ARTiST

• Research type

  Research Study

• Full title

  ARTiST - Aromasin Randomised Trial +/- Sutent as neoadjuvant Therapy for post-menopausal women with breast cancer.

• IRAS ID

  4333

• Sponsor organisation

  Cambridge University Hospitals NHS Foundation Trust

• Eudract number

  2008-006161-84

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  The objective of the ARTiST trial is to determine whether the addition of a new treatment: sunitinib to a standard hormonal treatment pre-surgery is more effective than the hormonal treatment alone in post-menopausal breast cancer patients.Endocrine (Hormonal) therapy is a well established treatment modality used in breast cancer but around 30-50% of patients do not benefit from treatment. This study will assess the role of a new class of drugs called angiogenesis inhibitors, which blocks formation of new blood vessels, as a treatment modality in combination with established endocrine therapy.There is emerging evidence that angiogenesis inhibitors will be an important therapeutic option in breast cancers with the latest research from the advanced disease studies showing encouraging activity. Angiogenesis inhibitors should ideally be used early on in treatment as the tumours are small at the early stage and any blockage of blood vessel formation this early on in treatment will have important therapeutic effects. Sunitinib is one such drug and has been shown to be effective in advanced tumours. We aim to assess its safety and efficacy in breast cancer in the neoadjuvant setting, in combination with a steroidal aromatase inhibitor, exemestane.Neoadjuvant therapy in the context of breast cancer is a course of treatment undertaken before surgery, with the intention of downstaging (shrinking) the tumour, before the operation to excise it. It allows us to assess response to new treatments, carry out sequential removal of tumour material to assess for markers of response and assess the role of new imaging modalities in assessing early response to treatment.This study will enable us to identify markers of response to or resistance to angiogenesis agents and endocrine therapy so helping the future development in personalised therapy.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  08/H0304/125

• Date of REC Opinion

  20 Apr 2009

• REC opinion

  Further Information Favourable Opinion