BREAST Registry
Bringing real world evidence to tackle breast cancer
Principal investigators
Dr Sheau Wen Lok
Breast and lower GI Medical Oncologist at Peter MacCallum Cancer Centre and a Cancer Genetics specialist at the Parkville and Austin Familial Cancer Centres. Dr Lok leads the breast tumour stream at the Personalised Oncology division at the Walter and Eliza Hall Institute where her current research interest is focused on harnessing real world evidence through multi-centre breast cancer registries to inform clinical practice.
In the past 10 years, breast cancer diagnoses in Australia have increased by 24%, partly due to improved screening and broad community education and awareness, making it the second most commonly diagnosed cancer in Australia.
Breast cancer has a devastating impact on our community as it is the most common cancer among women. Breast cancer kills more than 3300 Australians a year and one woman under the age of 40 is expected to die from it each week.
Breast cancer can be classified as early, locally advanced, or metastatic, and is further categorised by receptor status (hormone receptor positive, HER2-positive, or triple negative).
“What's unique about breast cancer is that it's not the one disease unlike some other types of cancers,” says Dr Sheau Wen Lok, the Principal Investigator for the BREAST registry. “There are traditionally three distinct subtypes of breast cancer, each with different prognoses and treatment options.”
For this reason, real world evidence about the efficacy of treatments, particularly when considered in the context of patient comorbidities and lifestyle factors, is an important complement to clinical trial data.
The BREAST database, developed by BioGrid, acts as a portal, bringing together three existing, independently approved standalone registries that aim to improve understanding of the treatment and outcomes of breast cancer patients, providing an important resource for researchers and clinicians.
“It’s really helpful to have the BioGrid team providing support at all stages of the development of BREAST and the sub registries,” says Dr Lok.
The three registries within BREAST are TABITHA (Treatment of Advanced Breast Cancer in the HER2 Positive Australian Patient), ARORA (Advanced Hormone Receptor Positive Breast Cancer Registry in Australia), and TRACIE (TRodelvy use in AdvanCed TrIple Negative BrEast Cancer in Australia).
"We started with TABITHA the metastatic HER2 Positive breast cancer registry. Over time we expanded to add on the other two common subtypes of breast cancer to establish ARORA to capture hormone sensitive metastatic breast cancer, and the most recent one being TRACIE, which is a metastatic triple negative breast cancer registry,” says Dr Lok.
The idea behind BREAST was that the three individual registries could be used as standalone data sets, or investigators may ultimately wish to utilise data from a combination of these registries to investigate questions relevant to all three subtypes.
TABITHA was developed by BioGrid and the team decided that the addition of two other related data sets would also benefit from BioGrid’s expertise.
When we moved from one database to three, the team at BioGrid were familiar with both the data sharing platform and the database functionality and could therefore quickly understand what we wanted to achieve. They helped us bring that to life.
Dr Lok
The data in all three registries is available for use for approved collaborative clinical audit and research projects via BioGrid’s data sharing platform and is already being accessed by clinicians Australia-wide at least 3 to 4 times a year.
“The aim of these registries is to provide real world evidence. Clinical trials are still the gold standard for investigating new treatments, but the clinical trial population is not necessarily the same as a real world population,” says Dr Lok. “The patients who are in front of you in clinic are often older. Many do not meet clinical trial criteria as they often have comorbidities that would exclude them from standard clinical trials.
“It’s extremely valuable to understand what actually happens to these patients in the real world, and how they respond to the drugs that have proven to be effective in clinical trials.”
TABITHA
(Treatment of Advanced Breast Cancer in the HER2 Positive Australian Patient)
Designed in partnership with oncology healthcare professionals, the TABITHA Clinical Registry is a registry designed for the collection and management of information relating to the diagnosis, treatment and outcomes of patients with HER2+ metastatic breast cancer.
This clinical registry is being used to support research into the Treatment of Advanced Breast Cancer in the HER2 Positive Australian Patient (TABITHA).
The TABITHA Clinical Registry enables the collection of a comprehensive dataset, including diagnosis, systemic therapy, toxicities, adverse events, disease progression and surgical management.
ARORA
(Advanced Hormone Receptor Positive Breast Cancer Registry in Australia)
ARORA is a secondary data use study of Australian patients with HR+ ABC (advanced hormone receptor positive breast cancer), capturing prospective data on patient characteristics, systemic therapy sequencing and treatment outcomes in routine clinical practice.
A key challenge in treating advanced hormone receptor positive breast cancer is determining the optimal sequencing of therapies, with a significant number of therapeutic options available.
Commenced in 2023, the ARORA registry will help researchers identify the results of different applications of those therapies, ultimately supporting clinicians in their personalisation of treatment for individual patients. Other than treatment outcomes, the registry also collects data on adverse events to determine treatment tolerability in the real world setting.
The study recruited around 450 patients from approximately 20 sites around Australia and is currently in the follow up phase.
TRACIE
(TRodelvy use in AdvanCed TrIple Negative BrEast Cancer in Australia)
TRACIE is a study established in August 2023 , 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).
This non-interventional study will collect data on patient and tumour characteristics, treatment patterns in the metastatic setting, adverse events related to SG and survival outcomes.
Around 20 sites are currently involved, representing 150 patients, with a final site in the process of coming on board.