The Prosigna Breast Cancer Prognostic Gene Signature Assay is a genomic test that analyses the activity of certain genes is early-stage, HR-positive breast cancer. The Assay may be used to make treatment decisions based on the risk of recurrence for postmenopausal women within 10 years of diagnosis after 5 years of hormonal treatment.
PARP (poly (ADP-ribose) polymerase) Inhibitors
A class of targeted therapy drugs (e.g. olaparib) that block an enzyme involved in DNA repair.
PARTICIPANT INFORMATION SHEET
A document that provides clinical trial participants with important information relating to a specific trial. The purpose is to the assist the participant in the decision-making process regarding their potential participation in the trial.
Any public or private hospital or facility where clinical trials are conducted.
PHASE II CLINICAL TRIAL
The second stage of the evaluation of a new drug in humans; these trials evaluate drug safety and preliminary effectiveness in a large number of participants.
PHASE III CLINICAL TRIAL
Study the effectiveness of an intervention (e.g. study drug) in large groups of trial participants by comparing the intervention to other standard or experimental interventions (or to non-interventional standard care). Phase III studies are also used to monitor adverse effects and to collect information that will allow the intervention to be used safely.
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, in combination with standard treatment, to assess the new 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”.
Aims to find better ways to prevent breast cancer in healthy women.
PRINCIPAL INVESTIGATOR (PI)
The person responsible for overseeing all aspects of a specific clinical trial at a BCT participating institution. Duties include recruiting participants, obtaining informed consent from participants, ensuring the trial protocol is adhered to, maintaining oversight of GCP at the site.
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.
Surgery to remove one or both breasts 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.