OUR
CLINICAL TRIALS

Nine clinical trials were open to recruitment during the reporting period, from 1 April 2024 to 31 March 2025.

BRCA-P

Preventing breast cancer in women with a BRCA1 gene mutation

The BRCA-P clinical trial is a world first international study that aims to prevent breast cancer in women with a BRCA1 gene mutation. It’s investigating if using the drug Denosumab is a safe and effective option for preventing breast cancer. In addition to exploring its use for breast cancer prevention, BRCA-P is investigating whether Denosumab decreases the risk of developing ovarian cancer or other types of cancers. The study is also assessing its effect on bone health, patient‑reported outcomes, side effects and biological markers. BRCA-P closed to recruitment in December 2024 and we look forward to the findings of this research.

Study Chair

Professor Geoffrey Lindeman

CAMBRIA-2

Preventing breast cancer from coming back for hormone receptor positive HER2 negative early breast cancer patients

CAMBRIA-2 aims to determine if a new type of endocrine treatment can reduce the chance of cancer coming back for people with hormone receptor positive, HER2 negative early breast cancer. The treatment being trialled is a type of endocrine treatment called a ‘selective oestrogen receptor degrader’ (SERD). The SERD works by breaking down the oestrogen receptors in cells, and also blocks the oestrogen receptors from being triggered by oestrogen. The purpose of CAMBRIA-2 is to find out if a SERD is better at reducing the chance of cancer from coming back, compared with the usual endocrine treatments such as letrozole, anastrozole, exemestane or tamoxifen.

Study Chair

Dr Nicholas Zdenkowski

CAPTURE

A targeted approach to the treatment of hormone receptor-positive metastatic breast cancer

The CAPTURE clinical trial aims to find out if women and men with hormone receptor‑positive metastatic breast cancer, with an identified mutation in a gene called PIK3CA, could benefit from a drug called alpelisib, in combination with fulvestrant. Hormone receptor-positive metastatic breast cancers eventually become resistant to standard therapies such as endocrine therapy and CDK4/6 inhibitors (such as palbociclib, ribociclib or abemaciclib) and it is thought that mutations in the PIK3CA gene may be associated with this resistance. Mutations in the PIK3CA gene of cancer cells can be identified through a specialised blood test for circulating tumour DNA. The study is investigating if the addition of alpelisib with fulvestrant, for patients with a detectable PIK3CA gene mutation, will improve progression-free survival and offer a new treatment option. CAPTURE closed to recruitment in December 2024 and we look forward to the findings of this research.

Study Chair

Professor Sarah-Jane Dawson

EXPERT

Personalising the use of radiation therapy in early breast cancer patients

The EXPERT clinical trial is investigating whether a genomic test of breast cancer tissue can be used to identify women with early breast cancer, who can safely avoid radiation therapy after breast cancer surgery and the potential side effects of this treatment. EXPERT is open to recruitment in Australia and New Zealand, and is the first trial developed by BCT researchers to be opened internationally. EXPERT is open in Spain, Switzerland, Italy, Argentina, Chile, Taiwan and Ireland.

Study Chair

Professor Boon Chua

FINER

Preventing the spread of hormone receptor-positive metastatic breast cancer

BCT is partnering with Canadian Cancer Trials Group researchers in the FINER study to evaluate whether the addition of ipatasertib to fulvestrant, compared with fulvestrant alone, is better at maintaining control and preventing growth of hormone receptor‑positive metastatic breast cancer. FINER closed to recruitment in June 2024 and we look forward to the findings of this research.

Study Chair

Associate Professor Andrew Redfern

Neo-N Cohort C

Supercharging treatment for triple negative breast cancer with dual immunotherapy

The original Neo-N trial examined whether a new drug called nivolumab helps control triple negative breast cancer when added to standard chemotherapy and found that 50% of patients on the trial had no evidence of breast cancer following treatment. Researchers are building on this finding with the Neo-N Cohort C trial, which will investigate if adding a new drug, relatlimab, given together with the nivolumab, can further control breast cancer when added to standard chemotherapy, for triple negative breast cancer patients.

Study Chair

Professor Sherene Loi

OLIO

Investigating a new treatment option for young women with the most common type of breast cancer

The OLIO trial aims to build on a breakthrough from a previous trial that discovered a feature in the tumours of young women with hormone receptor positive, HER2 negative breast cancer—the most common type of breast cancer, which can be more aggressive in premenopausal women. Tumours will be tested for a specific feature called HRD, which may render those tumours more sensitive to certain treatments. OLIO will test whether we can target this feature with the medicine olaparib to kill the cancer cells and if adding immunotherapy can provide the boost needed to prevent the cancer from returning. This trial aims to see if the addition of olaparib, or olaparib plus the immunotherapy drug durvalumab, in addition to standard chemotherapy before surgery, improves breast cancer outcomes in these high risk patients.

Study Chair

Dr Stephen Luen

OPTIMA

Identifying patients who may be able to avoid chemotherapy and the possible side effects from this treatment

People with intermediate to high-risk ER-positive, HER2-negative breast cancer are often offered both chemotherapy and hormone (endocrine) treatment to reduce the risk of the cancer coming back in the breast or elsewhere. Currently we don’t have a single test that can tell us whether or not someone in this situation might benefit from chemotherapy, and this treatment can have unpleasant short and long-term side-effects. There are now several tests which give more accurate information about individual breast cancers than the usual methods by looking at how active the genes are in breast cancer cells. OPTIMA aims to find out if using a test called Prosigna, can help make safe and accurate decisions about whether or not chemotherapy treatment is needed for patients with ER-positive, HER2-negative early breast cancer.

Study Chair

Dr Belinda Kiely

TUGETHER

Stopping the progression of HER2-positive metastatic breast cancer

The TUGETHER clinical trial is targeting HER2-positive metastatic breast cancer on multiple levels, in an attempt to slow and arrest the progression of this disease. TUGETHER combines the well-known anti-HER2 therapy trastuzumab, which works to block the HER2 receptors on the outside of cancer cells, with a new anti-HER2 therapy called tucatinib, which works by getting inside the cancer cells and blocking the growth signals sent by HER2 receptors. These two anti‑HER2 therapies will be combined with pembrolizumab, an immunotherapy drug that aids the body’s immune system to identify and kill cancer cells. It is hoped that the combination of these therapies will provide a new treatment approach for metastatic HER2-positive breast cancer.

Study Chair

Professor Sherene Loi