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.

 

A5481037 Study

Registered Title

A Study Of Palbociclib In Combination With Letrozole As Treatment Of Post-menopausal Women With Hormone Receptor-positive, Her2-negative Advanced Breast Cancer For Whom Letrozole Therapy Is Deemed Appropriate.

Purpose

A study of palbociclib in combination with letrozole as treatment of post-menopausal women with hormone receptor-positive, her2-negative advanced breast cancer for whom letrozole therapy is deemed appropriate.

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

 

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

 

COLET Study

Registered Title

A Multistage, Phase II Study Evaluating The Safety And Efficacy Of Cobimetinib In Combination With Paclitaxel As First-Line Treatment For Patients With Metastatic Triple-Negative Breast Cancer.

Purpose

This multistage, randomized, Phase II, double-blind, multicenter, placebo-controlled trial will evaluate the safety and tolerability and estimate the efficacy of cobimetinib + paclitaxel versus placebo + paclitaxel in patients with metastatic or locally advanced, triple-negative adenocarcinoma of the breast that have not received prior systemic therapy for metastatic breast cancer (MBC). An open-label safety run-in stage of the combination cobimetinib + paclitaxel will undergo an Internal Safety Review before starting the enrollment of patients into the expansion double-blind stage of this study. Patients may continue on study treatment until the development of progressive disease, unacceptable toxicity, and/or consent withdrawal. The target sample size is 12 patients for the safety run-in stage and approximately 100 patients in the expansion stage.

Lay Summary

N/A

WA Trial Sites

St John of God Murdoch Logo

Tamsyn Whitcher
Murdoch Oncology Clinical Trials Unit
Ph. (08) 9428 8539
oncologytrials.murdoch@sjog.org.au

Links

US National Library of Medicine

Acknowledgements: 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

 

IMpassion (WO29522)

Registered Title

A Phase III, Multicenter, Randomized, Placebo-Controlled Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Patients With Previously Untreated Metastatic Triple-Negative Breast Cancer.

Purpose

This multicenter, randomized, double-blind study will evaluate the efficacy, safety, and pharmacokinetics of atezolizumab (MPDL3280A) administered with nab-paclitaxel compared with placebo in combination with nab-paclitaxel in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC). The safety of single-agent nab-paclitaxel has been determined in previous studies of participants with mBC and the safety data to date suggest that atezolizumab can be safely combined with standard chemotherapy agents.

Lay Summary

N/A

WA Trial Sites

St John of God Healthcare logo

St John of God
Ph. (08) 6465 9204

Links

US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

KATE2 (WO30085)

Registered Title

A Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Atezolizumab-Placebo in Participants With Human Epidermal Growth Factor-2 (HER2) Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab and Taxane Based Therapy (KATE2).

Purpose

This phase II, double-blind, randomized, placebo-controlled multicenter study will investigate the efficacy and safety of trastuzumab emtansine in combination with atezolizumab or atezolizumab-placebo in participants with HER2-positive locally advanced or metastatic breast cancer who have received prior trastuzumab and taxane based therapy, either alone or in combination, and/or who have progressed within 6 months after completing adjuvant therapy.

Lay Summary

N/A

WA Trial Sites

St John of God Healthcare logo

St John of God
Ph. (08) 6465 9204

Links

US National Library of Medicine

Acknowledgements: 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

 

PENELOPE-B Study

Registered Title

Phase III study evaluating palbociclib (PD‐0332991), a Cyclin‐Dependent Kinase (CDK) 4/6 Inhibitor in patients with hormone‐receptor‐positive, HER2‐normal primary breast cancer with high relapse risk after neoadjuvant chemotherapy.

Purpose

The PENELOPEB study is designed to demonstrate that in the background of standard anti-hormonal therapy palbociclib provides superior invasive disease-free survival (iDFS) compared to placebo in pre- and postmenopausal women with HR-positive/HER2-normal early breast cancer at high risk of relapse after showing less than pathological complete response to neoadjuvant taxane- containing chemotherapy. Considering the high risk of recurrence in patients after neoadjuvant chemotherapy and a high CPS-EG score, palbociclib appears to be an attractive option with a favourable safety profile for these patients.

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

 

POSITIVE (IBCSG 48-14 / BIG 8-13)

Registered Title

A Study Evaluating the Pregnancy Outcomes and Safety of Interrupting Endocrine Therapy for Young Women With Endocrine Responsive Breast Cancer Who Desire Pregnancy.

Purpose

The best available evidence suggests that pregnancy after breast cancer does not increase a woman's risk of developing a recurrence from her breast cancer. In particular, the most recent data suggest that this is the case also in women with a hormone receptor-positive breast cancer. There is also no indication of increased risk for delivery complications or for the newborn. The aim of the study is to investigate if temporary interruption of endocrine therapy, with the goal to permit pregnancy, is associated with a higher risk of breast cancer recurrence.The study aims also to evaluate different specific indicators related to fertility, pregnancy and breast cancer biology in young women. A psycho-oncological companion study on fertility concerns, psychological well-being and decisional conflicts will be conducted in interested Centers.

Lay Summary

N/A

WA Trial Sites

St John of God Healthcare logo

St John of God
Ph. (08) 6465 9204

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

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

 

ROLLIS Randomised Controlled Trial

Registered Title

Can Radio-guided Occult Lesion Localisation using Iodine-125 Seeds (ROLLIS) for excision of impalpable breast cancer reduce the rate of pathologically inadequate margins and /or subsequent oncological surgery compared with standard hook-wire localisation? A randomised controlled clinical trial.

Purpose

This study is comparing the use of low dose radioactive seeds to standard treatment for surgical removal guidance in breast cancer patients.

Lay Summary

Who is it for?

You may be eligible to join this study, if you are a female aged 18 years or above and have been diagnosed with breast cancer that is non-palpable (i.e. the surgeon cannot feel it), and thus require a procedure known as localisation.

Trial details:

When an abnormal area in the breast needs to be removed after a needle biopsy (and the surgeon cannot feel it), the abnormal area is localised. We are comparing two different localisation techniques in this study. Participants will be randomly (by chance) assigned to one of two techniques. Participants in one group will undergo a procedure known as ROLLILS (radioguided occult lesion localisation and removal of impalpable breast cancers). This involves inserting a low-dose sterilised radioactive iodine seed into the patient's cancer under local anaesthesia with imaging guiding.

The patient will then undergo breast conserving surgery within 4 days, during which the surgeon uses the seed to guide removal of the impalpable cancer. Participants in the other group will undergo the standard treatment, known as hook-wire guided localisation (HWL). This is when a hook-wire is placed in the breast on the day of breast conserving surgery by a radiologist. Participants are followed for up to 5 years post-surgery in order to evaluate clinical and cosmetic outcomes, disease recurrence and patient satisfaction. A cost benefit analysis will also be undertaken.

WA Trial Sites

Sir Charles Gairdner Hospital logo   

 Royal Perth Hospital Logo

This trial is open at Sir Charles Gairdiner Hospital and Royal Perth Hospital.

Dr Shashi Aggarwal

ROLLIS Research Coordinator
Ph: +61 8 9224 3649 (RPH)
Ph: +61 8 9346 1834 (SCGH)
shashi.aggarwal@health.wa.gov.au

Links

Australian New Zealand Clinical Trials Registry

Acknowledgements: Australia New Zealand Clinical Trials Registry

 

SANDPIPER Study

Registered Title

A Phase III, Double-Blind, Placebo Controlled, Randomized Study Of Taselisib Plus Fulvestrant Versus Placebo Plus Fulvestrant In Postmenopausal Women With Estrogen Receptor-Positive And Her2-Negative Locally Advanced Or Metastatic Breast Cancer Who Have Disease Recurrence Or Progression During Or After Aromatase Inhibitor Therapy.

Purpose

This international, multicenter, randomized, double-blinded, placebo-controlled study is designed to compare the efficacy and safety of taselisib + fulvestrant with that of placebo + fulvestrant in postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative, PIK3CA-mutant, unresectable, locally advanced or metastatic breast cancer after recurrence or progression during or after an aromatase inhibitor (AI) therapy. There will be a 2:1 randomization to the taselisib arm versus the placebo arm. Enrollment will be enriched for patients with PIK3CA mutant tumors via central testing. The anticipated duration of the study is approximately 3.5 years.

Lay Summary

N/A

WA Trial Sites

St John of God Murdoch Logo

Tamsyn Whitcher
Murdoch Oncology Clinical Trials Unit
Ph. (08) 9428 8539
oncologytrials.murdoch@sjog.org.au

Links

US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

 

[Return to List of Clinical Trials]