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.

Natalie Walsh
Clinical Trials Coordinator
SVHS.CancerResearch@svha.org.au

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

TRAIL

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

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

SERENA-6 (ER/PR+ HER2-)

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

EMBER-3 (ER/PR+ HER2-)

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

CAPITELL0-292 (ER/PR+ HER2-)

A study of capivasertib, palbociclib and fulvestrant for advanced hormone receptor positive breast cancer.

Requirements: This study is for adults with advanced breast cancer that is positive for the oestrogen receptor, positive or negative for the progesterone receptor, negative for the HER2 receptor.

Reference: 2021-04-453

PH1 RLY-4008 [REFOCUS] (ER+)

A study of FGFR2 inhibitor (RLY-4008) in advanced solid tumours including ER+ breast cancer.

Requirements: Patients with ER+ breast cancer, with a FGFR2 gene alteration that is not responsive to standard therapy. Patients must have completed prior adjuvant/neo-adjuvant at least 6 months prior, with one cycle of chemotherapy allowed during screening.

Reference: 2021/ETH00355

PH1 4-CAST (TNBC)

A study of seviteronel and dexamethasone (SEVI-D) in combination with docetaxel in androgen receptor (AR) positive triple-negative breast cancer.

Requirements: Patients with tiple negative advanced or recurrent breast cancer for whom docetaxel is considered an appropriate treatment.

Reference: 2020/ETH03307

PH1- MK-7399-002 [LYNK-002]

A study of olaparib (MK-7339) monotherapy in participants with advanced breast cancer

Requirements: Patients who have advanced or metastatic breast cancer that are positive for homologous recombination repair mutation (HRRm) or homologous recombination deficiency (HRD). Patients with hormone receptor positive breast cancer must have progressed on at least one line of endocrine therapy or be unsuitable for endocrine therapy.

Reference: HREC/18/SVH/258

PH1- XL092 [STELLAR-001] (ER/PR+ HER2-)

A study of XL092, alone or in combination therapy, in patients with locally advanced or metastatic breast cancer.

Requirements: Patients who have hormone receptor positive, HER2 negative, locally advanced or metastatic breast cancer who have completed at least one prior line of systemic therapy.

Reference: 2021/ETH11531

PH1- LOXO PIK 21001 [PIKASSO-01] (ER/PR+ HER2-)

A study of LOXO-783 alone or in combination therapy, in patients with advanced breast cancer with a PIK3CA H1047R mutation.

Requirements: Patients who have advanced breast cancer with a PIK3CA H1047R mutation as above; up to 5 prior lines of treatment are allowed.

Reference: 2022/ETH00707

PH1- AK-127 101 (TNBC)

A study of AK127 in combination with AK104 in patients with advanced or metastatic breast cancer.

Requirements: Patients who have received no more than three prior lines of systemic therapy.

Reference: 2021/ETH12026

PH1- BGB A317 (TNBC)

A study of BCB-10188 (a PI3K Inhibitor) in combination with tislelizumab (anti-PD1) in advanced breast cancer.

Requirements: Patients with locally advanced or metastatic solid tumour breast cancer that has been previously treated with standard systemic therapy, and is responsive to anti-PD1 therapy.

Reference: 2019/ETH13731

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.