A study of LEE011 in ER+ HER2- breast cancer patients

• Research type

  Research Study

• Full title

  A phase Ib/II trial of LEE011 in combination with everolimus(RAD001) and exemestane in the treatment of postmenopausal women with oestrogen receptor positive HER 2 negative locally advanced or metastatic breast cancer.

• IRAS ID

  137121

• Contact name

  Charles Coombes

• Contact email

  c.coombes@imperial.ac.uk

• Sponsor organisation

  Novartis Pharmaceuticals Corporation

• Eudract number

  2012-005461-13

• Research summary

  This is a Phase Ib/ II study. Both parts of the trial will be conducted in postmenopausal women with ER+ (oestrogen receptor positive) Her2 negative advanced breast cancer that is resistant to previous letrozole or anastrozole treatment.
  The Phase Ib part of the study is designed to estimate the Maximum Tolerated Dose(MTD) for the combination of LEE011 with everolimus and exemestane. The phase Ib part of the study will also assess the safety and tolerability of the LEE011 + exemestane combination, including PK for both drugs. This assessment will be done in a small number of patients, as no clinically significant interaction is expected between LEE011 and exemestane.
  It is followed by a Phase II part to assess the clinical efficacy, safety and tolerability of two investigational treatments in patients with ER+ Her2- advanced breast cancer resistant to prior letrozole or anastrozole treatment. Patient in the dose expansion will receive either:
  • The triple combination of LEE011 + everolimus + exemestane (the L-R-E arm)
  • The combination of LEE011 + exemestane (the L-E arm)
  • The combination of everolimus + exemestane (the R-E arm)
  The findings from both investigational arms (L-R-E and L-E) will be compared to the
  approved combination of everolimus and exemestane (the R-E arm). In both onvestigational arms LEE011 will be administered orally, once daily for 21 consecutive days followed by a 7- day rest (28-day cycle); everolimus and exemestane will be administered orally, once daily on a 28 day schedule. Patients will be treated until progression of disease, development of unacceptable toxicity, or withdrawal of informed consent, whichever occurs first.

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  14/LO/1196

• Date of REC Opinion

  29 Oct 2014

• REC opinion

  Further Information Favourable Opinion