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.

 

EPIK-B3

Registered Title A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination With Nab-paclitaxel in Patients With Advanced Triple Negative Breast Cancer With Either Phosphoinositide-3-kinase Catalytic Subunit Alpha (PIK3CA) Mutation or Phosphatase and Tensin Homolog Protein (PTEN) Loss Without PIK3CA Mutation
Purpose  The purpose of this study is to determine whether treatment with alpelisib in combination
with nab-paclitaxel is safe and effective in subjects with advanced triple negative breast
cancer (aTNBC) who carry either a PIK3CA mutation (Study Part A) or have PTEN loss without
PIK3CA mutation (Study Parts B1 and B2)
Lay Summary   N/A
WA Trial Sites  Cancer Centre Clinical Trials Unit Ph. 08 615 26530
Links   US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

CAPTURE

Registered Title BCT 1901 (CAPTURE): A phase II randomised study to evaluate alpelisib plus fulvestrant versus capecitabine in oestrogen receptor positive, HER2-negative advanced breast cancer patients with PIK3CA mutant circulating DNA.
Purpose This study aims to find out whether treatment with alpelisib plus fulvestrant increases progression-free survival compared to capecitabine in women and men with eostrogen receptor positive (ER+), HER2-negative advanced breast cancer who have a PIKC3A mutation identified in circulating tumour DNA (ctDNA).
Lay Summary Who is it for?
This study may be suitable for you if you are 18 years or older, have advanced ER+, HER2-negative breast cancer, and have already had treatment with a CDK4/6 inhibitor and an aromatase inhibitor.
WA Trial Sites   Ph. (08) 6465 9204
Links  Australian New Zealand Clinical Trial Registry

Acknowledgments: Australian New Zealand Clinical Trial Registry

 

Neo-N

Registered Title BCT 2001 (Breast MRI Evaluation): Evaluation of clinical pathways and patient outcomes for breast magnetic resonance imaging (MRI) in preoperative assessment and staging of breast cancer: Establishing when MRI improves patient outcomes and when it does not. A multicentre prospective observational trial (Population B Prospective Study)
Purpose This study aims to find out how well using Nivolumab on its own before starting standard chemotherapy, or starting treatment with Nivolumab at the same time as standard chemotherapy, helps to reduce tumour size before surgery in patients with previously untreated early stage triple negative breast cancer
Lay Summary N/A 

WA Trial SItes

 

StJohn of God Hospital, Bunbury

Sites Australian New Zealand Clinical Trial Registry

Acknowledgments: Australian New Zealand Clinical Trial Registry

 

J2J-MC-JZLA

Registered Title A Phase 1a/1b Study of LY3484356 Administered as Monotherapy and in Combination With Abemaciclib to Patients With ER+, HER2- Locally Advanced or Metastatic Breast Cancer
Purpose EMBER: A Phase 1a/1b Study of LY3484356 Administered as Monotherapy and in Combination With Anticancer Therapies for Patients With ER+ Locally Advanced or Metastatic Breast Cancer and Other Select Non-Breast Cancers 
Lay Summary  N/A
WA Trial Sites

Linear Clinical Research Ph.  08 6382 5513

Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

GO40987

Registered Title   A Phase I, Multicenter, Open-Label Preoperative, Short-Term Window Study of GDC-9545 in Postmenopausal Women With Stage I-III Operable, Estrogen Receptor-Positive Breast Cancer
 Purpose This study will evaluate the pharmacodynamics, pharmacokinetics, safety, and biologic
activity of GDC-9545 in participants with Stage I-III operable estrogen receptor
(ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, untreated breast
cancer.
 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

 

BRCA-P

Registered Title
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, International Phase 3 Study to determine the Preventive Effect of Denosumab on Breast Cancer in Women carrying a BRCA1 Germline Mutation 
 Purpose  BRCA-P is an international breast cancer prevention clinical trial open to women with a confirmed BRCA1 gene mutation who have not had their breasts surgically removed. BRCA-P will investigate if using Denosumab is a safe and effective way of preventing breast cancer.
 Lay Summary  N/A
WA Trial Sites

Ph. (08) 6465 9204

 Links  N/A

 

DESTINY DS8201-A-U301

Registered Title  A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study of DS-8201a, an Anti-HER2-antibody Drug Conjugate, Versus Treatment of Investigator's Choice for HER2-positive, Unresectable and/or Metastatic Breast Cancer Subjects Pretreated With Prior Standard of Care HER2 Therapies, Including T-DM1
 Purpose  
Lay Summary This study will compare DS 8201a to standard treatment.Participants must have HER2 breast cancer that has been treated before.
WA Trial Sites

Ph. (08) 6465 9204

 Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

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
Ph. (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).
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  Ph. 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

Cancer Centre Clinical Trials Unit Ph.     (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

Ph. (08) 6500 5555

Link

Australian New Zealand Clinical Trials Registry

Acknowledgements: Australian New Zealand Clinical Trials Registry

 

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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