Breast

The following list provides a brief description of breast cancer trials that are open for recruitment in Western Australia. If you would like more information please follow the links provided, contact one of the trial sites or speak with your doctor.

Please note that this list is based on information provided to the Cancer Council by WA hospitals and may not include all clinical trials that are running in WA.

Where ‘N/A' appears - this means the lacking information has not been provided to date to the Cancer Council.

 

PATINA / BCT 1701

Registered Title A Randomized, Open Label, Phase III Trial to Evaluate the Efficacy and Safety of Palbociclib + Anti-HER2 Therapy + Endocrine Therapy vs. Anti-HER2 Therapy + Endocrine Therapy After Induction Treatment for Hormone Receptor Positive (HR+)/HER2-Positive Metastatic Breast Cancer
Purpose The primary objective of this study is to demonstrate that the combination of palbociclib with anti-HER2 therapy plus endocrine therapy is superior to anti-HER2-based therapy plus endocrine therapy alone in improving the outcomes of subjects with hormone receptor positive, HER2+ metastatic breast cancer.
Lay Summary  N/A
WA Trial Sites

Breast Cancer Research Centre WA (08) 6500 5555

Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

IPATunity 130 / CO40016

Registered Title  A Double-Blind, Placebo-Controlled, Randomized Phase III Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Patients With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer
Purpose  This study will evaluate the efficacy of ipatasertib + paclitaxel versus placebo + paclitaxel
in participants with histologically confirmed, locally advanced or metastatic triple-negative
breast cancer (TNBC) and in participants with locally advanced or metastatic hormone receptor
positive (HR+)/ human epidermal growth factor receptor 2 negative (HER2-) breast
adenocarcinoma who are not suitable for endocrine therapy.
Lay Summary  N/A
WA Trial Sites  Cancer Centre Clinical Trials Unit
Phone 08 615 26530
Links  US National Library of Medicine
Acknowledgements: US National Library of Medicine

 

IMLYGIC

Registered Title A Phase 1b Study of Talimogene Laherparepvec in Combination With Atezolizumab in Subjects With Triple Negative Breast Cancer and Colorectal Cancer With Liver Metastases
Purpose Approximately 36 subjects will be enrolled in this study. The locations of the study will be
in the United States, Australia, Europe and Switzerland.

The goal of this study is to evaluate the safety of intrahepatic injection (directly into the
liver) of talimogene laherparepvec in combination with intravenously administered
atezolizumab in subjects with triple negative breast cancer and colorectal cancer with liver
metastases.

Lay Summary  N/A
WA Trial Sites

 Cancer Centre Clinical Trials Unit
Phone 08 615 26530

Breast Cancer Research Centre WA (08) 6500 5555

Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

EMBRACE

Registered Title Phase II clinical trial of the PARP inhibitor, olaparib, in HR-deficient metastatic breast and relapsed ovarian cancer in patients without germline mutations in BRCA1 and BRCA2: The EMBRACE study
Purpose This study is testing olaparib, in Homologous recombination (HR) deficient metastatic breast and relapsed ovarian cancer in patients who do not have hereditary mutations in BReast CAncer susceptibility gene 1 and gene 2 (BRCA1 and BRCA2).

Who is it for?
You may be eligible to join this study if you are aged 18 years or above and are either: a) men or women with confirmed evidence of metastatic triple negative breast cancer OR b) women with confirmed evidence of relapsed high grade serous ovarian cancer or high grade endometrioid ovarian cancer

Study details
All study participants will take olaparib 300 mg orally twice daily until disease progression or unacceptable toxicity. Assessments for safety and efficacy will be followed up for a minimum of 6 months

Olaparib, has been approved overseas and in Australia in women shown to have inherited changes in their BRCA1 or 2 genes. There is strong evidence to show that olaparib will also work in people who do not have any changes in their genes. The purpose of this study is to assess whether the olaparib is effective in treating these tumours.

Lay Summary  N/A
WA Trial Sites  Cancer Centre Clinical Trials Unit
Phone 08 615 26530
Links  Australian New Zealand Clinical Trial Registry

Acknowledgments: Australian New Zealand Clinical Trial Registry


OBI 822-011

Registered Title A Phase III, Randomized, Double-blind, Placebo Controlled Study of Adagloxad Simolenin (OBI 822)/OBI 821 Treatment for High Risk Early Stage Triple Negative Breast Cancer Patients, Defined as Residual Invasive Disease Following Neoadjuvant Chemotherapy OR =4 Positive Axillary Nodes
Purpose  This is a Phase III, randomized, double-blind, placebo controlled, study to prospectively
evaluate the efficacy and safety of adagloxad simolenin (OBI 822)/OBI-821 treatment, compared
to placebo, in patients with early stage TNBC at high risk for recurrence.
Lay Summary  N/A
WA Trial Sites  Murdoch Oncology Clinical Trials Unit
Ph. (08) 9428 8539
Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

NATALEE / CLEE011O12301C

Registered Title A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer
Purpose  A phase III multi-center, randomized, open-label trial to evaluate efficacy and safety of ribociclib with endocrine therapy as adjuvant treatment in patients with HR+/HER2- Early Breast Cancer
Lay Summary  N/A
WA Trial Sites

 Cancer Centre Clinical Trials Unit
Phone 08 615 26530

Clinical Trials Unit Ph. (08) 6500 5555

Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine


DIAmOND / BCT 1703

Registered Title BCT 1703 (DIAmOND): An investigator-initiated, non-randomised, phase II study of combination CTLA-4 and PD-L1 blockade in advanced HER2-positive breast cancers who have progressed on prior trastuzumab-based therapy.
Purpose "This study aims to find out if the combination of trastuzumab (anti-HER2 therapy) with durvalumab (PD-L1 inhibitor) and tremelimumab (CTLA4 inhibitor) will reactivate anti-tumour immune response and improve clinical outcomes in trastuzumab-resistant, advanced HER2-positive breast cancer.
Lay Summary  N/A
WA Trial Sites

 Fiona Stanley Hospital

Cancer Centre Clinical Trials Unit (08) 615 26530

Links  Australian New Zealand Clinical Trial Registry

Acknowledgments: Australian New Zealand Clinical Trial Registry

 

EXPERT

Registered Title A randomised phase III trial of adjuvant radiation therapy versus observation following breast conserving surgery and endocrine therapy in patients with molecularly characterised luminal A early breast cancer
Purpose  This is a randomised, phase III, non-inferiority trial evaluating radiation therapy versus observation following breast conserving surgery and planned endocrine therapy in patients with stage I breast cancer of luminal A subtype defined using the Prosigna (PAM50) Assay.
Lay Summary  N/A
WA Trial Sites

SCGH - Radiation Oncology (08) 6383 3204

Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

AREA Study

Registered Title

Randomised study to evaluate the impact of Aerobic and Resistance Exercise on fatigue in patients with advanced breast cancer (AREA study).

Purpose

The study will assess the feasibility of a specified exercise program in patients with advanced breast cancer and its impact on improving fatigue.

Lay Summary

Who is it for?

You may be eligible to join this study if you are a female with metastatic breast cancer aged between 18-80 years, and are being managed at the Mount Hospital, Perth, WA. Eligible women will also have experienced subjective fatigue in the past several weeks as a persistent symptom.

Study details:

This study will be conducted in two parts. In Part 1, eligible patients will be offered a 6 week exercise program, where the primary endpoint will be to assess feasibility and overall safety. If the program is deemed as being feasible and safe, Part 2 of the study will commence. In Part 2, participants will be randomly (by chance) allocated to one of two groups. Participants in one group will be offered the 6 week exercise program, whilst participants in the other group will not participate in the exercise program. On completion of the program, participants will be asked to complete some questionnaires to assess their levels of fatigue, depression and pain. They will also be asked to conduct a brief walking test to assess any changes in aerobic fitness.

WA Trial Sites

Breast Clinical Trials Unit Logo

Conducted at Breast Clinical Trials Unit
Ph. (08) 6500 5555

Link

Australian New Zealand Clinical Trials Registry

Acknowledgements: Australian New Zealand Clinical Trials Registry

 

POSNOC Study

Registered Title

POSNOC - POsitive Sentinel NOde: Adjuvant Therapy Alone Versus Adjuvant Therapy Plus Clearance or Axillary Radiotherapy. A Randomised Controlled Trial of Axillary Treatment in Women With Early Stage Breast Cancer Who Have Metastases in One or Two Sentinel Nodes.

Purpose

POSNOC is a pragmatic, randomised, multicentre, non-inferiority trial. For women with early stage breast cancer and one or two sentinel node macrometastases, to assess whether adjuvant therapy alone is no worse than adjuvant therapy plus axillary treatment, in terms of axillary recurrence within 5 years.

Lay Summary

N/A

WA Trial Sites

 

 

 


SCGH Radiation Oncology
Ph. (08) 6383 3000

 

St John of God
Ph. (08) 6465 9204
GenesisCare

For more information about trials with GenesisCare in Western Australia, phone 1300 977 062 and ask to speak to one of the trials coordinators, or speak to your GenesisCare radiation oncologist.

Links

US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

Local Her-O

Registered Title A Phase II study of local therapy only (stereotactic radiosurgery and/or surgery) for treatment of up to 5 brain metastases from HER2 positive Breast Cancer
Purpose  This study aims to show that brain metastases from Human Epidermal Growth Factor Receptor Type 2 (HER2) positive breast cancers are able to be controlled by local therapies, Stereotactic Radiosurgery (SRS) and/or Neurosurgery (NS), without the need for Whole Brain Radiotherapy (WBRT).
Lay Summary  N/A
WA Trial Sites

SCGH - Radiation Oncology (08) 6383 3204

Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

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