None listed
Conditions
Brief summary
This study will collect data related to the management of women and men with HER2 positive metastatic breast cancer who are treated in routine clinical practice. Who is it for? You may be eligible to join this study if you are a patient of any age and any level of fitness with HER2+ metastatic breast cancer, of any hormone receptor status, either recurrent or de novo metastatic disease, who has either been diagnosed with metastatic disease within the last 3-6 months or who has progressed on 1st line therapy in the last 3-6 months. Study details For all patients enrolled in this study, data will be collected on the types of anti-HER2 therapies and chemotherapies used, how long treatment is given for, reasons for any changes in treatment, the impact of anti-HER2 therapies on heart function, and how often certain parts of the body, including the brain, are affected by HER2+ metastatic breast cancer. No personal/identifying data will be collected. This study will help to improve our knowledge of the way that HER2+ metastatic breast cancer behaves, what types of treatment are effective, and the risks and benefits of these treatments within usual clinical practice conditions, with the aim of guiding future research of this disease and improving the outcomes for anyone affected by HER2+ metastatic breast cancer. All collected data will be compiled in a registry, which will be managed by BioGrid Australia. BioGrid Australia is a non-profit company that was set up to help with data collection and analyses for medical research.
Interventions
This is an observational/non-interventional study.
The factors to be observed include the type of clinical characteristics of participants, such as age at diagnosis, performance status, and comorbidities; the type of tumour characteristics such as rate of hormone receptor positivity, sites of metastatic disease at diagnosis, rate of brain metastases at any time during the disease course, and time to relapse in participants with past history of early stage breast cancer; treatment patterns includ
This is an observational/non-interventional study. The factors to be observed include the type of clinical characteristics of participants, such as age at diagnosis, performance status, and comorbidities; the type of tumour characteristics such as rate of hormone receptor positivity, sites of metastatic disease at diagnosis, rate of brain metastases at any time during the disease course, and time to relapse in participants with past history of early stage breast cancer; treatment patterns including the choice of HER2 agent for 1st, 2nd and 3rd line settings, choice of chemotherapy agent to be used in combination with HER2 therapy, and rate of treatment with trastuzumab beyond disease progression; and survival including overall survival and progression free survival in 1st, 2nd and 3rd line settings.
Sponsors
BioGrid Australia Ltd
Eligibility
Sex/Gender
All
Healthy volunteers
No
Inclusion criteria
Patients of any age and any level of fitness with HER2+ metastatic breast cancer, of any hormone receptor status, either recurrent or de novo metastatic disease, who have either been diagnosed with metastatic disease within the last 3-6 months or who have progressed on 1st line therapy in the last 3-6 months
Exclusion criteria
- Patients with HER2+ metastatic breast cancer who have received more than two lines of therapy already - Patients who are not Australian citizens or are otherwise ineligible for systemic treatment subsidised by the Pharmaceutical Benefit Scheme
Outcome results
None listed