Randomised Open-label Phase II study of induction standard of care Fulvestrant and CDK4/6 inhibition with the Addition of Ipatasertib in Metastatic ER+/HER2- breast cancer patients without ctDNA suppression (FAIM)

Research summary

The FAIM trial is a phase II, multicentre, randomised trial in patients with hormone-receptor (HR) positive and HER2 negative advanced breast cancer, suitable for standard of care fulvestrant+CDK4/6 inhibitor with a known trackable mutation and no contraindication to ipatasertib. The study aims to determine whether adding a new drug called ipatasertib helps breast cancer to be controlled for longer if it is added to a standard combination of the hormone treatment fulvestrant, and the targeted agent palbociclib. Palbociclib is a drug used in routine care for hormone-receptor (HR) positive and HER2 negative advanced breast cancer. Palbociclib inhibits two important controllers of cell growth; cyclin dependent kinase 4 and cyclin dependent kinase 6 (CDK4/6). Inhibiting CDK4/6 stops cells, such as cancer cells, from dividing and multiplying further. Its use is currently approved for the treatment of metastatic HR positive HER2 negative breast cancer. Fulvestrant is an oestrogen receptor down regulator and blocks the effects of oestrogen on oestrogen receptor positive (ER+ve) breast cancer cells. Fulvestrant is an approved hormone therapy which patients with breast cancers are receiving in the clinic. It is possible that the combination of ipatasertib with palbociclib and fulvestrant will shrink tumour(s) more effectively and prevent further growth. It is possible that the combination of ipatasertib with palbociclib and fulvestrant will be a more effective cancer treatment than palbociclilb and fulvestrant alone, but this is unknown and this study is being performed to test this.

Principal Investigator

Jaseela Chiramel

Contact us

Email: latephaseoncology@ouh.nhs.uk

IRAS number

284870