FINER

Closed

BCT 2101/CCTG MA.40: FINER

BCT Study Chair:

Andrew Redfern

The FINER clinical trial aims to find out if cancer will remain under control for longer in patients with advanced ER-positive and HER2-negative breast cancer.

australia & new zealand

70

AUSTRALIA & NEW ZEALAND

Total number of trial participants

in Australia and New Zealand

total finer accrual

250

TOTAL FINER ACCRUAL

Total number of

participants internationally

institutions

19

INSTITUTIONS

Total number of participating institutions

in Australia and New Zealand

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.

the finer clinical trial
associate professor andrew redfern is the bct study chair of the finer clinical trial

2022

CCTG MA40: Double-Blind Placebo Controlled Randomized Phase III Trial of Fulvestrant and Ipatasertib for Advanced HER-2 Negative and Estrogen Receptor Positive (ER+) Breast Cancer Post First Line CDK 4/6 and Aromatase Inhibitor Therapy (FINER).

Chia SK, Cescon DW, Redfern AD, Rodin D, Simmons C, Ayoub J-P, Chalchal HI, Rayson D, Rushton-Marovac M, Hay T, Callinaro L, Chen B, Parulekar W. San Antonio Breast Cancer Symposium. 2022; Abstract# OT3-26-01, Abstract

FIND OUT MORE INFORMATION