Bosutinib combination with Exemestane in PM women/advanced breast CA
Research type
Research Study
Full title
A phase 2, randomised, open-labeled study of Bosutinib administered in combination with Exemestane versus Exemestane alone as second line therapy in postmenopausal women with locally advanced or metastatic ER+/PgR+/ErbB2-breast cancer
IRAS ID
19787
Contact name
Peter Barrett-Lee
Contact email
Sponsor organisation
Wyeth Pharmaceuticals
Eudract number
2008-002457-20
ISRCTN Number
NA
Clinicaltrials.gov Identifier
Research summary
This research study involves women who are postmenopausal and have been been diagnosed with locally advanced or metastatic breast cancer(MBC) which means that the cancer has travelled from the breast to another part of the body . Cancer cells can travel through either the lymphatic system (a system of organs, ducts and nodes which distributes cells around the body) or the blood vessels. As there is no cure for MBC, current therapy is palliative (relieving symptoms) or at best , delays disease progression.
The main purpose of this study is to learn more about the experimental drug Bosutinib in combination with a marketed drug Exemestane, compared with the Exemestane alone. The study will assess the subject’s quality of life and how well the subject’s is feeling when taking the study medication.The study is split into two parts, this application is for part 2 only .
All study related examinations will be carried out in a hospital setting. Patients will sign an informed consent form before any tests or examinations are performed. Each subject’s suitability will be assessed during the screening process prior to enrolment.
Eligible subjects will be randomised to receive either SKI 606 Bosutinib in combination with Exemestane or Exemestane alone. The treatment period will be for 6 months and the subject will be followed up every 8 weeks for tumour assessments, survival follow up every 12 weeks up to 24 months, after the first dose of the test article.
REC name
Wales REC 1
REC reference
09/WSE04/46
Date of REC Opinion
8 Oct 2009
REC opinion
Further Information Favourable Opinion