None listed
Conditions
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.
Interventions
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. Pat
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
Sponsors
Walter and Eliza Hall Institute
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Exclusion criteria
• Patients who have not received any pembrolizumab or only received pembrolizumab in the adjuvant setting are not eligible for this study.
Outcome results
None listed