None listed
Conditions
Brief summary
This is a multi-centre prospective cohort study to collect data related to the management of metastatic triple negative breast cancer (TNBC) in a routine clinical practice patient population, Who is it for? Patients of any age, gender and ECOG performance status diagnosed with metastatic, or inoperable TNBC (either relapsed or newly diagnosed metastatic disease), after 1st July 2018. Study details It is intended to collect real world data on the duration of therapy, the rationale for any change in treatment and uptake of targeted therapies or immunotherapy. This study will also collect comprehensive data on any treatment received in the (neo) adjuvant setting given that the type of chemotherapy regimen selected often impacts on treatment decisions in the metastatic setting. Where applicable, data on trimodality treatment of primary breast cancer and metastatic disease will also be recorded. Patients will not be required to do anything extra, we will just be collecting, demographics (age, any other diseases you have, how well you feel) whether you have had a test to check any gene mutations, like BRCA, where your cancer has spread to and any treatment information (chemotherapy, surgery, radiotherapy). This study will give us real life information about how various chemotherapy and other treatments are used in patients with advanced TNBC in routine practice in terms of when and in what combination, and how these variations in practice might influence patient outcomes.
Interventions
Triple negative breast cancers (TNBCs) account for approximately 15-20% of new breast cancer diagnoses. They are characterised by a lack of oestrogen, progesterone and human epidermal growth factor receptor 2 (HER2) receptor expression and mostly comprise the basal-like molecular subtype, although substantial heterogeneity exists within TNBCs. Clinically, TNBCs typically exhibit an aggressive phenotype and are associated with a higher risk of relapse within the first two years of diagnosis of ea
Triple negative breast cancers (TNBCs) account for approximately 15-20% of new breast cancer diagnoses. They are characterised by a lack of oestrogen, progesterone and human epidermal growth factor receptor 2 (HER2) receptor expression and mostly comprise the basal-like molecular subtype, although substantial heterogeneity exists within TNBCs. Clinically, TNBCs typically exhibit an aggressive phenotype and are associated with a higher risk of relapse within the first two years of diagnosis of early breast cancer. This is observed even though patients with early stage TNBC appear to derive greater proportional benefits from systemic chemotherapy than patients with ER-positive early stage breast cancer. Patients with advanced TNBC have a poorer prognosis compared to patients with other breast cancer subtypes (Reddy et al, 2018) in terms of both breast cancer specific survival and overall survival (OS), with a median OS of approximately 16 months. Treatment standards that guide the management of breast cancer in clinical practice are typically defined in prospective clinical trials. However, the selected patients who are enrolled in such clinical trials often differ from patients seen in a routine practice setting, with elderly breast cancer patients significantly underrepresented in the study population, and patients with ECOG performance status of two or higher are also excluded. Thus, the translation of data for emerging breast cancer therapies to a general patient population is challenging. There is also a paucity of data relating to how various chemotherapy agents are utilised in patients with advanced TNBC in routine practice in terms of sequencing and combination, and how these variations in practice might influence patient outcomes. This study will enable collection of real world data of patients with newly diagnosed advanced TNBC to improve understanding of the presentation, disease outcomes and treatment decisions made in the real world setting. Participants will not be required to have any extra tests or procedures, there will be no involvement from them just an audit of their records.
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 of any age, gender and ECOG performance status diagnosed with metastatic, or inoperable TNBC (either relapsed or de novo metastatic), after 1st July 2018. 2. Histological or cytological confirmation of TNBC [defined as absence of HER2, ER and progesterone receptor (PR) expression] from either the primary archival tissue or from biopsy material obtained from a metastatic site. ER and PR negativity are defined as <1% of cells expressing hormonal receptors via immunohistochemistry (IHC) analysis HER2 negativity by local laboratory assessment
Exclusion criteria
None
Outcome results
None listed