Dasatinib & Exemestane v Exemestane& placebo in Advanced Breast Cancer

• Research type

  Research Study

• Full title

  A Randomized, Double-Blind, Multi-Center Phase 2 Trial of Exemestane (Aromasin®) plus Dasatinib versus Exemestane plus Placebo in Advanced Estrogen Receptor-Positive Breast Cancer after Disease Progression on a Non-steroidal Aromatase Inhibitor (NSAI)

• IRAS ID

  7190

• Contact name

  Christopher Poole

• Sponsor organisation

  Bristol-Myers Squibb International Corporation

• Eudract number

  2008-003183-19

• ISRCTN Number

  N/A

• Research summary

  Breast cancer is the most common cancer in women in the UK. In spite of major advances in treatments, the disease recurs in approximately 30-40% of patients and advanced breast cancer remains incurable, with average survival only 2-3 years. Exemestane is widely used in patients with advanced breast cancer whom have failed anti-oestrogen therapy. The purpose of this study is to see if adding the study drug, dasatinib, to exemestane standard treatment improves progression free-survival. The study will also investigate if the study treatments reduce pain and other symptoms in patients whose cancer has spread to the bones (called bone metastases). Of the 172 patients to be enrolled, half will be randomly assigned to receive exemestane plus dasatinib and the other half exemestane and placebo (dummy drug). UK enrolment is anticipated to start in September 2009 and to end in May 2010. The study is funded by Bristol-Myers Squibb, and is being carried out at 3-5 centres in the UK. Patients who consent to participate in the study will undergo: 1. Physical examinations, heart function tests, blood tests, measurement of the breast cancer by scans (all patients), urine tests and completion of a pain questionnaire (patients with bone metastases only). 2. Treatment until the disease worsens or progresses, or if they experience unacceptable side effects. 3. Clinic visits after 2, 4 and 8 weeks of treatment and then every 8 weeks until the end of treatment. 4. Follow up: patients who completed the study prior to their disease worsening will continue to have scans to measure their breast cancer. Also where possible, patients will be contacted by the study doctor or nurse to check on the patient??s status and on any side effects which may have been continuing at the final visit.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  09/H0408/81

• Date of REC Opinion

  3 Aug 2009

• REC opinion

  Favourable Opinion