Breast Cancer

Clinical trials for women and men with breast cancer. This includes lobules, ducts and surrounding breast tissue.

If you would like to be considered for a clinical trial you will require a referral from your current treating team. Visit the Joining a Clinical Trial page for referral information. 

For more information on clinical trials, get in contact with our cancer clinical trials enquiry coordinator.

Clinical Trials Enquiry Coordinator

Business hours, Mon to Friday between 9am - 2pm
Email Clinical Trials Enquiries
Phone (03) 8559 7456

Open and Recruiting Clinical Trials

A trial to improve outcomes in HER2 positive breast cancer by adding immunotherapy medications for patients that have progressed on standard anti-HER2 therapy

Cancer type

HER2 positive breast cancer

Status

Open and recruiting

Phase

Two: A phase two clinical trial follows a phase one, in a large group of patients with selected cancer types. The aim of a phase two is to find out if the new treatment is effective in these cancer types.

Brief summary

The DIAmOND study is a trial aiming to improve standard treatment for patients with HER2 positive breast cancer. Human Epidermal Growth Factor 2 “HER2” is a receptor on cancer cells which can promote cancer growth. The standard treatment for this kind of breast cancer is a drug called Trastuzumab which targets it specifically.The DIAmOND study is for patients who have already had Trastuzumab but have gotten worse [progressed] since starting it. In this trial the aim is to improve the outcomes by adding 2 additional new medications (tremelimumab and Durvalumab) which work by to helping the immune system to fight cancer.

Who can participate

Patients who: 

  • Have a diagnosis of HER2 positive breast cancer
  • Have already been treated with Trastuzumab but have not responded to it

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

A clinical trial investigating the benefit of adding chemotherapy drug, Palbociclib to improve standard treatment for HER2+ breast cancer treatment

Cancer type

HER2 positive breast cancer

Status

Open and recruiting

Phase

Three: A phase three clinical trial follows a phase two, in a larger group of patients with specific cancer types. The aim of a phase three is to compare the new treatment to what is available for that cancer type.

Brief summary

The PATINA trial is designed to investigate whether or not the addition of chemotherapy drug Palbociclib to standard treatment can be tolerated safely and lead to improved outcomes in people with HER2+ breast cancer.
The standard therapy for patients with this kind of cancer is therapy which specifically targets the HER2 receptor (usually Trastuzumab or Pertuzumab) as well as receiving endocrine therapy to slow down cancer growth driven by hormones (usually Fulvestrant).

Everyone on the trial will get either of the following treatment arms:

  • Study arm: Palbociclib with anti HER2 and endocrine therapy
  • Standard arm: Anti Her 2 therapy and endocrine therapy
Who can participate

Patients who:

  • Have HER2 positive breast cancer diagnosis
  • Cancer has spread to other parts of the body

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

A clinical trial investigating the safety and effectiveness of the combination of drugs Tamoxifen and ABT-199 in patients with hormone sensitive breast cancer

Cancer type

Breast Cancer

Status

Open and recruiting

Phase

One: A phase one clinical trial tests new treatments sometimes for the first time in humans, usually in a small group of patients. The aim of a phase one is to test the safety of the new treatment and find the best dose to give patients.

Brief summary

The M-BEP clinical trial is investigating a new combination of two drugs to treat a specific type of breast cancer that is both responsive to the hormone Oestrogen  (ER+) as well as containing a specific protein marker called BCL-2. The existing drug Tamoxifen and the new study drug called ABT-199 are designed to treat cancer by targeting ER and BCL-2 respectively. It is thought that combining them will lead to better outcomes in patients with this specific type of cancer

All patients on the trial will receive both drugs in combination and there are no placebo or control groups.

Who can participate

Patient who:

  • Have not recently been treated with tamoxifen
  • Cancer sensitive to estrogen and contains BCL-2 protein (ER+, BCL-2+)
  • Cancer spread to other parts of the body

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

A clinical trial investigating the effectiveness and safety of treating ER+ and BCL2+ cancer with Palbociclib, Letrozole and Venetoclax given together

Cancer type

Breast cancer

Status

Open and recruiting

Phase

One: A phase one clinical trial tests new treatments sometimes for the first time in humans, usually in a small group of patients. The aim of a phase one is to test the safety of the new treatment and find the best dose to give patients.

Brief summary

In this clinical trial, three cancer drugs Palbociclib, Letrozole and Venetoclax are given together to find what dose works best when all three are being used. It is not currently known which combination of dose is the safest and most effective to treat this kind of cancer. Throughout the study the dose of medication will be slowly increased as more participants enter the trial. Because of this design the actual dose of the medications you receive will depend on whether that dose has already been shown to be safe.

Who can participate

Patients who: 

  • Cancer sensitive to estrogen and contains BCL-2 protein (ER+, BCL-2+)
  • Cancer spread to other parts of the body

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

A clinical trial to determine if it is more effective to give Hormone therapy (Fulvestrant) alone or given together with Chemotherapy for metastatic breast cancer

Cancer type

Breast cancer

Status

Open and recruiting

Phase

Two: A phase two clinical trial follows a phase one, in a large group of patients with selected cancer types. The aim of a phase two is to find out if the new treatment is effective in these cancer types.

Brief summary

In this clinical trial participants will receive either of the following regimes:

  • Hormone therapy, Fulvestrant alone
  • Hormone therapy, Fulvestrant in combination with oral Chemotherapy, Venetoclax

For patients with this kind of cancer, Hormone therapy is the standard care. By comparing these two groups the trial is aiming to determine if one group is better than the other in terms of safety and effectiveness.  

Who can participate

Patient who:

  • Are sensitive to estrogen (ER+) but not the HER2 protein (HER2-)
  • Cancer spread to other parts of the body
  • Was not responsive to the first treatment given since cancer has spread
  • Cancer has come back (recurred) since being treated the first time

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

A clinical trial to test the safety and effectiveness of GDC-9545 for breast cancer patient requiring surgery

Cancer type

Breast cancer

Status

Open and recruiting

Phase

One: A phase one clinical trial tests new treatments sometimes for the first time in humans, usually in a small group of patients. The aim of a phase one is to test the safety of the new treatment and find the best dose to give patients.

Brief summary

In this clinical trial, different doses of the new medication GDC-9545 will be given to patients who are requiring to undergo surgery to remove their breast cancer. Normally treatment is not given between diagnosis and surgery but this trial is aiming to find out which is safest and most effective dose in order to improve outcomes after surgery.

All patients will receive GDC in one of 4 different strengths prior to surgery and will be followed up afterwards.

Who can participate

Women who:

  • Are recommended for surgical removal of their breast cancer
  • Have breast cancer that is sensitive to hormone Oestrogen (Oestrogen Receptor +)
  • Have already gone through menopause

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

A clinical trial to test the safety and effectiveness of Ribociclib to improve standard treatment for hormone receptor positive breast cancer

Cancer type

Breast cancer

Status

Open and recruiting

Phase

Three: A phase three clinical trial follows a phase two, in a larger group of patients with specific cancer types. The aim of a phase three is to compare the new treatment to what is available for that cancer type.

Brief summary

NATALEE clinical trial is for patients who have breast cancer that is primarily driven by hormonal signalling [AKA Hormone Receptor “HR” positive]. The standard treatment for patients with this type of cancer is endocrine therapy (usually a drug called Letrozole) which blocks oestrogen that drives the cancer growth.

In addition to this, NATALEE trial is aiming to test if Ribociclib can improve outcomes for this kind of cancer. Ribociclib is a medication that helps to stop cancer growth by attacking the cancer cells directly.

Patients on the trial will receive one of the following:

  • Standard treatment: endocrine therapy alone (Usually Letrozole)
  • Study treatment: Endocrine therapy plus Ribociclib
Who can participate

Patients with recent diagnosis of breast cancer who: 

  • Display the hormone receptor (HR positive)
  • Does not display the HER2 receptor (HER2 negative)
  • Have had cancer removal surgically

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

A clinical trial investigating different combinations of immunotherapy medications to treat Triple Negative Breast Cancer

Cancer type

Triple negative breast cancer

Status

Open and recruiting

Phase

One/two: A phase one / two clinical trial combines a phase one and two. The phase one tests new treatments sometimes for the first time in humans, usually in a small group of patients. The phase two part tests the new treatment in a larger group of patients with selected cancer types. The aim of a phase one / two test for the new treatment to find the best dose and find effective in these cancer types

Brief summary

Triple negative breast cancer makes up a small percentage of breast cancer – it does not display any of the usual three protein groups on the cell surface (HER2 receptor, Estrogen Receptor and Progesterone Receptor) and can therefore be difficult to treat.

This trial will test the safety and effectiveness of multiple different treatment combinations for a class of treatments which work by assisting the body’s own immune system to attack cancer cells.

Who can participate

Patients who have cancer that:

  • Has spread to other parts of the body
  • Does not display HER2, ER, or PR proteins on the cancer surface
  • Did not respond or got worse after trying chemotherapy

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

A clinical trial to compare standard treatment of HER2 positive breast cancer to DS-8201a; an anti-HER2 medication

Cancer type

HER2 positive breast cancer

Status

Open and recruiting

Phase

Three: A phase three clinical trial follows a phase two, in a larger group of patients with specific cancer types. The aim of a phase three is to compare the new treatment to what is available for that cancer type.

Brief summary

DESTINY is a clinical trial that is designed to compare a new drug called DS-8201a to the standard treatment for HER2 positive breast cancer. HER2+ breast cancer is a subtype of breast cancer which displays the HER2 protein on the surface. There are already a few medications which can be used to treat this type of cancer.

DS-8201a is a new medication which is designed specifically to target the HER2 protein in order to target and kill cancer cells while avoiding healthy cells.

Everyone on this trial will receive one of two study arms

  • Standard arm: one of the standard treatments to treat HER2+ cancer
    • either trastuzumab/capecitabine or Lapatinib/capecitabine
  • Study arm: DS-8201a (the study drug)
Who can participate

Patients who have cancer that:

  • Has gotten worse after already being on a different treatment
  • Has spread to other parts of the body (metastasized) or is not surgically removable.
  • Is HER2 positive (displays the HER2 protein on the cancer surface)

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

A clinical trial to test the safety and effectiveness of GDC9545 for patients with ER+ breast cancer

Cancer type

ER+ breast cancer

Status

Open and recruiting

Phase

One: A phase one clinical trial tests new treatments sometimes for the first time in humans, usually in a small group of patients. The aim of a phase one is to test the safety of the new treatment and find the best dose to give patients.

Brief summary

The SERD clinical trial will look at the safety and effectiveness of a new drug called “GDC-9545” to treat a specific type of breast cancer that is sensitive to the Oestrogen hormone and has already spread to other parts of the body.

It is not currently known which dose of this medication is both most safe and most effective or if it is better to give in combination with another drug called Palbociclib.
This study aims to improve this by giving a slightly higher dose each time after a lower dose is found to be safe – therefore the exact strength and combination of drugs will depend on when you enter the study.

Who can participate

Patients who:

  • Have ER+ breast cancer
  • Have breast cancer negative for growth factor HER2

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial. 

A clinical trial to test the safety and effectiveness of Stereotactic radiation with immunotherapy in patients with advanced triple negative breast cancer

Cancer type

Breast cancer

Status

Open and recruiting

Phase

Two: A phase two clinical trial follows a phase one, in a large group of patients with selected cancer types. The aim of a phase two is to find out if the new treatment is effective in these cancer types.

Brief summary

AZTEC study is different methods of applying a treatment called radiotherapy to a subtype of breast cancer called Triple Negative breast cancer (which contains none of the 3 usual surface proteins; HER2, Estrogen receptor and Progesterone Receptor proteins).

The most optimal schedule and strength of radiating the cancer is not known for this type of cancer.

Patients will have their cancer treated with either

  • One single high dose of radiation (20Gy)
  • Three smaller doses of radiation (to a total of 24 Gy)

All patients then go on to receive a medication called Atezolizumab which is standard medication for this kind of cancer.

Who can participate

Patients who:

  • Have Triple Negative (contains none of the three main receptor proteins; HER2, ER, PR) breast cancer
  • Have breast cancer that has spread to other parts of the body

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial. 

A clinical trial of Nivolumab, Chemotherapy and Adjuvant Endocrine Therapy in Patients With (ER+), and (HER2-) Primary Breast Cancer

Cancer type

Breast cancer

Status

Open and recruiting

Phase

Three: A phase three clinical trial follows a phase two, in a larger group of patients with specific cancer types. The aim of a phase three is to compare the new treatment to what is available for that cancer type.

Brief summary

The trial is aiming to assess a patients overall outcome, safety and changes in physical function for patients with high risk primary breast cancer. Treatment will be given before and after surgery.

Who can participate

Patients who have breast cancer that:

  • Is newly diagnosed breast cancer
  • Have never received treatment before
  • Are High risk

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

A clinical trial of Hormonal Therapy plus Palbociclib versus Hormonal Therapy plus Placebo in Women with Operable, Hormone Sensitive and HER2-Negative Primary Breast Cancer

Cancer type

Breast cancer

Status

Open and recruiting

Phase

Three: A phase three clinical trial follows a phase two, in a larger group of patients with specific cancer types. The aim of a phase three is to compare the new treatment to what is available for that cancer type.

Brief summary

This clinical trial to test the safety and effectiveness of hormonal therapy plus Palbociclib is better than hormonal therapy plus placebo before surgery. Palbociclib is a targeted therapy that blocks the growth of cancer cells. Whereas hormonal therapy (also called endocrine therapy) aims to stop or slow the growth of cancer cells. Providing these treatments together aims to provide patients with better treatment outcomes.

Who can participate

Patients who have:

  • Breast cancer
  • Breast cancer that is negative for the HER-2 receptor

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.