Breast cancer clinical trials

Our researchers are conducting a number of clinical trials for breast cancer at the Kinghorn Cancer Centre. The current trials are looking for patients with early, advanced-stage breast cancer and patients that are undergoing breast cancer surgery. 

All trials are held at The Kinghorn Cancer Centre, Darlinghurst NSW.

The eligibility criteria to participate in these trials can be complex and varies on a case by case basis. Please discuss any potential clinical trials with your primary oncologist, specialist or GP. Both you and your treating doctor are welcome to phone or email the clinical trials team with any questions. Once you are ready to discuss potential trials in person or via telehealth, you will need a referral from your treating doctor to see one of our oncologists at the Kinghorn Cancer Centre (St Vincent’s Hospital Sydney).

Contact us for further information, to see if you're eligible for treatment, or to enquire about an upcoming trial.


Contact us for further information, to see if you're eligible for treatment, or to enquire about an upcoming trial.

Natalie Walsh
Clinical Trials Coordinator

Ph: (02) 9355 5723
Fax: (02) 8382 2660



Early stage breast cancer

WinPro window study with prometrium (ER+/PR+)

A study of endocrine therapy with progesterone in post-menopausal women with early-stage hormone receptor positive breast cancer, prior to undergoing breast surgery.

Requirements: post-menopausal women with early-stage breast cancer which is estrogen and progesterone receptors positive, HER2 receptor negative, a tumour size of ≥1cm and have not yet had breast surgery.

Reference: HREC/17/SVH/255

OBI-822 Adagloxad Simolenin Vaccine trial (TNBC)

A study of adjuvant Adagloxad Simolenin (novel immuno-oncology vaccine) treatment for high risk early stage triple negative breast cancer.

Requirements: early stage triple negative breast cancer (oestrogen/progesterone receptors and HER2 negative), has residual invasive disease following neoadjuvant chemotherapy or ≥4 axillary lymph node involvement and received adjuvant chemotherapy.

Reference: HREC/18/SVH/198


A study to determine if breast cancer genetic material (known as circulating tumour DNA (ctDNA)) can be detected in the bloodstream. It is hoped that this research will demonstrate the utility of this circulating material as an early marker of residual or recurrent breast cancer activity after treatment. 

Requirements: Patients with non-metastatic early breast cancer.

Reference: HREC/43163/PMCC-2018

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Advanced stage breast cancer

CAPTURE with alpelisib and fulvestrant (ER+)

A randomised study of oral PI3K inhibitor alpelisib with fulvestrant versus capecitabine for advanced ER+ breast cancer with PIK3CA mutation found on circulating tumour DNA test.

Requirements: Patients with advanced breast cancer, which is oestrogen receptor positive and HER2 receptor negative, and has PIK3CA mutation as above; up to 2 prior lines endocrine therapy and 1 prior line of chemotherapy allowed.

Reference: HREC/57079/PMCC-2019



A study of AZD9833 in combination with CDK4/6 inhibitor (palbociclib or abemaciclib), compared to current standard therapy of an aromatase inhibitor (anastrozole or letrozole) in combination with CDK4/6 inhibitor (palbociclib or abemaciclib) in patients with hormone receptor positive, HER2-negative metastatic breast cancer with a detectable ESR1 mutation.

Requirements: Patients with hormone receptor positive, HER2-negative, metastatic breast cancer with a detectable ESR1 mutation who are currently on treatment receiving aromatase inhibitor (letrozole or anastrozole) and a CDK4/6 inhibitor (palbociclib or abemaciclib) as the initial endocrine based treatment for advanced breast cancer.

Reference: HREC/77091/SVHM


A study of standard hormone therapy (exemestane or fulvestrant) compared to either imlunestrant with abemaciclib, or imlunestrant alone, in advanced/metastatic breast cancer that is ER+ and HER2-negative.


Requirements: Patients with ER+, HER2- locally advanced or metastatic breast cancer who have demonstrated progression on or after an aromatase inhibitor alone or in combination with a cyclin-dependent kinase (CDK)4/6 inhibitor.

Reference: HREC 234/21

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All patients undergoing breast surgery at St Vincent's Hospital

All patients undergoing breast surgery at St Vincent's Hospital

Project SHARE (Specimens Help All Research Efforts)

We invite all patients undergoing breast surgery at St Vincent’s Hospital to partner with us in our research endeavours. Tissue that is routinely collected at the time of surgery and in excess of diagnostic requirements will be brought to the laboratories at the Garvan Institute, enabling many researchers use these tissues as building blocks for their research.