CaptAin

• Research type

  Research Study

• Full title

  Effect of Capivasertib on ctDNA in ER positive breast cancer

• IRAS ID

  1005281

• Contact name

  Lee Webber

• Contact email

  lee.webber@imperial.ac.uk

• Eudract number

  2022-000802-82

• Clinicaltrials.gov Identifier

  NCT06613516

• Research summary

  Approximately 75% of breast cancers are oestrogen receptor positive, meaning that they contain targets that the hormone oestrogen can activate, causing the cancer cells to divide and spread. A standard treatment is a hormone therapy called an aromatase inhibitor (AI) that stops production of oestrogen and helps to control cancer growth. There is a risk of the cancer coming back, and research has shown that the presence of detectable cancer DNA in the blood (circulating tumour DNA or ctDNA) can be an early sign that the cancer is likely to relapse. The aim of this study is to investigate whether treating women with a new drug called capivasertib can help control these ctDNA levels, and whether it is possible to monitor ctDNA effectively over time in a way that would justify future, larger clinical trials. Capivasertib is a targeted therapy, which works by blocking the function of a protein called AKT, known to perform various roles contributing to cancer growth and spread.

  This study will be based at Imperial College Healthcare NHS Trust, and consent and screen potentially eligible women to determine whether they have detectable ctDNA, which will require access to cancer tissue and donation of a blood sample. Potentially eligible women will have had standard treatment to cure breast cancer, and received more than 6 months of an AI that is planned to continue for at least 2 more years. Eligible women with detectable ctDNA will be enrolled into the study and receive capivasertib until either relapse or unacceptable side effects, or for 2 years, whichever occurs first. Enrolled women will be required to donate regular blood samples throughout treatment for monitoring of ctDNA, in addition to imaging scans to check for signs of breast cancer.

  20 women with detectable ctDNA will be enrolled to receive capivasertib, requiring about 120 women to be consented and screened.

  This study is sponsored by Imperial College London and funded by AstraZeneca.

  Results Summary
  No results due to early termination of study

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  24/NW/0288

• Date of REC Opinion

  28 Oct 2024

• REC opinion

  Further Information Favourable Opinion