptor positive HER2 negative metatstatic breast cancer who received treatment with the combination of ribociclib and an aromatase inhibitor. The ribociclib was obtained through either the MAP or SPARK program and the data will be retrieved by chart review.
Patients data will be collected at 2 timepoints, first between July and September 2019 and then again 12 months later
Intervention code [1] 314683 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320330 0
Real world clinical and tumour characteristics, and treatment description of patients with HR+ HER2–ve MBC in Australia who have received ribociclib in combination with an aromatase inhibitor as part of the ribociclib MAP and/or SPARK access program. Assessed by entry into medical records.
Timepoint [1] 320330 0
1) At enrolment/baseline
2) 12 months post enrolment
Secondary outcome [1] 371265 0
• Duration of treatment with ribociclib + AI in the first line setting for patients with HR+ HER2-ve MBC assessed by entry into medical record.
Timepoint [1] 371265 0
1) At enrolment/baseline
2) 12 months post enrolment
Secondary outcome [2] 371748 0
• Progression free survival (PFS) measured from the date of commencement of treatment with the combination of ribociclib and AI until disease progression or death prior to progression from any cause. Assessed by entry into medical records.
Timepoint [2] 371748 0
1) At enrolment/baseline
2) 12 months post enrolment
Secondary outcome [3] 371751 0
Patterns of disease progression post first line treatment with ribociclib and AI including sites of metastatic disease, and choice of subsequent therapy up to a maximum of two further lines of systemic treatment. Assessed by entry into medical records.
As per protocol this is a composite secondary outcome.
Timepoint [3] 371751 0
1) At enrolment/baseline
2) 12 months post enrolment
Secondary outcome [4] 371752 0

• PFS of immediate line of therapy post AI + ribociclib (where applicable) Assessed by entry into medical records.
Timepoint [4] 371752 0
1) At enrolment/baseline
2) 12 months post enrolment

Eligibility
Key inclusion criteria
Patients who meet the following inclusion criteria are eligible for the study:
• Age is 18 or over
• Patients with metastatic or advanced HR positive, HER2 –ve breast cancer who have received combination treatment with ribociclib and an aromatase inhibitor as part of the Novartis ribociclib MAP/SPARK program between the period of 1 May 2017 to 30 June 2018
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who have opted out of data collection will be excluded from the study.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
Time to event endpoints (PFS) are described using Kaplan-Meier methods with 95% confidence intervals. The stratified log rank test will be used to compare survival curves between different groups of participants. Comparison of specific variables will be performed using the Chi square method. P-values of 0.05 will be considered significant.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
25/07/2019
Date of last participant enrolment
Anticipated
31/12/2019
Actual
Date of last data collection
Anticipated
31/12/2020
Actual
Sample size
Target
250
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC
Recruitment hospital [1] 13948 0
Border Medical Oncology - Albury
Recruitment hospital [2] 13949 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [3] 13950 0
Bendigo Health Care Group - Bendigo Hospital - Bendigo
Recruitment hospital [4] 13951 0
The Canberra Hospital - Garran
Recruitment hospital [5] 13952 0
Icon Cancer Care South Brisbane - South Brisbane
Recruitment hospital [6] 13953 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [7] 13954 0
Liverpool Hospital - Liverpool
Recruitment hospital [8] 13955 0
Northern Cancer Institute - Frenchs Forest - Frenchs Forest
Recruitment hospital [9] 13956 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [10] 13957 0
Mater Sydney - North Sydney
Recruitment hospital [11] 13958 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [12] 13959 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [13] 13960 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 26723 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 26727 0
2060 - North Sydney
Recruitment postcode(s) [3] 26725 0
2086 - Frenchs Forest
Recruitment postcode(s) [4] 26724 0
2170 - Liverpool
Recruitment postcode(s) [5] 26721 0
2605 - Garran
Recruitment postcode(s) [6] 26718 0
2640 - Albury
Recruitment postcode(s) [7] 26726 0
3000 - Melbourne
Recruitment postcode(s) [8] 26719 0
3084 - Heidelberg
Recruitment postcode(s) [9] 26720 0
3550 - Bendigo
Recruitment postcode(s) [10] 26730 0
4029 - Herston
Recruitment postcode(s) [11] 26722 0
4101 - South Brisbane
Recruitment postcode(s) [12] 26728 0
4102 - Woolloongabba
Recruitment postcode(s) [13] 26729 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 302984 0
Commercial sector/Industry
Name [1] 302984 0
Norvartis
Country [1] 302984 0
Australia
Primary sponsor type
Other Collaborative groups
Name
The Walter and Eliza Hall Institute of Medical Research
Address
1G Royal Parade
Parkville
VIC 3052
Country
Australia
Secondary sponsor category [1] 302942 0
None
Name [1] 302942 0
Address [1] 302942 0
Country [1] 302942 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303535 0
Melbourne Health HREC
Ethics committee address [1] 303535 0
Level 2
South West
300 Grattan Street
Parkville Victoria 3050
Ethics committee country [1] 303535 0
Australia
Date submitted for ethics approval [1] 303535 0
30/04/2019
Approval date [1] 303535 0
05/06/2019
Ethics approval number [1] 303535 0
HREC/53367/MH-2019

Summary
Brief summary
The primary objective of the study is to describe real world clinical and tumour characteristics of patients with HR+ HER2–ve MBC in Australia who have received ribociclib in combination with an AI as part of the ribociclib MAP and/or SPARK access program, and treatment details of AI + ribociclib.

Who is it for?

You may be eligible to join this study if you are aged 18 years or above, and have been diagnosed with metastatic or advanced HR positive, HER2 –ve breast cancer, for which you have received combination treatment with ribociclib and an aromatase inhibitor as part of the Novartis ribociclib MAP/SPARK program between the period of 1 May 2017 to 30 June 2018.

Study Details

The information will be collected from the medical records of patients who were prescribed ribociclib in combination with an aromatase inhibitor as part of the ribociclib MAP and/or SPARK access program.
We hope that this information will give is an opportunity to improve our understanding of real world ribociclib treatment in Australia.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes
Nil

Contacts
Principal investigator
Name 93998 0
Dr Richard De Boer
Address 93998 0
Peter MacCallum Cancer Centre
Victorian Comprehensive Cancer Centre building
305 Grattan Street
Melbourne VIC 3000
Australia
Country 93998 0
Australia
Phone 93998 0
+61 38559 7422
Fax 93998 0
Email 93998 0
Richard.DeBoer@wh.org.au
Contact person for public queries
Name 93999 0
Dr Sheau Wen Lok
Address 93999 0
Peter MacCallum Cancer Centre
Victorian Comprehensive Cancer Centre building
305 Grattan Street
Melbourne VIC 3000
Australia
Country 93999 0
Australia
Phone 93999 0
+61 38559 7422
Fax 93999 0
Email 93999 0
SheauWen.Lok@petermac.org
Contact person for scientific queries
Name 94000 0
Dr Sheau Wen Lok
Address 94000 0
Peter MacCallum Cancer Centre
Victorian Comprehensive Cancer Centre building
305 Grattan Street
Melbourne VIC 3000
Australia
Country 94000 0
Australia
Phone 94000 0
+61 38559 7422
Fax 94000 0
Email 94000 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.