FINER

The FINER Clinical Trial

The most common subtype of breast cancer is hormone receptor-positive, HER2 negative (ER+/HER2-). Endocrine (hormone) treatments with drugs called CDK 4/6 inhibitors are effective to treat ER-positive, HER2-negative breast cancers. However, in advanced cancer, the cancer eventually grows or spreads despite initial endocrine treatment in most cases. That means this treatment is not effective anymore and other treatments are needed for these resistant cancers.

All living cells (including tumour cells) have functions that make them develop, grow, survive and die. The PI3K-AKT-mTOR pathway within cells is important for cell growth and survival, and it may cause some ER-positive cancers to become resistant to endocrine treatments. The drug ipatasertib can prevent the growth of cancer cells through this pathway.

The FINER clinical trial aims to find out if cancer will remain under control for longer in patients given ipatasertib and fulvestrant, compared with the usual treatment of giving fulvestrant on its own.

Ipatasertib and placebo are tablets; fulvestrant is an injection into the muscle. They are taken as follows over a cycle (1 cycle =28 days):

Arm A: Ipatasertib tablets once per day with water for 21 out of 28 days, plus a fulvestrant injection into the muscle of each buttock on day 1 and day 15 of Cycle 1, day 1 of Cycle 2, and then every 28 days.

Arm B: Placebo tablets once per day with water for 21 out of 28 days, plus a fulvestrant injection into the muscle of each buttock on day 1 and day 15 of Cycle 1, day 1 of Cycle 2, and then every 28 days.

Participants will have clinic visits at Week 1, Week 3, Week 5 and then every 4 weeks until treatment stops. They will be followed every 12 weeks after end of treatment.

FINER will be managed in Australia and New Zealand in partnership with the Canadian Cancer Trials Group (CCTG). 250 participants will be randomised over 18 months including 60-80 patients in Australia and New Zealand.