An alleviating treatment that can give relief from symptoms, but is not a cure for the disease.
PARTICIPANT INFORMATION SHEET
A document designed to provide participants with relevant information and facts relating to the proposed clinical trial in order for the participant to make an informed decision regarding their participation in the trial.
Any public or private hospital or facility where ANZBCTG clinical trials are conducted.
Physician who identifies diseases by studying tissues or cells under a microscope.
PHASE I CLINCIAL TRIAL
A phase I clinical trial is conducted to test a new biomedical intervention for the first time in a small group of people, to evaluate the safety and side effects of the new treatment or intervention.
PHASE II CLINICAL TRIAL
The second stage of the evaluation of a new drug in humans; these trials evaluate drug safety and preliminary efficacy (effectiveness) in a large number of participants (up to several hundred).
PHASE III CLINICAL TRIAL
The most rigorous and extensive type of scientific clinical investigation of a new treatment. These trials are designed to determine the effectiveness of a treatment, often by comparing it to an existing standard therapy or a placebo, in a large number of participants (typically hundreds or thousands). A phase III trial is generally required before a drug would be approved by regulatory authorities for general use.
PHASE IV CLINCIAL TRIAL
Conducted after the new treatment or intervention has been marketed and approved. A phase IV trial aims to learn more about the side effects and safety of the new treatment, the long-term risks and benefits of the new treatment and how effective the treatment is when used in the general population over a longer period of time.
PI3K (Phosphatidylinositol 3’-kinase)
a protein produced by the body that can change the cell-to-cell communications which affect cell growth and survival.
An inert tablet (such as a sugar pill), liquid or powder that has no active ingredient. In clinical trials, experimental treatments are often compared with a placebo to assess the treatment’s effectiveness.
A finding which assists a clinician to assess whether an individual’s cancer will respond either positively or negatively to a particular treatment. For example, the presence of oestrogen receptors predicts for response to hormone treatment. This term is often confused with “prognostic factor”.
A trial aiming to find better ways to prevent breast cancer in healthy women.
PRINCIPAL INVESTIGATOR (PI)
The person responsible for overseeing all aspects of a clinical trial at an ANZBCTG participating institution; recruiting participants; obtaining informed consent; and collecting data.
PROGESTERONE RECEPTOR (PR)
A protein that may be present on certain cells to which progesterone molecules can attach. The term “PR-positive” refers to tumour cells that contain the progesterone-receptor protein. These cells are generally sensitive to hormone therapy.
The combination of a number of aspects of a person’s general condition and disease diagnosis. General factors can include, but are not limited to, age, gender, lifestyle, and medical history. Specific disease related factors can include disease diagnosis, stage, tumour size and location and treatment options. The combination of these factors can result in either a favourable or poor prognosis.
PROGRESSION-FREE SURVIVAL (PFS)
The time from trial randomisation until cancer progression or death from any cause. PFS is considered a surrogate of overall survival, with the advantage that it can be measured in smaller clinical trials with shorter follow-up. Therefore, it can be used to bring new therapies into clinical practice in a shorter timeframe.
PROPHYLACTIC MASTECOMY (PREVENTATIVE MASTECOMY)
The surgical remove of one or both breast to reduce the risk of developing breast cancer.
A written, detailed action plan for a clinical trial. The protocol provides the background, specifies the objectives, and describes the design and organisation of the trial.