Clinical Trials

At BCRC-WA, our dedicated Breast Clinical Trials Unit (BCTU) performs many clinical trials including those designed to:

• evaluate new treatments versus current (approved) treatments,
• evaluate approved treatments in new settings,
• evaluate ways of reducing side effects of treatment
• expand the understanding of the biological behavior of breast cancer
• investigate the social and emotional impact of breast cancer on patients and their families.

These studies may be in conjunction with pharmaceutical companies, universities and other collaborative healthcare groups as well as “in-house” studies termed “Investigator Initiated Research (IIR)”.

By designing and funding our own studies, we can focus directly on the needs of our own patients seen through the Perth Breast Cancer Institute. For example, the BCOS study (Breast Cancer Offspring Study) was designed by Prof Chan to investigate the needs of children whose mother had been given a diagnosis of breast cancer after she saw many of her patients were concerned about the effects of their breast cancer experience on their children. Read more about our Investigator Initiated Research here.

Considering the stage (early or advanced) of the cancer and testing for tumour cell characteristics allows doctors to “tailor” cancer treatment to better suit each patient.

Many people think that clinical trials all involve a placebo and that patients may not be receiving any active treatment at all. In fact, very few of our clinical trials use placebo and those that do use the placebo to compare it with a new drug given in addition to an approved or current treatment. In this way, all patients receive the current best care for them as a minimum.

Below is a glossary of terms which may help you understand some of the terms used in clinical trial titles.

Adjuvant	“in addition to”. This term is used to describe treatments given to add to the effectiveness of other treatments. Usually used in the Early Breast Cancer setting to describe intravenous drug therapy, oral endocrine treatment, or radiotherapy given after surgery.
Advanced	See Metastatic
Double-blind	Neither the patient nor the trial staff (including doctor) know whether the patient is receiving the investigational product.
Endocrine therapy (aka Hormonal therapy)	Treatment used to block the effects of certain hormones in the body. See ER/PR below
ER/PR positive/negative (aka Hormone Receptor positive/negative)	ER refers to Oestrogen receptor, while PR refers to Progesterone receptor. Oestrogen and Progesterone are naturally occurring hormones. Receptors for these hormones may be present on breast cancer cells. These cells would then be called ER or PR positive.
HER2	HER2 is a protein on the outside of some breast cancer cells. It promotes cell growth. Breast cancer cells with higher than normal levels of Her2 are called HER2-positive, those with lower levels are called HER2-negative.
Induction treatment	First line or initial therapy given for breast cancer
IV	Intravenous. A therapy given directly into a vein
Locally Advanced	Breast cancer which has not spread to distant parts of the body but is of a large size or has spread to several lymph nodes in the axilla (armpit)
Metastatic	Cancer which has spread to other parts of the body outside of the breast and axilla (armpit)
Monotherapy	Treatment with a single medication rather than a combination
Neoadjuvant	Treatment given in the early breast cancer setting before surgery
Open Label	The patient and the clinical trial staff, including the doctor, know which treatment the patient will receive
Oral	Taken by mouth
Phase 1	A study to determine best dose and identify side effects of a new drug. Usually given in a small group of participants who have already received several drug therapies for their cancer. Very close monitoring of participants.
Phase 2	Once safety has been evaluated in Phase 1, a Phase 2 study involves evaluation of efficacy (whether the drug works as intended) in a larger group of participants (several hundred). Safety and side effects are still closely monitored.
Phase 3	A study to compare how effective a new treatment is compared with current best treatments, or other similar new treatments, in a much larger group of participants (often several thousand). Safety and side effects still closely monitored.
Pre-operative	Treatment given for breast cancer setting before surgery
Prophylaxis	Preventative
Randomised	Assigned to a treatment in a random way, like tossing a coin. In clinical trials, this is usually done through a de-identified and centralized database
SOC – Standard of Care	The best treatment currently available in this setting
SC (subcutaneous)	Sometimes also written as “subcut”. An injection given into the tissue layer between the skin and the muscle. Usually the abdomen, upper arm or thigh.
TPC – Treatment of Physician’s Choice	Treatment decided by the treating oncologist and is regarded as an appropriate and effective option for an individual patient at that timepoint in their breast cancer treatment journey
Triple Negative	HER2 negative and negative for both hormone receptors (ER and PR)

BCTU are currently involved in clinical trials for early, locally advanced and advanced/metastatic breast cancer. In addition, there are several IIR trials in progress to evaluate the biological behaviour of breast cancer and the patient-centred consequences of breast cancer.

For a full list of current clinical trials click here.