SOLE Study of Letrozole Extension

• Research type

  Research Study

• Full title

  A phase III trial evaluating the role of continuous letrozole versus intermittent letrozole following 4 to 6 years of prior adjuvant endocrine therapy for postmenopausal women with hormone-receptor positive, node positive early stage breast cancer.

• IRAS ID

  29695

• Contact name

  Alastair Thompson

• Sponsor organisation

  International Breast Cancer Study Group (IBCSG)

• Eudract number

  2007-001370-88

• ISRCTN Number

  Application pending

• Research summary

  Questions remain about the optimal duration and best schedule of aromatase inhibitor drug therapy in the extended adjuvant setting (after 5 years of adjuvant endocrine therapy). This trial tests the hypothesis that introducing 3-month treatment-free intervals during the course of five years of extended adjuvant letrozole will improve disease-free survival. This hypothesis is based on the principle that withdrawal of oestrogen suppression for 3 months each year will permit some estrogenic stimulation of occult breast cancer cells which will then allow this residual disease to be susceptible to re-introduction of the anti-oestrogen therapy.

• REC name

  West of Scotland REC 1

• REC reference

  09/S0703/117

• Date of REC Opinion

  26 Jan 2010

• REC opinion

  Further Information Favourable Opinion