None listed
Conditions
Brief summary
This is a multi-centre prospective cohort study to collect data related to management of Hormone Receptor positive, HER2 negative advanced breast cancer in a real-world patient population. Who is it for? You may be elgible for this study if you are aged 18 years or older, of any gender and you have been diagnosed with metastatic, or inoperable histologically confirmed HR+, HER2- breast cancer (either metastatic at diagnosis or relapsed), after 1st January 2020. Study details All enrolled participants will contribute health data to the development of the registry. Participants will not have to attend additional appointments or undergo additional blood tests or scans outside of their routine treatment. Information collected from participants will include duration of therapy, the rationale for any change in treatment and uptake of targeted therapies or immunotherapy. This study will also collect data on any treatment received in the (neo) adjuvant setting, including chemotherapy and endocrine therapy as this does impact subsequent treatment decisions and treatment order in the metastatic setting. It is hoped this research will contribute important information about all patients with HR+, HER2- advanced breast cancer and help to inform future treatment decision-making for clinicians.
Interventions
To prospectively describe real-world clinicopathologic presentation and treatment selection in patients with newly or recently diagnosed HR+ve, HER2-ve Advanced Breast Cancer in Australia of approximately 300 patients from 10-15 sites. Recruitment is expected to take place over a 3 year period. The entire study duration is 4 years, with an estimated median patient follow up of 2.5 years.
There is no active participation of patients required as data will be collected from medical records. Informa
To prospectively describe real-world clinicopathologic presentation and treatment selection in patients with newly or recently diagnosed HR+ve, HER2-ve Advanced Breast Cancer in Australia of approximately 300 patients from 10-15 sites. Recruitment is expected to take place over a 3 year period. The entire study duration is 4 years, with an estimated median patient follow up of 2.5 years. There is no active participation of patients required as data will be collected from medical records. Information collected would include details about the presentation and course of disease, the type and sequence of therapies and the outcomes for each patient. The data would be collected retrospectively from January 2020 onward and prospectively for new patients and data.
Sponsors
The Walter and Eliza Hall Institute of Medical research (WEHI)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1.Patients aged 18, of any gender and ECOG performance status diagnosed with advanced HR+, HER2- breast cancer (either de novo metastatic or relapsed), after 1st January 2020 2.Histological or cytological confirmation of HR+, HER2- breast cancer from either primary archival tissue or from biopsy material obtained from a metastatic site a) Hormone receptor positivity is defined as greater than 1% of oestrogen receptor expression and/or greater than 1% of progesterone receptor expression via immunohistochemistry (IHC) analysis b) HER2 negativity by local laboratory assessment is defined as: - In situ hybridisation (ISH) non-amplification (ratio of HER2 to CEP 17 < 2.0 or single probe average HER2 gene copy number < 4 signals/cell) OR - IHC 0 or IHC 1+ (as per ASCO 2018 HER2 pathology classification guidelines)
Exclusion criteria
Patient's under 18 who have either HR-ve or HER2 +ve breast cancer Patient's who have non metastatic breast cancer
Outcome results
None listed