Clinical Trial Shows Promise in Slowing Advanced Breast Cancer Progression

The CCTG MA.40 (FINER) clinical trial, is a double-blind placebo controlled randomized phase III trial of fulvestrant and ipatasertib as treatment for advanced HER-2 negative and estrogen receptor positive (ER+) breast cancer following progression on first line CDK 4/6 inhibitor and aromatase inhibitor.

In an important clinical trial research finding for advanced breast cancer treatment, the Canadian Cancer Trials Group (CCTG) has announced the results from the MA.40 clinical trial. These study results highlight the importance of targeting the AKT pathway to slow tumour progression in patients with advanced estrogen receptor-positive (ER+)/HER2-negative breast cancer.

The CCTG MA.40 FINER trial results were presented at ASCO 2025 by study chair, Dr. Stephan Chia. The study evaluated whether adding the drug Ipatasertib to standard therapy (fulvestrant) could slow the progression of advanced ER-positive, HER2-negative (ER+/HER2-) breast cancer—the most common subtype. 

“More effective treatments are required after standard first line targeted and endocrine therapy in ER+/HER2- negative advanced breast cancer. This trial has demonstrated an ability to identify potential therapeutic targets with a blood test after first line therapy and shows targeting the AKT pathway with ipatasertib and fulvestrant can improve progression free survival – particularly in the AKT pathway altered cohort” says the MA.40 principal investigator Dr Stephen Chia. Medical Oncology, British Columbia Cancer Agency.

The trial demonstrated that drugs that disrupt cancer cell signalling pathways can delay the spread and/or growth of the tumour in the advanced breast cancer setting. Cancer spread was delayed with the addition of the drug Ipatasertib to fulvestrant therapy in patients with ER+/Her2- advanced breast cancer, especially those with specific mutations in their breast cancer.

“Ongoing research around tumour biological molecules will help us to understand why some patient’s tumours are controlled with specific drug combinations and conversely, why some are not,” says the MA.40 senior investigator Dr Wendy Parulekar.

The administration of drugs that target tumour vulnerabilities is an important treatment strategy and is increasingly incorporated in clinical care. However, clinical trials are needed to identify drugs or combinations of drugs that target different tumour pathways, safely delay tumour spread, maintain quality of life and ultimately, increase survival.

The MA.40 FINER trial was a successful international collaboration between the Canadian Cancer Trials Group (CCTG) and Breast Cancer Trials (BCT) in Australia and New Zealand. The study was funded through the generous support of the Canadian Cancer Society with backing from Roche.