None listed
Conditions
Brief summary
The TRodelvy use in AdvanCed TrIple Negative BrEast Cancer in Australia also known as TRACIE aims to open at approximately 20 sites and include 150-200 patients. This is what is known as a non interventional study where we use patient data that has already been collected in the course of normal medical care. Who is it for: We are looking at adult patients, over 18 with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received at least two prior systemic therapies, including at least one prior therapy for locally advanced or metastatic disease, and who have started treatment with Trodelvy between 1 Oct 2021 and 30 September 2024 Health data that may be collected includes adverse events or side effects noted while receiving trodelvy, access to medical scans and/or blood tests used to determine disease progression/metastases and tumour characteristics identified during biopsy assessments. Participants will not be required to complete any physical assessments or have any visits or contact as part of this observational study. We already know that Trodelvy is safe and effective as a breast cancer treatment when used in clinical trials and hope to be able to show the same results in the real world setting.
Interventions
This is a secondary data use non-interventional study of patients in Australia who received Sacituzumab govitecan (Trodelvy), for the treatment of unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting. This study consists of two cohorts of patients: Expanded A
This is a secondary data use non-interventional study of patients in Australia who received Sacituzumab govitecan (Trodelvy), for the treatment of unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting. This study consists of two cohorts of patients: Expanded Access Program(EAP) patients who started SG from 1 Oct 2021 to 31 May 2022; and patients from the Pharmaceutical Benefits Scheme (PBS), who initiate Sacituzumab govitecan (Trodelvy) from 1 Jun 2022 until 30 September 2024. The duration of observation in each participant, e.g. patient medical data from each participant collected every 3months from start of SG treatment until study ends in August 2026.,This study uses secondary data collection only from patients medical records. The patients will be identified by the clinicians who treated them with SG and will not be required to provide any further information or test results.
Sponsors
Walter and Eliza Hall Institute
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with metastatic, or inoperable, locally advanced TNBC (either relapsed or de novo metastatic) 2. Patients who started SG during the patient identification period according to the locally approved indication: “Treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received at least two prior systemic therapies, including at least one prior therapy for locally advanced or metastatic disease”
Exclusion criteria
1. Patients participating in any interventional clinical trials during SG treatment 2. History of SG use prior to first administration for advanced TNBC
Outcome results
None listed