None listed
Conditions
Brief summary
The EMT study is investigating a molecular process (epithelial-mesenchymal transition) which can occur in the breast cancer cells of some patients, which can make the cancer more aggressive and might reflect how well the cancer cells will respond to treatment. Who is it for? Eligible patients in this study are aged 18 years or older, have been diagnosed with hormone receptor positive, HER2 negative breast cancer and have received a cyclin D kinase inhibitor in the adjuvant setting and have experienced a breast cancer recurrent event, or have received a cyclin D kinase inhibitor for treatment of metastatic cancer. Any metastatic breast cancer patient who has received at least one dose of eribulin in the course of their treatment may also be eligible. Study details All participants enrolled in this study will be asked to provide 1-2 tumour biopsies (tissue samples) that will be used to perform the molecular tests to determine EMT activity. Samples from previous surgeries and/or biopsies may be used to perform the molecular tests. Some eligible participants may be asked to undergo a maximum of two new biopsies if tissue from prior procedures is not available. No other patient procedures will be performed. It is hoped this research will provide more information regarding the EMT process which may allow doctors to better select treatment for their patients whose breast cancer has this feature, and potentially allow the development of new drugs which can target the EMT process to increase cancer cell kill.
Interventions
To assess if the presence of markers associated with EMT in the primary and metastatic breast cancer (BC) specimens predicts for a worse outcome in terms of metastatic recurrence in patients who have received chemotherapy in the adjuvant setting, and in patient’s clinical response to cyclin D kinase inhibitors and eribulin in the metastatic setting.
Data stored in the Principal Investigator's secure patient database will be used to identify eligible participants. Primary tissue samples will be o
To assess if the presence of markers associated with EMT in the primary and metastatic breast cancer (BC) specimens predicts for a worse outcome in terms of metastatic recurrence in patients who have received chemotherapy in the adjuvant setting, and in patient’s clinical response to cyclin D kinase inhibitors and eribulin in the metastatic setting. Data stored in the Principal Investigator's secure patient database will be used to identify eligible participants. Primary tissue samples will be obtained from previous surgeries and metastatic tissue from standard of care (SOC) biopsies. Both will be available in local laboratories. A subset of eligible patients (prospective sub-type) who are currently receiving or are about to receive eribulin will be asked to consent to metastatic biopsy, or consent to use of SOC metastatic biopsy from prior to commencement of eribulin and at time of progression or cessation of treatment due to intolerability. There are no other requirements for patient to attend or participate actively in the study. Medical records, including pathology and radiology reports, and data from the PI's secure database will be reviewed both prospectively both retrospectively to identify new BC events, as well as detail on duration of systemic treatment delivery, to categorise the basis on which disease progression was determined. This will be defined as (i) unequivocal clinical progression alone, (ii) unequivocal radiological evidence of disease progression and/or new disease, and (iii) combined clinical and radiological evidence leading to determination of disease progression. Data is collected prospectively as to the significant site of disease progression leading to a change in systemic treatment, but greater detail will be obtained as to the site(s) of disease progression from reviewing clinical notes and radiological reports. Data are already collected for the study apart from the prospective subset. These patients will not be asked to attend any study-specific visits after metastatic biopsy. The estimated time for these patients to be on standard of care treatment with eribulin is 2 to 5 years.
Sponsors
Breast Cancer Research Centre - WA
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
a) Consent to use of tumour tissue b) Histologically confirmed BC with archived primary BC tissue available c) Diagnosis of metastatic BC where histological confirmation has been confirmed in patient with de novo metastatic BC or histological/ cytological / unequivocal radiologic diagnosis of metastatic disease in a patient with prior diagnosis breast cancer d) Patients with hormone receptor positive, HER2 negative BC who have (i) received a cyclin D kinase inhibitor in the adjuvant setting and who has experienced a BC recurrent event or (ii) received a cyclin D kinase inhibitor in the metastatic setting e) Any metastatic BC patient who has received at least one dose of eribulin in the course of their metastatic BC
Exclusion criteria
a) Non-breast metastatic malignancy after BC diagnosis b) Lost to follow-up (incomplete data in medical records and/or PI's secure database to provide adequate information) c) Inadequate tumour tissue for biomarker analysis
Outcome results
None listed