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FAKTION

A phase 1b/2 randomised placebo controlled trial of fulvestrant +/- AZD5363 in postmenopausal women with advanced breast cancer previously treated with a third generation aromatase inhibitor.

FACTION results video

Background

Breast cancer cells which have the estrogen receptor (ER positive or ER+) are more likely to grow when estrogen is present in the bloodstream. This can be treated by drugs that interfere with the action of estrogen or the estrogen receptor. Examples of this include Tamoxifen, and the Aromatase Inhibitors (Anastrozole Letrozole and Exemestane). Although these drugs are often effective for a while, the cancer can frequently become resistant and the drugs stop working. Patients then require treatment with chemotherapy. In this trial, we are investigating whether we can reverse resistance to hormone therapy by adding an additional oral drug called AZD5363. This is a targeted therapy that blocks the action of a cellular protein called Akt, which has been shown to cause resistance to hormone therapy. We will combine this drug with fulvestrant, another hormone therapy which is sometimes used alone in patients who have developed resistance to Aromatase Inhibitors, or Tamoxifen. Thus, patients entering the trial will have a known drug with proven efficacy and will also possibly receive the experimental drug which may enhance activity.

Two phase study

The study is divided into two phases. The first phase is now closed to recruitment; it involved a small number of patients to test if fulvestrant and AZD5363 could be combined in a safe manner (safety run in phase 1b). All patients received a standard dose of fulvestrant and the phase 1b was used to determine the dose of AZD5363 used in phase 2. The dose of AZD5363 determined to be safe for use in phase 2 was 400mg.  This is a randomised controlled phase 2 trial where half the patients will receive fulvestrant alone (plus a dummy drug - placebo) and half will receive a combination of the fulvestrant and AZD5363 at 400mg. This will involve a larger number of patients and will allow us to compare the anticancer activity of fulvestrant alone versus fulvestrant and AZD5363.

Investigating resistance to hormone therapy

This trial is investigating whether it is possible to reverse resistance to hormone therapy by adding an additional oral drug called AZD5363. This is a targeted therapy that blocks the action of a cellular protein called Akt, which has been shown to cause resistance to hormone therapy. This drug will be combined with fulvestrant, another hormone therapy which is sometimes used alone in patients who have developed resistance to Aromatase Inhibitors, or Tamoxifen.

Recruitment targets

9-12 for Phase 1b (recruited 9; Phase 1b is now closed)

138 for Phase 2 (currently recruiting)

The trial has specific eligibility criteria to select participants who might be treated safely and have a good chance of receiving benefit from the treatment.

Information

Key facts

Start date 1 Jan 2014
End date 1 Feb 2017
Grant value £674,000
Status
  • Analysis and reporting

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