Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000931673
Ethics application status
Approved
Date submitted
24/07/2023
Date registered
29/08/2023
Date last updated
29/08/2023
Date data sharing statement initially provided
29/08/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
TRodelvy use in AdvanCed TrIple Negative BrEast Cancer in Australia (TRACIE)
Scientific title
Evaluating the safety and efficacy of sacituzumab govitecan (SG) in patients with previously treated unresectable locally advanced or metastatic triple negative breast cancer (advanced TNB) through creation of a patient registry using secondary data.
Secondary ID [1] 309935 0
Nil known
Universal Trial Number (UTN)
Trial acronym
TRACIE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer only 330410 0
Condition category
Condition code
Cancer 327260 327260 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
3
Target follow-up type
Years
Description of intervention(s) / exposure
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.
Intervention code [1] 326360 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335734 0
Real World Progression Free Survival (rwPFS,) will be assessed using data collected according to routine medical practice through secondary data collection using eCRFs.
Timepoint [1] 335734 0
From the date of SG initiation until the latest recorded date (loss of follow-up) or end of August 2026, or death, whichever occurs first.
Secondary outcome [1] 423204 0
- To determine the duration of treatment of SG using patient medical records.
Timepoint [1] 423204 0
assessed 3 monthly from start of SG treatment until end of study in August 2026
Secondary outcome [2] 423205 0
- To evaluate the percentage of patients with at least one adverse event (AE) resulting in SG treatment discontinuation, SG dose reduction, and adverse events of special interest (AESI) including neutropenia, diarrhoea, pneumonitis and pneumonia as per medical records
Timepoint [2] 423205 0
assessed 3 monthly from start of SG treatment until end of study in August 2026
Secondary outcome [3] 423212 0
- To estimate real world overall survival (OS)
Timepoint [3] 423212 0
from diagnosis to end of August 2026
Secondary outcome [4] 423213 0
- To estimate time to next treatment from start of SG as per medical record
Timepoint [4] 423213 0
Assessed 3 monthly from start of SG treatment until end of study period in August 2026
Secondary outcome [5] 423214 0
- To compare real-world overall survival in patients with early (less than or equal to 12 months) vs. late (greater than 12 months) relapses following completion of (neo)adjuvant therapy for early stage TNBC as per medical records
Timepoint [5] 423214 0
Assessed 3 monthly from beginning of SG treatment until study end (end of August 2026)

Eligibility
Key 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”
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
28/08/2023
Date of last participant enrolment
Anticipated
30/09/2026
Actual
Date of last data collection
Anticipated
30/09/2026
Actual
Sample size
Target
200
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
Recruitment hospital [1] 24951 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 24952 0
Chris O’Brien Lifehouse - Camperdown
Recruitment hospital [3] 24953 0
Eastern Health - Box Hill
Recruitment hospital [4] 24954 0
Ballarat Health Services (Base Hospital) - Ballarat Central
Recruitment hospital [5] 24955 0
Icon Cancer Centre Hobart - Hobart
Recruitment hospital [6] 24956 0
Mater Sydney - North Sydney
Recruitment hospital [7] 24957 0
Peninsula Private Hospital - Frankston - Frankston
Recruitment hospital [8] 24958 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [9] 24959 0
St Vincent's Private Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [10] 24960 0
Warringal Private Hospital - Heidelberg
Recruitment hospital [11] 24961 0
Cabrini Hospital - Malvern - Malvern
Recruitment hospital [12] 24962 0
Icon Cancer Care Adelaide - Kurralta Park
Recruitment hospital [13] 24963 0
Icon Cancer Care Townsville - Hyde Park
Recruitment postcode(s) [1] 40611 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 40604 0
2050 - Camperdown
Recruitment postcode(s) [3] 40608 0
2060 - North Sydney
Recruitment postcode(s) [4] 40603 0
3084 - Heidelberg
Recruitment postcode(s) [5] 40605 0
3128 - Box Hill
Recruitment postcode(s) [6] 40612 0
3144 - Malvern
Recruitment postcode(s) [7] 40609 0
3199 - Frankston
Recruitment postcode(s) [8] 40606 0
3350 - Ballarat Central
Recruitment postcode(s) [9] 40610 0
4102 - Woolloongabba
Recruitment postcode(s) [10] 40614 0
4812 - Hyde Park
Recruitment postcode(s) [11] 40613 0
5037 - Kurralta Park
Recruitment postcode(s) [12] 40607 0
7000 - Hobart

Funding & Sponsors
Funding source category [1] 314115 0
Commercial sector/Industry
Name [1] 314115 0
Gilead Siences
Country [1] 314115 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Walter and Eliza Hall Institute
Address
The Walter and Eliza Hall Institute of Medical Research
1G Royal Parade, Parkville,
Victoria, Australia 3052
Country
Australia
Secondary sponsor category [1] 316029 0
None
Name [1] 316029 0
Address [1] 316029 0
Country [1] 316029 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313253 0
Melbourne Health
Ethics committee address [1] 313253 0
The RMH Parkville
Level 2 South West
300 Grattan St, Parkville, 3052 Victoria
Ethics committee country [1] 313253 0
Australia
Date submitted for ethics approval [1] 313253 0
16/06/2023
Approval date [1] 313253 0
24/07/2023
Ethics approval number [1] 313253 0
HREC/97502/MH-2023
Ethics committee name [2] 313604 0
Melbourne Health
Ethics committee address [2] 313604 0
P.O Box 2155
Parkville
VIC 3050
Ethics committee country [2] 313604 0
Australia
Date submitted for ethics approval [2] 313604 0
26/04/2023
Approval date [2] 313604 0
Ethics approval number [2] 313604 0
HREC/97502/MH-2023

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127486 0
Dr Sheau Wen Lok
Address 127486 0
The Walter and Eliza Hall Institute of Medical Research
1G Royal Parade, Parkville,
Victoria, Australia 3052
Country 127486 0
Australia
Phone 127486 0
+61 3 9345 2893
Fax 127486 0
Email 127486 0
SheauWen.Lok@petermac.org
Contact person for public queries
Name 127487 0
Ms catherine morton
Address 127487 0
The Walter and Eliza Hall Institute of Medical Research
1G Royal Parade, Parkville,
Victoria, Australia 3052
Country 127487 0
Australia
Phone 127487 0
+61 3 9345 2893
Fax 127487 0
Email 127487 0
catherine.morton2@mh.org.au
Contact person for scientific queries
Name 127488 0
Dr Sheau Wen Lok
Address 127488 0
The Walter and Eliza Hall Institute of Medical Research
1G Royal Parade, Parkville,
Victoria, Australia 3052
Country 127488 0
Australia
Phone 127488 0
+61 3 9345 2893
Fax 127488 0
Email 127488 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.