3160A6-2207 post menopausal women with advanced /metastatic breast CA
Research type
Research Study
Full title
A phase 2, randomized, open label study of Bosutinib administered in combination with Letrozole versus Letrozole alone as first line therapy in post menopausal women with locally advanced or metastatic ER+/PgR+/erbB2-breast cancer.
IRAS ID
18405
Sponsor organisation
Wyeth Pharmaceutials
Eudract number
2008-006252-21
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 Letrozole, compared with the Letrozole alone. The study will assess how well the subject??s quality of life is 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 Bostuinib in combination with Letrozole or Letrozole 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 37 months, after the first dose of the test article.
REC name
Wales REC 1
REC reference
09/WSE04/45
Date of REC Opinion
8 Oct 2009
REC opinion
Further Information Favourable Opinion