Study reveals combining standard treatment with investigational therapy may extend life by up to six months
A significant advance in research for new breast cancer treatments was reported today at a world leading cancer research conference in Chicago.
A clinical trial jointly led by cancer researchers at The Velindre Cancer Centre, Cardiff University together with The Christie NHS Foundation Trust in Manchester aims to improve treatment options for millions of patients with devastating breast cancer around the world.
By adding an investigational compound, capivasertib, to an existing endocrine therapy used to treat ER+ (oestrogen receptor positive) breast cancers, (fulvestrant), the FAKTION trial has shown significant improvements both in the length of time the cancer is kept under control and that patients survived.
The study has shown that the investigational combination controlled cancer growth in women with advanced breast cancer for an average of six months longer (10.3 months) than those treated with the standard hormone treatment and a placebo (4.8 months). The data also indicate that patients treated with the combination may survive for up to six months longer than those who received the standard therapy.
his academic trial, sponsored by Velindre University NHS Trust, was jointly led by Dr Sacha Howell (The Christie NHS Foundation Trust and The University of Manchester) and Dr Rob Jones (Cardiff University and Velindre Cancer Centre) and It involved 140 patients, across 19 UK hospitals, who had been diagnosed with breast cancer amenable to hormone treatment (oestrogen receptor positive cancer). This is the most common type of breast cancer affecting approximately three quarters of all breast cancer patients.
Dr Sacha Howell, Co-chief investigator of the trial from The Christie NHS Foundation Trust and The University of Manchester said: “We are thrilled with the FAKTION trial results and to have been top recruiters to the study here in Manchester. Every year around 6,100 people are diagnosed with breast cancer in the North West alone, that's 17 every day*. The trial results and our own experience indicate that further evaluation of this potential treatment combination for patients with ER+ breast cancer is warranted. This bodes well for a larger phase 3 study which we hope would confirm the six month increase in overall survival seen in FAKTION. As breast cancer is the most common cause of cancer death worldwide the results of a follow-on phase 3 study could have a major impact globally.”
Breast cancer is the most common type of cancer in the UK. There are around 55,000 new breast cancer cases nationally every year, that's around 150 every day with 11,000 people dying from the diseases each year in the UK alone. There are a number of different types of breast cancers but by far the most common is oestrogen receptor positive breast cancer which occurs in 70-75% of cases. This type of breast cancer can be treated by drugs that interfere with the action of oestrogen on the oestrogen receptor. Although these drugs are often effective for a while, the cancer eventually becomes resistant and the drugs stop working.
In this trial, researchers investigated whether they could reverse or delay resistance to hormone therapy in post-menopausal women whose breast cancer had spread by adding capivasertib to existing therapy. Capivasertib is an investigational, targeted therapy which neutralises a protein in cancer cells called AKT, that has been shown to cause resistance to hormone therapy. Capivasertib was combined with fulvestrant, a hormone therapy which is currently given routinely to treat breast cancer. Capivasertib was discovered by AstraZeneca following a collaboration with Astex Therapeutics (and its collaboration with the Institute of Cancer Research and Cancer Research Technology Limited).
All patients entering the trial received the licensed medicine Fulvestrant, while those who were not on the placebo were also given the experimental AKT inhibitor (capivasertib) in the hope that this combination would be more effective. Today’s results suggest that their hopes were well founded.
Approximately 70% of patients in the trial had cancer that could be accurately and reliably measured on scans (patients with measurable disease). Careful examination of these scans demonstrated that 41% of patients who received fulvestrant together with capivasertib experienced a significant shrinkage in their cancer compared to only 12% of patients who were allocated to fulvestrant and a placebo.