None listed
Conditions
Brief summary
This study aims to evaluate the long term cardiovascular risk factors associated with taking endocrine therapies in patients with oestrogen receptor positive breast cancer. Who is it for? You may be eligible to join this study if you are aged 50-85 years (post-menopausal) and going to commence endocrine therapy treatment for breast cancer for at least 12 months, Study details The study will run for 12 months to observe the potential effects of endocrine treatment on cardiovascular risk factors. The study will involve 3 visits to determine changes in body fat distribution, and other markers of cardiovascular health. Part of the study will involve questionnaires, fasting blood tests, body, liver and bone density scans, There will be an additional blood test done between visits 1 and 3. The results of this study will provide clinicians with a potential means of stratifying each breast cancer woman's cardiovascular risk, enabling delivery of personalised care. This project will also provide a platform for subsequent interventional studies to investigate the clinical impact of risk factor modification.
Interventions
The arm of interest is those undergoing endocrine therapy (aromatase inhibitor or tamoxifen). Exposure must be continuous for the 12 months duration of the study.
All participants will be observed over 3 study visits and will be followed up over a total duration of 12 months for the evaluation of the primary outcomes. Although the primary timepoint for outcomes is at 12 months, this is a longitudinal study and data will continue to collected beyond 12 months up to 10 years.
*Baseline visit/v
The arm of interest is those undergoing endocrine therapy (aromatase inhibitor or tamoxifen). Exposure must be continuous for the 12 months duration of the study. All participants will be observed over 3 study visits and will be followed up over a total duration of 12 months for the evaluation of the primary outcomes. Although the primary timepoint for outcomes is at 12 months, this is a longitudinal study and data will continue to collected beyond 12 months up to 10 years. *Baseline visit/visit 1: conducted either within 8 weeks prior to commencing endocrine therapy/within 8 weeks of having commenced endocrine therapy (for the arm of interest group) or within 8 weeks of the tissue diagnosis of breast cancer not requiring endocrine therapy/ductal carcinoma insitu/lobular carcinoma insitu/benign breast pathology (for the control group). -Consent to trial participation and consent to access to records -Quality of life questionnaire -Blood test -Medical and physical assessment -Fibroscan -EndoPAT peripheral arterial tone measurement -Total body composition and dual energy Xray absorptiometry scan -Step count assessment via pedometer *Visit 2: 6 months after baseline visit -Quality of life questionnaire -Blood test -Medical and physical assessment -Fibroscan (if baseline fibroscan showed evidence of fibrosis (>6kpa) or steatosis (CAP >300) -EndoPAT peripheral arterial tone measurement -Total body composition and dual energy Xray absorptiometry scan -Step count assessment via pedometer Visit 3: 12 months after baseline visit -Quality of life questionnaire -Blood test -Medical and physical assessment -Fibroscan -EndoPAT peripheral arterial tone measurement -Total body composition and dual energy Xray absorptiometry scan -Step count assessment via pedometer The dose, type and duration of endocrine therapy is personalised for each participant depending on their cancer type and stage, their comorbidities and risk factors, and their tolerance to side effects. This is a decision made between the treating oncologist and the patient in the oncology outpatients clinic. The oncologist tends to review treatment tolerance and response every 3 months. This is all part of routine care and would be happening regardless of enrolment in this study.
Sponsors
The Department of Medicine, Austin Hospital
Eligibility
Sex/Gender
All
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
-Non-metastatic breast cancer -Postmenopausal -Aged 50-85yrs -To commence endocrine therapy treatment intended for at least 12 months -ECOG less than or equal to 1 -Ability to consent for study and comply with the study protocol requirements
Exclusion criteria
-Previous exposure to endocrine therapy (greater than 8 weeks prior to recruitment) -If endocrine therapy stops or changes -Established type 2 diabetes mellitus -Continuous glucocorticoid therapy for less than or equal to 2 weeks within 6 months of study -Hormone replacement therapy within 3 months of study -Any disease which is likely to lead to serious illness or death within the study period
Outcome results
None listed