OUR CLINICAL TRIALS

Eight clinical trials were open to recruitment during the reporting period, from 1 April 2022 to 31 March 2023, with two new trials opening – DECRESCENDO and TUGETHER.

BRCA-P

Preventing breast cancer in women witha 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.

Breast MRI Evaluation Study

Evaluating the impact of MRI after diagnosis on treatment plans and patient outcomes

The Breast MRI Evaluation Study is looking at how having a breast MRI after being diagnosed with early-stage breast cancer might change plans for treatment and how this might affect patient outcomes. This study is addressing an Australian Government request to understand the best way to use MRI, when it will be most useful, and to find out if it can improve treatment options and patient outcomes. This trial completed recruitment in 2022 and we expect to have the first results available during 2023.

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

Identifying patients with HER2-positive early breast cancer who may be able to avoid extra chemotherapy

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). A total of 1065 participants will be enrolled over 30-36 months.

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 Herceptin. 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 is expected to be completed in 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, Argentina, Chile and Taiwan.

FINER

Targeting cellular growth pathways to tackle endocrine treatment resistance in hormone-receptor positive 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.

TUGETHER

Attacking HER2-positive metastatic breast cancer on multiple levels

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.