Our Clinical Trials

Eight clinical trials were open to recruitment during the reporting period, from 1 April 2023 to 31 March 2024, with one new trial opening called OPTIMA.

The OPTIMA clinical trial opened in early 2024 and aims to identify some patients who may be able to avoid chemotherapy.

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 will investigate 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 will investigate whether Denosumab decreases the risk of developing ovarian cancer or other types of cancers. The study will also assess its effect on bone health, patient-reported outcomes, side effects and biological markers. Recruitment is expected to be completed in 2024.

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, can benefit from a new drug, 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 resistance to these therapies. Mutations in the PIK3CA gene of cancer cells can be identified through a specialised blood test for circulating tumour DNA. The study will investigate 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.

DECRESCENDO: REDUCING CHEMOTHERAPY FOR SOME PATIENTS WITH HER2-POSITIVE EARLY BREAST CANCER

DECRESCENDO is aiming to identify patients whose early-stage, HER2-positive breast cancer may be sufficiently treated with a combination of pertuzumab and trastuzumab (anti-HER2 therapy) and taxane chemotherapy only and avoid the need for treatment with traditional chemotherapy drugs. Patients will receive dual anti-HER2 therapy with taxane chemotherapy prior to breast surgery. Those patients who have no remaining cancer at the time of surgery will continue to be treated with dual anti-HER2 therapy and avoid any further treatment involving chemotherapy. Those patients with breast cancer remaining at the time of surgery will go on to receive traditional chemotherapy treatment. DECRESCENDO is an international clinical trial being managed by BCT in partnership with Institut Jules Bordet (IJB) and the Breast International Group (BIG). Recruitment closed in July 2023.

DIAmOND: ADDING IMMUNOTHERAPY TO TREATMENT TO IMPROVE OUTCOMES FOR PATIENTS WITH METASTATIC BREAST CANCER

The DIAmOND clinical trial has been developed by BCT researchers who are hoping to identify a new immunotherapy treatment option for patients who have metastatic HER2-positive breast cancer. The trial will investigate the addition of two immune monoclonal antibodies (durvalumab and tremelimumab) to trastuzumab. This drug combination has been given previously to people with lung cancer and this is the first clinical trial that will test the combination of these two drugs in people with breast cancer. The study was expanded in 2021 to investigate the optimal dose combination of both durvalumab and tremelimumab. Recruitment to DIAmOND was completed in December 2023.

EXPERT: USING A GENOMIC TEST TO IDENTIFY WOMEN WITH EARLY BREAST CANCER WHO MAY BE ABLE TO AVOID RADIATION THERAPY

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 the first trial developed by BCT researchers to be opened internationally. EXPERT is open in Australia, New Zealand, Spain, Switzerland, Italy, Argentina, Chile and Taiwan. EXPERT was opened in Ireland in 2024.

FINER: PREVENTING GROWTH OF HORMONE RECEPTOR-POSITIVE METASTATIC BREAST CANCER

BCT has partnered 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. This study opened in Australia in February 2022 and is being conducted in 23 institutions throughout Australia and New Zealand. Recruitment to FINER is expected to be completed in 2024.

OPTIMA: USING A GENOMIC TEST TO IDENTIFY IF SOME PATIENTS MAY BE ABLE TO AVOID CHEMOTHERAPY

People with ER-positive, HER2-negative breast cancer are usually 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 might benefit from chemotherapy, so some people may receive chemotherapy who don’t need it. Chemotherapy 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. These tests use a sample of the cancer (tissue sample) already removed by at surgery. We need to do more research to understand how best to use these tests. Some research that has already been done suggests that the tests could be used to find patients who don’t need chemotherapy. Giving less treatment with the same or better results is called optimised treatment. OPTIMA has been open in the UK, Sweden and Norway since 2017. The study aims to recruit 4,500 participants and BCT will contribute around 300 participants from 50 sites across Australia and New Zealand.

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 will combine 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 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. TUGETHER will recruit 50 patients from 16 institutions across Australia.