CAPTURE TRIAL DELIVERS LEARNINGS FOR METASTATIC BREAST CANCER TREATMENT
1/06/2026
The CAPTURE breast cancer clinical trial has concluded that current standard of care, chemotherapy with capecitabine, in metastatic breast cancer continues to be an effective treatment for many patients.
The randomised, phase II clinical trial, run by Breast Cancer Trials in Australia and New Zealand, aimed to discover if women and men with hormone-receptor positive metastatic breast cancer may have benefited from a novel combination of drugs designed to improve progression free survival and offer a new treatment option.
The drug alpelisib is a class of drug called a PI3K inhibitor which can inhibit the growth and survival of cancer cells with a PIK3CA mutation. CAPTURE aimed to determine whether individuals with breast cancers that have the PIK3CA mutation detectable by circulating tumour DNA (ctDNA) in their blood were more likely to benefit from treatment with alpelisib, in combination with fulvestrant, compared to standard treatment with capecitabine.
“About 70% of breast cancers are ER-positive,” explained Professor Sarah Jane Dawson, Study Chair of the CAPTURE trial. “Endocrine (hormone) treatments for these cancers have been effective, but in advanced disease, the cancer eventually becomes resistant to initial endocrine treatment and the treatment is no longer effective, so we need other ways of treating these resistant cancers.”
Previous research has shown PIK3CA gene mutations, present in approximately 40% of patients with hormone-receptor positive breast cancer, may play a role in breast cancer becoming resistant to hormone treatments.
The PIK3CA gene mutations provide a ‘marker,’ showing which patients could benefit from different, more personalised treatment. The CAPTURE clinical trial used a liquid biopsy technique, which is a simple blood test to identify patients with the PIK3CA mutation from ctDNA analysis, and a much easier method than a traditional tissue biopsy.
“While it was hoped that this treatment would result in greater reduction of the growth of breast cancer for these patients, the trial showed that the outcomes were not superior to the current standard of care, which we know is an effective, well-tolerated option. This suggests that we need to identify better targeted therapies,” said Professor Dawson.
“We learn something from every trial. The next step is to use translational research from the tissue samples collected during CAPTURE to identify which of these patients may be best suited to the new therapy.
“The aim is to get the best treatment to the right person at the right time. Having blood based tests where we can identify which patients are most likely to respond to these therapies would be a huge step forward.”
The CAPTURE clinical trial involved 58 participants at 22 sites in Australia and New Zealand, and was open to both men and women. The results will be presented at the American Society of Clinical Oncology annual conference on Monday 1st June.
Dr Nick Zdenkowski, Medical Advisor to Breast Cancer Trials, said, “This trial supports continued use of oral chemotherapy that is cost-effective and well-tolerated when compared with alpelisib. The role of Breast Cancer Trials is to identify what we can do well, including academic independent trial design, considering the cost implications, and quality of life in the short term and long term – it’s not always about adding a more expensive treatment.”
Contact: BCT Media & PR Lead, Sara McGregor – 0424 591 241 or sara.mcgregor@bctrials.org.au
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