AKTivate
Research type
Research Study
Full title
Randomised Phase II open-label window of opportunity trial AKTivate - Identifying target engagement and biomarkers of response, including an imaging biomarker, in participants receiving Capivasertib plus Exemestane and Capivasertib alone in post-menopausal participants with oestrogen receptor positive (ER+) early-stage breast cancer.
IRAS ID
1009061
Contact name
Jean Abraham
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust & the University of Cambridge
ISRCTN Number
ISRCTN99425493
Research summary
Breast cancer is the most common cancer in UK women. Medical imaging like mammography (taking X-ray pictures) and ultrasound (using sound waves) are used to track changes in size of tumour over time. Unfortunately, it can take many weeks before changes large enough to tell if treatments are working are seen.
Tumour cells act differently to regular cells. Some of these differences can be used to get an earlier look at whether a treatment is working. Knowing a treatment isn’t working early on allows for quicker adjustments, increasing the chance of a good outcome and reducing the time patients suffer with side effects from ineffective treatments.
One thing that sets tumour cells apart is how they use sugar. Tumour cells take in more sugar from the blood and use it in a unique way. This leads to many types of tumours having lots of a natural substance called lactate.
In this proposed trial, AKTivate, we will use a new type of imaging called Hyperpolarised C13 Magnetic Resonance Imaging (MRI). This allows us to see lactate build-up in breast cancers. If a drug treatment is working well, the amount of lactate should fall. This usually happens at an earlier stage than changes in size.
60 women with early-stage oestrogen-positive (ER+) breast cancer will participate. These women will have hyperpolarised C13 MRI scans and cancer biopsies before and after 2 weeks of treatment in what we call a window of opportunity trial. All women will receive the drug capivasertib. Capivasertib has worked well in trials for advanced and metastatic breast cancer. AKTivate will gather information to help assess if it might work well against early-stage breast cancer. Half will also get a drug called exemestane. This is commonly used in early and advanced ER+ breast cancer.
AKTivate will assess if hyperpolarized C13 MRI can reliably assess whether capivasertib and exemestane are working within just 2 weeks. Funding is through a collaboration with AZ.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
24/NE/0180
Date of REC Opinion
5 Dec 2024
REC opinion
Further Information Favourable Opinion