This international early phase clinical trial, known as the FERGI trial, is testing a new oral chemotherapy drug called a PI3 kinase (PI3K) inhibitor. These drugs inhibit a protein called “PI3-kinase” that may be involved in the growth and spread of some cancers. This research examines the use of a PI3K inhibitor in combination with the hormonal treatment fulvestrant (given as an intramuscular injection).
The trial is open to post-menopausal women who have advanced or metastatic breast cancer that is positive for the oestrogen receptor (ER positive) and negative for the human epidermal growth factor receptor 2 (HER2 negative) and whose disease has worsened while receiving treatment with an aromatase inhibitor (e.g. letrozole or anastrozole). In addition, enrollment in this trial is limited to women whose tumour contains a mutation in the PI3K gene. This gene can be abnormal in up to 35% of patients with ER positive breast cancer.
Currently metastatic breast cancer remains an incurable illness despite a number of more effective treatments. This study will evaluate whether the drug under study is safe and effective and whether it extends survival from metastatic breast cancer.
The sponsor of this research is Genentech Inc (a member of the Roche Group). Christchurch and Waikato Hospitals are the two New Zealand centres enrolling patients in the FERGI trial.
250 patients will take part from 110 study centres in the US, European Union, Canada and from other countries around the world. There are two parts to this trial; Part 1 is completed and Part 2 will close to further enrolment in August 2013. If you are interested in this clinical trial ask your medical oncologist if it is right for you.
For more information about how clinical trials work and other trials that are underway in New Zealand, click here.
