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Malignant neoplasm of breastMalignant neoplasms of ill-defined, secondary and unspecified sites
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Background:
There is an unmet need to measure early treatment response in cancer that has spread to the skeleton (bone metastases) to improve treatment outcomes and reduce treatment-related side effects.
αvβ3 integrin is a protein that is implicated in the development and progression of bone metastases in breast cancer and it appears on the bone cells that cause much of the damage to the skeleton (osteoclasts). We have previously shown that measuring αvβ3 integrin expression (with a 99mTc-maraciclatide SPECT scan) predicts treatment response in prostate cancer bone metastases and is likely to be related to changes in osteoclast activity.
Aims:
Determine the level and variability of αvβ3 expression in breast cancer bone metastases (using 99mTc-maraciclatide SPECT imaging).
Measure changes in αvβ3 expression after 12 weeks systemic treatment to determine if this predicts early treatment response.
Correlate αvβ3 expression changes with serum and imaging markers of osteoclast and
tumour activity to determine if αvβ3 expression is mainly related to tumour or osteoclast activity.
Techniques and Methodology:
Measurement of αvβ3 expression: 99mTc-maraciclatide SPECT: baseline and 12 weeks after commencing endocrine therapy (+ bisphosphonate +/- denosumab) in bone-predominant metastatic breast cancer.
Quantify αvβ3 expression in bone metastases at both timepoints by measuring 99mTc-maraciclatide tumour to muscle ratios.
Outcomes:
Accuracy of changes in αvβ3 expression in prediction of treatment response at 12 weeks.
Correlate treatment-related change in αvβ3 expression with changes in serum osteoclast and imaging tumour markers to elucidate likely mechanisms of αvβ3 expression (tumour vs osteoclast) in bone metastases.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Observational type: Validation of investigation /therapeutic procedures;
You can take part if:
You may not be able to take part if:
Concomitant uncontrolled medical conditions, contraindications to radionuclide imaging, patients likely to require palliative radiotherapy within the first 12 weeks of treatment, estimated prognosis < 3 months.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by King's College London and funded by Breast Cancer Now .
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Read full details
for Trial ID: CPMS 40952
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