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.

 

 

Abbvie M12-914 Trial

Registered Title

A Phase 3 Randomized, Placebo-controlled Trial of Carboplatin and Paclitaxel With or Without the Poly ADP-ribose Polymerase (PARP) Inhibitor Veliparib (ABT-888) in Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Metastatic or Locally Advanced Unresectable Breast Cancer Gene (BRCA)-Associated Breast Cancer.

Purpose

The study seeks to evaluate the efficacy and tolerability of veliparib/placebo in combination with carboplatin and paclitaxel in HER2-negative metastatic or locally advanced, unresectable, BRCA-associated breast cancer.

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

 

 

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

Link

US National Library of Medicine

 

Eli Lilly 13Y-MC-JPBO

Registered Title

A Phase 2 Study of Abemaciclib in Patients With Brain Metastases Secondary to Hormone Receptor Positive Breast Cancer, Non-small Cell Lung Cancer, or Melanoma.

Purpose

The main purpose of this study is to evaluate the safety and effectiveness of the study drug known as abemaciclib in participants with hormone receptor positive breast cancer, non-small cell lung cancer (NSCLC), or melanoma that has spread to the brain.

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

 

 

Eli Lilly 13Y-MC-JPBZ (MonarcHER)

Registered Title

monarcHER: A Phase 2, Randomized, Multicenter, 3-Arm, Open-Label Study to Compare the Efficacy of Abemaciclib Plus Trastuzumab With or Without Fulvestrant to Standard-of-Care Chemotherapy of Physician's Choice Plus Trastuzumab in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer.

Purpose

The purpose of this study is to evaluate the effectiveness of abemaciclib plus trastuzumab with or without fulvestrant or chemotherapy in women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 positive (HER2+) locally advanced or metastatic breast cancer after prior exposure to at least two HER2-directed therapies for advanced disease.

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

 

 

ELIMINATE Study

Registered Title

Randomised phase II trial of neoadjuvant chemotherapy +/- concurrent aromatase inhibitor endocrine therapy to down-stage large oestrogen receptor positive breast cancer.

Purpose

This study aims to add hormone treatment (aromatase inhibitor (letrozole)) to standard neoadjuvant chemotherapy and find out if this treatment is more effective in reducing the size of large breast cancers before surgery. More effective down-staging of large breast cancers before surgery increases the likelihood of achieving a complete surgical resection and can increase the rate of breast conserving surgery.

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

Australian New Zealand Clinical Trials Registry

Acknowledgements: Australian New Zealand Clinical Trials Registry


KEYNOTE-522

 Registered Title
A Phase III, Randomized, Double-blind Study to Evaluate Pembrolizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy for Triple Negative Breast Cancer (TNBC)
 
 Purpose  The purpose of this study is to evaluate the efficacy and safety of pembrolizumab (MK-3475) plus chemotherapy vs placebo plus chemotherapy as neoadjuvant therapy and pembrolizumab vs placebo as adjuvant therapy in participants who have triple negative breast cancer (TNBC). After a screening phase of approximately 28 days, each participant will receive neoadjuvant study treatment (Pembrolizumab + Chemotherapy OR Placebo + Chemotherapy) based on the randomization schedule for approximately 24 weeks (8 cycles). Each participant will then undergo definitive surgery 3-6 weeks after conclusion of the last cycle of the neoadjuvant study treatment. After definitive surgery, each participant will receive adjuvant study treatment (Pembrolizumab OR Placebo) for approximately 27 weeks (9 cycles). Following adjuvant study treatment, each participant will be monitored for safety, survival and disease recurrence. The primary study hypothesis is that pembrolizumab is superior to placebo, in combination with chemotherapy, as measured by the rate of Pathological Complete Response (pCR) and/or Event-free Survival (EFS), in participants with locally advanced TNBC.
 Lay Summary
 N/A
 WA Trial Sites

 

St John Of God  - Subiaco (08) 6465 9204

   US National Library of Medicine

 

 

 

 

 

Novartis CLEE011X2107 (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/II study. The Phase Ib portion of the study is a dose escalation to estimate the MTD and/or RP2D for three regimens: two double combinations, LEE011 with letrozole and BYL719 with letrozole, followed by the triple combination of LEE011 + BYL719 with letrozole.

The Phase Ib will be followed by a randomized Phase II study to assess the preliminary anti-tumor activity of the two double combination regimens (LEE011+letrozole and BYL719+letrozole) versus the triple combination (LEE011+BYL719 with letrozole) and to further evaluate their safety in patients with ER+/HER2- locally advanced or metastatic breast cancer.

Approximately 300 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

 

 

Novartis CMCS110Z2201

Registered Title

A Randomized Phase II Study of MCS110 Combined With Carboplatin and Gemcitabine in Advanced Triple Negative Breast Cancer (TNBC).

Purpose

To determine whether MCS110 antibody therapy improves the efficacy of carboplatin and gemcitabine (carbo/gem) in advanced TNBC patients.

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

 

 

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

 

 

PALLAS (ANZ 1603, AFT-05, ABCSG 42, BIG 14-03)

Registered Title

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

This is a prospective, two arm, international, multicenter, randomized, open-label Phase III study evaluating the addition of 2 years of palbociclib to standard adjuvant endocrine therapy for patients with HR+ / HER2- early breast cancer (EBC). 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

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

Link

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

 

 

[Return to List of Clinical Trials]