TNBC:Novel functional imaging to determine early chemotherapy response

• Research type

  Research Study

• Full title

  A randomised Phase II trial of [18F]-fluorothymidine and [18F]-Fluorodeoxyglucose in the assessment of systemic therapy response in triple negative breast cancer and its utility compared to conventional MRI imaging response, early ADC change and biopsy derived biomarkers.

• IRAS ID

  67762

• Contact name

  Andrew Tutt

• Sponsor organisation

  King's College London

• Eudract number

  2011-004220-34

• ISRCTN Number

  xx

• Research summary

  Breast cancer is the most common female cancer, affecting 1 in 8 women through their lifetime. Approximately 15% are negative for the hormone receptors and HER2 receptor and are termed triple negative (TNBC). Treatment often requires chemotherapy to shrink the tumour prior to surgery and improve the chances of cure. Some patients respond poorly to treatment and these patients have a high likelihood of metastatic relapse and death at a later date which accounts for the overall poor prognosis seen with TNBC. The current 'gold standard' for evaluating response to neoadjuvant chemotherapy in early breast cancer is magnetic resonance imaging (MRI). This is limited by the time lag from start of therapy to measurable change in tumour size which is equivalent to about 3 cycles of chemotherapy treatment. During this time the patient may have experienced side effects potentially without benefit. In some other types of cancer, such as lymphoma, functional imaging scans can tell after only a few weeks whether chemotherapy is working well enough. These scans work by detecting changes in tumour metabolism due to chemotherapy which may occur before a change in size.This study will test whether Positron Emission Tomography scans (PET) can also be used in women with TNBC to tell after only two weeks into treatment if chemotherapy working. We will compare the changes seen on a PET scan after the first cycle of chemotherapy with changes seen on a biopsy, later MRI scan after at least 3 cycles of chemotherapy and residual disease at definitive surgery. If proven to be useful these scans would enable doctors to identify those women where chemotherapy was not working at an early stage. This would allow a rapid change to other treatments and prevent unnecessary side effects in patients for whom treatment is working poorly.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  11/LO/1492

• Date of REC Opinion

  5 Dec 2011

• REC opinion

  Further Information Favourable Opinion