Real Stories, Real Impact
Velindre’s FAKTION trial paves the way for a transformative new breast cancer treatment!
Velindre’s FAKTION trial paves the way for a transformative new breast cancer treatment!
FAKTION will have a monumental global impact—potentially doubling survival times for those with advanced breast cancer and offering hope to millions of people worldwide.
The world-renowned FAKTION trial started as an idea, born out of a conversation over 10 years ago between three people in a room in Cardiff.
They were discussing ways to improve patient outcomes in the world’s most common type of cancer—oestrogen receptor positive (ER+) breast cancer. Fast forward to 2025 and the research from this ground-breaking trial is being rolled out to patients at Velindre and other UK clinics as a transformative new breast cancer treatment.
The trial, co-led by Professor Rob Jones, was developed in collaboration with Cardiff University’s Centre for Trials Research with Velindre University NHS Trust acting as Academic Sponsor. Part-funded by Velindre Cancer Charity and Cancer Research Wales, with support from AstraZeneca and Cancer Research UK, the trial placed Velindre at the forefront of revolutionary cancer treatments and highlighted our commitment to delivering world-class research and clinical trials in Wales and beyond
ER+ breast cancer accounts for 70-80% of the 56,000 breast cancer cases diagnosed each year in the UK
(Cancer Research UK, 2017-2019).
The Welsh-led FAKTION trial, involved over 140 patients across 19 hospitals in the UK
FAKTION findings potentially double the survival time of patients
Trial timeline and results
2012
Where it all began
The trial concept was initiated by Dr. Rob Jones, Peter Barrett-Lee, and Julia Gee, paving the way for innovative research.
2013/2014
From Vision to Reality: The First Steps
Phase 1b of the trial launched to assess the tolerability of combining fulvestrant with Capivasertib in patients. The study was successfully completed, marking a key milestone in advancing treatment options.
2015
From Foundation to Expansion: Phase 2 Ignites
Phase 2 of the trial launched across 25 UK sites, with patients split into two groups—one receiving fulvestrant and Capivasertib, and the other receiving fulvestrant with a placebo.
2018
Building Momentum: Trial Hits Recruitment Target
Successfully recruited 140 patients to participate in the trial, marking a key milestone in the study’s progress.
2019
Breakthrough Confirmed: Data Reveals Incredible Results
The initial FAKTION trial data revealed a significant breakthrough—patients experienced triple the response rates and clinicians found that the cancer was controlled for twice the duration, demonstrating a significant benefit to administering the treatment.
2022
Momentum in Motion: Phase 3 Confirms Findings
Phase 3 the Capitello 291 Phase 3 trial releases initial data, reinforcing the key findings from FAKTION and further validating its results.
2023
Breaking Barriers: FDA Approves Revolutionary Drug
The FDA grants approval for the first-in-class, first-licensed indication of the Capi/Fulvestrant combination, backed by pivotal data from the FAKTION and Capitello 291 trials.
2024
EMA & MHRA Approval: Expanding Life-Changing Treatment Across Europe & the UK
The FDA grants approval for the first-in-class, first-licensed indication of the Capi/Fulvestrant combination, backed by pivotal data from the FAKTION and Capitello 291 trials.
2025
NICE Approval Secured: A Major Step Forward in Patient Access
Trial receives NICE approval, paving the way for broader patient access in the UK.
TODAY
Velindre Patients Benefit from Groundbreaking FAKTION Treatment
The impact on patients and families
The FAKTION trial will have a significant global impact, offering hope to patients with advanced breast cancer that are eligible for the new combined treatment.
The patients who took part in the trial, 55% saw improved outcomes. On a global scale, 55% translates to millions of patients worldwide whose lives could be extended.
Professor Rob Jones spoke of patients’ concerns when facing incurable cancer:
“When a patient is diagnosed, the most important question for the patient is ‘how long have I got? Am I going to see my grandchildren grow up?’
We’re not able to offer a cure—but we are buying people additional really important time they can spend with their families and friends.”
For this reason, the impacts of the FAKTION trial are hard to overstate.
Every extra moment that patients can spend with their loved ones is precious and this new treatment offers time they may not otherwise have had. It will give them the chance to make more memories, to enjoy life, to travel, and to watch their children and grandchildren grow up.
Initially given six months to live, Farhana’s participation in the FAKTION trial has meant she’s lived for an incredible seven more years since her diagnosis.
Speaking about impacts of the trial on her and her family, Farhana said:
“When I first came, I only had six months to live and now I’ve had seven years since then. I only had two grandchildren [then] and I now have six, so I’ve seen four born. We’ve had time together, we’ve done holidays together, places we wouldn’t have been if I’d been more ill.”
Speaking about impacts of the trial on her and her family, Farhana said:
“When I first came, I only had six months to live and now I’ve had seven years since then. I only had two grandchildren [then] and I now have six, so I’ve seen four born. We’ve had time together, we’ve done holidays together, places we wouldn’t have been if I’d been more ill.”
The difference you make
With your support, Velindre Cancer Charity invests millions of pounds every year into pioneering research and life-changing clinical trials, giving patients access to transformative, world-renowned treatments.
The FAKTION trial is just one example of the collaborative research taking place here in Wales—research that’s made possible because of generous donors and fundraisers like you. Your initial contributions help us to launch new clinical trials that bring research from the lab to the patient’s bedside and your ongoing support is the driving force that gets new treatments over the line.
By supporting Velindre Cancer Charity
you are making a real and life-changing difference to patients in Wales and beyond
Together, we can give patients like Farhana, the gift of hope and precious time with their loved ones.
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