Breast

he 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.

 

CORE (TROG 16.03)

Registered Title A Randomised Trial of COnventional Care Versus Radioablation (Stereotactic Body Radiotherapy) for Extracranial Oligometastases 
 Purpose The CORE study aims to understand whether there is a benefit in adding a type of radiotherapy called Stereotactic Body Radiation Therapy (SBRT) to the standard treatment in people with breast, prostate, or non-small cell lung cancer (NSCLC) which has spread to 3 or less areas of the body (known as oligometastatic disease).
 Lay Summary  Assessing the benefit of targeted radiotherapy added to standard of care in the management of isolated metastases outside the brain.
 WA Trial Sites

SCGH - Radiation Oncology (08) 6383 3204

 Links  US National Library of Medicine

Acknowledgements:US National Library of Medicine

 

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

 

PALLAS

Registered Title

Study Number AFT-05/ABCSG 42/BIG 14-03

PALbociclib CoLlaborative Adjuvant Study: A Randomized Phase III Trial of Palbociclib With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone for Hormone Receptor Positive (HR+) / Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Early Breast Cancer

Purpose

The purpose of the PALLAS study is to determine whether the addition of palbociclib to adjuvant endocrine therapy will improve outcomes over endocrine therapy alone for HR+/HER2- early breast cancer. Assessment of a variety of correlative analysis, including evaluation of the effect of palbociclib in genomically defined tumor subgroups, is planned.

Lay Summary

N/A

WA Trial Sites

Breast Clinical Trials Unit Logo

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

 Cancer Centre Clinical Trials Unit

(08) 615 26530

Link

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

 

ATTAIN

Registered Title

A Phase 3 Open-Label, Randomized, Multicenter Study of NKTR-102 Versus Treatment of Physician's Choice (TPC) in Patients With Metastatic Breast Cancer Who Have Stable Brain Metastases and Have Been Previously Treated With an Anthracycline, a Taxane, and Capecitabine

Purpose

N/A

 

Lay Summary

This is an open-label, randomized, active comparator, multicenter, international Phase 3 study of NKTR-102 versus TPC in patients with metastatic breast cancer who have stable brain metastases and have been previously treated with an anthracycline, a taxane, and capecitabine in either the adjuvant or metastatic setting (prior anthracycline may be omitted if medically appropriate or contraindicated for the patient).

WA Trial Sites

St John of God - Subiaco (08) 6465 9204

 

US National Library of Medicine

 

LEE2107

Registered Title

A Phase Ib/II, Multicenter Study of the Combination of LEE011 and BYL719 With Letrozole in Adult Patients With Advanced ER+ Breast Cancer

Purpose

The purpose of this trial is to inform the future clinical development of the two investigational agents in ER+ breast cancer, LEE011 (CDK4/6 inhibitor) and BYL719 (PI3K-alpha inhibitor).

This is a multi-center, open-label Phase Ib study. The Phase Ib dose escalation will estimate the MTD and/or RP2D for three regimens: two double combinations, LEE011 with letrozole and BYL719 with letrozole, followed by triple combinations of LEE011 + BYL719 with letrozole (Arms 3 and 4).

The Phase Ib dose escalation part will be followed by Phase Ib dose expansions to further characterize the safety, tolerability, PK and preliminary clinical anti-tumor activity of the combinations. Optional crossover for patients who have progressed while on dose escalation or dose expansion with doublet treatment on Arms 1 or 2 to be treated with the triplet combination (Arm 3) after the determination of the RP2D for Arm 3; is no longer permitted after protocol amendment 6.

Approximately 250 adult women with ER+/HER2- locally advanced or metastatic breast cancer will be enrolled.

Lay Summary

N/A

WA Trial Sites

Breast Clinical Trials Unit Logo

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

Link

US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

Monarch E

Registered Title

A Randomized, Open-Label, Phase 3 Study of Abemaciclib Combined With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone in Patients With High Risk, Node Positive, Early Stage, Hormone Receptor Positive, Human Epidermal Receptor 2 Negative, Breast Cancer

Purpose

N/A

Lay Summary

N/A

WA Trial Sites

Breast Clinical Trials Unit Logo

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

 

St John of God - Subiaco (08) 6465 9204

Link

US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

IPATunity 130

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

Fiona Stanley Hospital Logo

Cancer Centre Clinical Trials Unit
Caroline Stone
Clinical Trials Manager
Phone 08 615 26530 Fax 08 615 20954
caroline.stone@health.wa.gov.au

Links

US National Library of Medicine 

Acknowledgements: US National Library of Medicine


PATINA

 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 Subjects will be randomized into one of two treatment arms following minimum of 4 and maximum of 8 cycles of induction treatment with anti-HER2 therapy. Arm A subjects will receive the experimental therapy, palbociclib, in addition to their current anti-HER2 therapy and endocrine therapy. Arm B subjects will continue to receive the anti-HER2 therapy. It is expected that the addition of palbociclib to the first-line treatment of HER2 disease will delay the onset of therapeutic resistance and ultimately prolong the survival of patients with metastatic breast cancer. The study is designed to treat the subset of patients with HER2+ disease who are also hormone receptor positive (HR+). It is also expected that palbociclib will modulate the endocrine resistance in HER2+/HR+ disease and potentiate the benefits of anti-HER2 therapy. Lastly, the current study includes a comprehensive molecular characterization of the disease at study entrance which will allow us to investigate the benefits of palbociclib in subsets of HER2+/HR+ disease such as PIK3CA mutant.
 Lay Summary
 N/A
 WA Trial Sites

 

Breast Cancer Research Centre WA (08) 6500 5555

   US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

NEKTAR

Registered Title

 A Phase 3 Open-Label, Randomized, Multicenter Study of NKTR-102 Versus Treatment of Physician's Choice (TPC) in Patients With Metastatic Breast Cancer Who Have Stable Brain Metastases and Have Been Previously Treated With an Anthracycline, a Taxane, and Capecitabine

Purpose

 

This is an open-label, randomized, active comparator, multicenter, international Phase 3 study of NKTR-102 versus TPC in patients with metastatic breast cancer who have stable brain metastases and have been previously treated with an anthracycline, a taxane, and capecitabine in either the adjuvant or metastatic setting (prior anthracycline may be omitted if medically appropriate or contraindicated for the patient).

Lay Summary

N/A

WA Trial Sites

Breast Clinical Trials Unit Logo

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

Link

US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

 

Her2Climb

Registered Title

 Phase 2 Randomized, Double-Blinded, Controlled Study of Tucatinib vs Placebo in Combination With Capecitabine and Trastuzumab in Patients With Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Carcinoma (HER2CLIMB)

Purpose

 

A randomized, international, multi-center, double-blinded study in patients with progressive unresectable locally advanced or metastatic HER2+ breast cancer who have had prior treatment with trastuzumab, pertuzumab and T-DM1. Patients will be randomized in a 2:1 ratio to receive tucatinib or placebo in combination with capecitabine and trastuzumab.

Stratification factors include presence or history of treated or untreated brain metastases (yes/no), Eastern Cooperative Oncology Group Performance Status (ECOG PS) (0 vs. 1), and region of world (US vs Canada vs Rest of World).

Lay Summary

 

WA Trial Sites

Breast Clinical Trials Unit Logo

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

Link

US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

 

OLYMPIA Study

Registered Title

A Randomised, Double-blind, Parallel Group, Placebo-controlled Multi-centre Phase III Study to Assess the Efficacy and Safety of Olaparib Versus Placebo as Adjuvant Treatment in Patients With germline BRCA1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy.

Purpose

Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy.

Lay Summary

N/A

WA Trial Sites

Sir Charles Gairdner Hospital Logo

SCGH Medical Oncology
Ph. (08) 6383 3000

Links

US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

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 Healthcare logo

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

 

PUMA-NER-6201

Registered Title

An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Intensive Loperamide Prophylaxis.

Purpose

The primary objective of this study is to characterize the incidence and severity of diarrhea in patients with early-stage HER2 overexpressed/amplified (HER2+) breast cancer treated with neratinib when administered with intensive loperamide prophylaxis, after prior treatment with trastuzumab.

Lay Summary

N/A

WA Trial Sites

Breast Clinical Trials Unit Logo

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

Link

US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

T-VEC liver mets

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

Breast Cancer Research Centre WA (08) 6500 5555

FSH - Cancer Centre Clinical Trials Unit (08) 615 26530

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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