OUR CLINICAL TRIALS

Nine clinical trials were open to recruitment during the reporting period, from 1 April 2021 to 31 March 2022, and one new trial opened, FINER.

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.

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 Federal 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.

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.

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 prevent growth of hormone receptor positive metastatic breast cancer. This study opened in Australia in February 2022 and is expected to fully recruit the required 250 patients by the end of 2023.

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 investigator the optimal dose combination of both durvalumab and tremelimumab.

OPTIMISING IMMUNOTHERAPY TREATMENT FOR WOMEN AND MEN WITH TRIPLE NEGATIVE BREAST CANCER

The Neo-N clinical trial aims to identify more effective treatment options for early stage triple negative breast cancer patients, by combining an immunotherapy drug (nivolumab) together with chemotherapy (paclitaxel and carboplatin) prior to surgery. Often cancers can avoid detection and attack from the body’s immune system. This study will help us understand if nivolumab given for a short period on its own before commencing treatment with chemotherapy, can effectively activate the body’s anti-cancer immune response and contribute to better outcomes for triple negative breast cancer patients. Patients whose cancer responds well to this treatment may be able to avoid the short and long-term side effects of anthracycline-based chemotherapy, that would often be used for this type of breast cancer. This study closed to recruitment during the reporting period and we look forward to future results.

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 Spain, Switzerland, Argentina, Chile and Taiwan. It is anticipated that EXPERT will be opened in Italy in 2022.

PROVIDING TREATMENT OPTIONS FOR WOMEN AND MEN WITH METASTATIC BREAST CANCER

The PATINA clinical trial aims to find out if people with metastatic breast cancer could benefit from the addition of palbociclib, when given in combination with anti-HER2 therapy (trastuzumab and pertuzumab) and endocrine therapy. The study will investigate if the addition of palbociclib to first-line treatment of HER-2 positive metastatic breast cancer will delay the onset of therapeutic resistance and prolong survival, as well as find out more about the side effects, safety and effectiveness of the drug combination. PATINA reached its required recruitment target of 496 in 2021. We anticipate results to be available in 2022 or 2023.

AVOIDING TREATMENT TO THE ARMPIT FOR WOMEN WITH EARLY STAGE BREAST CANCER AND REDUCING THE POTENTIAL SIDE EFFECTS SUCH AS LYMPHOEDEMA

The POSNOC clinical trial is investigating axillary (armpit) treatment in women with early stage breast cancer who have metastases in one or two sentinel lymph nodes. Prior research suggests that it may be possible to avoid removal of all axillary nodes or radiotherapy to the armpit. It is hoped that patients may be spared the potential side effects of having extra treatment to the armpit including lymphoedema, pain and reduced arm movement. POSNOC reached its impressive international recruitment target of 1900 participants in 2021 with the final two participants of the coming from BCT. Follow up of all trial participants will continue with results are anticipated in the coming years.