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.

 

DESTINY-Breast05

Registered Title  A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in Participants With High-Risk HER2-Positive Primary Breast Cancer Who Have Residual Invasive Disease in Breast or Axillary Lymph Nodes Following Neoadjuvant Therapy (DESTINY-Breast05)
 Purpose  Patients with HER2-positive primary breast cancer (BC) who do not achieve complete response
after appropriate neoadjuvant therapy are at higher risk of disease recurrence. More
effective treatment options are needed for this patient population. This study will examine
the efficacy and safety of trastuzumab deruxtecan (T-DXd) compared with trastuzumab emtansine
(T-DM1) in high-risk patients with residual invasive breast cancer following neoadjuvant
therapy.
Lay Summary  N/A
WA Trial Sites   Ph. (08) 6465 9204
 Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

DESTINY-PanTumor02

Registered Title  A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors (DESTINY-PanTumor02)
 Purpose This is an open-label, multi-center, multi-cohort, Phase 2 study to evaluate the efficacy and
safety of trastuzumab deruxtecan (T-DXd) for the treatment of selected HER2-expressing
tumors.
Lay Summary  N/A
WA Trial Sites  Ph. 08 6382 5513
 Links US National Library of Medicine 

Acknowledgements: US National Library of Medicine

 

MORPHEUS- BREAST CANCER

Registered Title  A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Breast Cancer
 Purpose This is a Phase Ib/II, open-label, multicenter, randomized umbrella study in participants
with breast cancer. The current cohort (Cohort 1) will focus on participants with inoperable,
locally advanced or metastatic, estrogen receptor (ER)-positive breast cancer who had disease
progression during or following treatment with a cyclin-dependent kinase 4/6 inhibitor
(CDK4/6i; e.g., palbociclib, ribociclib, abemaciclib) in the first- or second-line setting.
The study is designed with the flexibility to open new treatment arms as new treatments
become available, close existing treatment arms that demonstrate minimal clinical activity or
unacceptable toxicity, or modify the patient population.
 Lay Summary  N/A
WA Trial Sites  Ph. 08 6382 5513
 Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

C042177

Registered Title  A Phase Ib, Open-Label, Multicohort Study of the Safety, Efficacy, and Pharmacokinetics of Tiragolumab in Combination With Atezolizumab and Chemotherapy in Patients With Triple-Negative Breast Cancer
Purpose The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of
tiragolumab in combination with atezolizumab and chemotherapy in participants with metastatic
and early triple-negative breast cancer (TNBC).
Lay Summary  N/A
WA Trial Sites   Oncology Ph: (08) 9428 8556
Links US National Library of Medicine 
Acknowledgements: US National Library of Medicine

 

 

CONTESSA TRIO

Registered Title   A Multicenter, Phase 2 Study of Tesetaxel Plus 3 Different PD-(L)1 Inhibitors in Patients With Metastatic TNBC and Tesetaxel Monotherapy in Elderly Patients With HER2 Negative MBC
Purpose  CONTESSA TRIO is a 2-cohort, multicenter, Phase 2 study of tesetaxel, an investigational,
orally administered taxane. In Cohort 1, approximately 90 patients (with potential expansion
to up to 150 patients) with locally advanced or metastatic triple-negative breast cancer
(TNBC) who have not received prior chemotherapy for advanced disease.
Lay Summary  N/A
WA Trial Sites  Ph. (08) 6500 5555
 Links US National Library of Medicine 

Acknowledgements: US National Library of Medicine

 

Breast MRI Evaluation

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 if having a breast MRI after being diagnosed with breast cancer might change plans for treating the breast cancer and how this might affect patient outcomes.
Lay Summary  N/A
WA Trial Sites

 Breast assessment clinic

Oncology - Ph 92248055 

  Ph. (08) 6465 9204

Links Australian New Zealand Clinical Trial Registry 
Acknowledgments: Australian New Zealand Clinical Trial Registry

 

POSNOC

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

 Breast Assessment Clinic

Radiation Oncology Ph: (08) 6383 3204

Ph. (08) 6465 9204

 Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

ACT16105

Registered Title   An Open Label Randomized Phase 2 Trial of SAR439859, Versus Endocrine Monotherapy as Per Physician's Choice in Premenopausal and Postmenopausal Patients With Estrogen Receptor-positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer With Prior Exposure to Hormonal Therapies
 Purpose

To determine whether SAR439859 per os improves progression free survival (PFS) when compared
with an endocrine monotherapy of the choice of the physician, in participants with metastatic
or locally advanced breast cancer.

 Lay Summary  N/A
 WA Trial Sites  Breast Cancer Research Centre WA Ph. (08) 6500 5555
 Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

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

  Oncology Clinical Trials Unit - Ph. (08) 9428 8556

Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

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

 

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

 

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