Highlights & news

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 set to be 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.

Trial timeline and results

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). This type of breast cancer involves the hormone oestrogen, which can cause cancer to grow by attaching to receptors on tumour cells. Hormone therapies such as Fulvestrant can slow the cancer’s growth, but over time many patients develop a resistance to treatment, inevitably leading to the cancer’s progression. Research shows that a particular protein, known as AKT, plays a significant role in driving this resistance. When patients have specific genetic mutations in their cancer, the AKT protein becomes activated, allowing cancer cells to survive and grow.

The Welsh-led FAKTION trial, involving over 140 patients across 19 hospitals in the UK, was the first of its kind to target this genetic pathway in breast cancer with extraordinary results. The study investigated whether AstraZeneca’s drug, Capivasertib, which inhibits AKT activity, could be safely combined with standard hormone therapy to improve the outlook for patients with advanced breast cancer that had worsened despite treatment. Researchers were keen to understand whether this new treatment combination could extend the time during which the cancer could be controlled and whether specific genetic mutations within the patient’s cancer influenced their outcomes.

The astonishing results revealed that the combination of Capivasertib with hormone therapy controlled this type of advanced breast cancer for twice as long as standard treatment alone.

Specifically, patients who had common genetic abnormalities in their cancer—found in 55% of participants in the FAKTION triallived for an average of 39 months when treated with Capivasertib and Fulvestrant together, compared to 20 months for those receiving Fulvestrant and a placebo drug.

These findings highlighted the potential of Capivasertib to nearly double survival times for patients facing certain types of incurable breast cancer.

The incredible results of FAKTION triggered a larger trial known as CAPItello 291.

This global study, initiated by AstraZeneca, further evaluated the potential of using Capivasertib and Fulvestrant together, confirming the ground-breaking results of FAKTION and reinforcing the success of the new combined treatment. In 2023, the FDA approved Capivasertib, under its newly licensed name, Truqap. Together with hormone therapy, it is set to be the standard treatment for patients with hormone receptor (HR) positive and human epidermal growth factor receptor 2 (HER-2) negative breast cancer where they also have common genetic mutations in their cancer.

Now with NICE approval, this life-changing new treatment will be rolled out to patients in UK clinics in 2025.

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. Professor Rob Jones highlighted that of 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 with metastatic cancer [a cancer that has spread], 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 curebut 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.

One participant that experienced the immeasurable impacts of the FAKTION trial was Farhana Badat. Farhana, a former postmistress from Newport, was diagnosed with breast cancer in 2013 following her first mammogram at aged 50. After undergoing surgery and treatment, Farhana was hopeful that the cancer had gone into remission. However, in 2016, she received the devastating news that the cancer had spread to her bones. Farhana was told that her cancer was now incurable, having become resistant to hormone therapy. Shortly after, Farhana was invited to take part in the FAKTION clinical trial at Velindre Cancer Centre.

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 the 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.”

Farhana still visits Velindre for regular check-ups, and she says she was proud to have taken part in research that could help extend the lives of others with incurable breast cancer:

“I feel like if you even help one person and if they get as much fun and joy out of life then it’s worth it in the end. I’m very proud of it helping other people and if I’d gone down the normal route, I don’t know if I’d even be here today.”

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.

 Reflecting on the time with her family, Farhana shared:

“I’ve enjoyed every moment with them, and you begin to realise how much you can enjoy—you have to live every moment as best you can.”

Together, we can give patients like Farhana, the gift of hope and precious time with their loved ones.

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