FAKTION

Female researcher looking into microscope

A randomised placebo controlled trial in postmenopausal women with advanced breast cancer previously treated with a third generation aromatase inhibitor.

Background

In 2010, 49,564 UK women were diagnosed with invasive breast cancer and 11,556 died. Endocrine (hormone) therapy will cure 30% of women with undetected micro-metastatic disease but 70% will relapse and subsequently die from Estrogen Receptor Positive (ER+) endocrine resistant metastatic breast cancer.

FAKTION will investigate whether we can reverse resistance to hormone therapy by adding an additional oral drug called AZD5363.

AZD5363 is a targeted therapy that blocks the action of Akt, a cellular protein shown to cause resistance to hormone therapy. AZD5363 will be combined with fulvestrant - another hormone therapy sometimes used alone in patients who have developed resistance to Aromatase Inhibitors or tamoxifen.

Study design

FAKTION has four stages:

  • initial Phase 1b dose escalation study (stage 1)
  • subsequent Phase 2 double blind randomised controlled trial (RCT) (stages 2-4).

Phase 2 is divided into three stages as pre-clinical data support the concept that AZD5363 may be more active in tumours with PI3K/Akt/PTEN pathway activation.

Recruitment

The target recruitment for FAKTION is 150 patients.

Working alongside study sites with similar eligibility criteria

Phase 1b (now closed) reached its target of nine patients. Recruitment for Phase 2 has been slower than anticipated. Competing AZ-funded studies FURVA and MANTA recruit the same patient population restricting sites available to open FAKTION.

We are collaborating with the MANTA study to recruit their top accruing sites when their recruitment ends (August 2016). We believe by attracting these sites to a trial with almost identical eligibility criteria we will facilitate better patient accrual to FAKTION than pursuing sites with relatively little research activity that have not already expressed interest to open MANTA, FAKTION or FURVA.

Research impact

This research will contribute significantly to international knowledge base and could lead to significant change in clinical practice.

News reports including Chief Investigator and participating patient views on this study in ITV Wales news, Wales Online and the Experimental Cancer Medicine Centre (ECMC) Network.

Funders: AstraZeneca and Cancer Research UK