Functional Assessment of Bone Metastases 2 (FABB2)

• Research type

  Research Study

• Full title

  Measurement of αvβ3 integrin expression in breast cancer skeletal metastases to monitor treatment response

• IRAS ID

  246316

• Contact name

  Reza Razavi

• Contact email

  reza.razavi@kcl.ac.uk@kcl.ac.uk

• Sponsor organisation

  King's College London

• Duration of Study in the UK

  1 years, 11 months, 30 days

• Research summary

  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.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  19/LO/0206

• Date of REC Opinion

  17 Apr 2019

• REC opinion

  Further Information Favourable Opinion