Optimising Adjuvant Chemotherapy Prescription in Young Patients With Hormone-dependent Breast Cancer Using Genomic Tests

Invasive Breast Cancer Free Survival (IBCFS) in the population with tumours for which the Prosigna® score is below the cut-off (≤60) for chemotherapy use, defined according to the STEEP version 2.0 system (Tolaney et al., JCO 2021) as the time from the date of randomization to the date of the first event of ipsilateral loco-regional invasive breast cancer recurrence, distant breast cancer recurrence, contralateral new invasive primary breast cancer or death from any cause.

time from the date of randomization to the date of the first event of distant recurrence of breast cancer or death from breast cancer in the global population

time from the date of randomization to the date of the first event of distant recurrence of breast cancer or death from any cause in the global population

time from the date of randomization to the date of death from breast cancer in the global population

in the global population, time from the date of randomization to the date of death from any cause in the global population

in the population with tumours for which the Prosigna® score is ≤60 time from the date of randomization to the date of the first event of distant recurrence of breast cancer or death from breast cancer

in the population with tumours for which the Prosigna® score is ≤60 time from the date of randomization to the date of the first event of distant recurrence of breast cancer or death from any cause

time from the date of randomization to the date of death from breast cancer in the population with tumours for which the Prosigna® score is ≤60

time from the date of randomization to the date of death from any cause in the population with tumours for which the Prosigna® score is ≤60

number of non-traumatic fractures

major cardioscular events including stroke, myocardial infarction, heart failure and cardiovascular deaths

Questions regarding the number of pregnancies, number of living children, any complications during pregnancy or affecting the fetus, as well as the use of contraceptives.

Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials. The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

this EORTC breast cancer specific questionnaire is intended to supplement the QLQ-C30.

The QLQ-BR42 incorporates nine multi-item scales to assess body image, sexual functioning, breast satisfaction, systemic therapy side effects, arm symptoms, breast symptoms, endocrine therapy symptoms, skin mucosis symptoms, endocrine sexual symptoms. In addition, single items assess sexual enjoyment, future perspective and being upset by hair loss. All items are rated on a four-point Likert-type scale (1 = "not at all", 2 = "a little", 3 = "quite a bit", and 4 = "very much"), and are linearly transformed to a 0-100 scale. Higher scores indicate more severe symptoms or problems for all items.

The EQ-5D-5L (EuroQol 5-Dimension 5-Level) questionnaire is a standardized tool used to assess a person's overall health status. It covers five key dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels of severity, ranging from 1 (no problems) to 5 (extreme problems). A patient's health state is summarized by combining their responses into a five-digit code, with each digit representing the level of difficulty in one dimension.

The Generalized Anxiety Disorder scale (GAD-7) is a 7-item screening tool used to identify and assess the severity of anxiety disorders. Each item is rated on a 4-point scale: 0 (never), 1 (several days), 2 (more than half the days), and 3 (nearly every day). The total score ranges from 0 to 21, with higher scores indicating greater anxiety. Based on the total score, individuals are classified into one of four categories: minimal anxiety (0-4), mild anxiety (5-9), moderate anxiety (10-14) or severe anxiety (15-21).

The Patient Health Questionnaire-8 (PHQ-8) is an eight-item tool used to screen for and assess the severity of depressive disorders. It focuses on depressive symptoms experienced over the past two weeks. Each item is scored on a scale from 0 (not at all) to 4 (nearly every day), resulting in a total score ranging from 0 to 32. A score of 10 or higher suggests the presence of major depression, while a score of 20 or above indicates severe major depression.

The FACT-Cog is a self-assessment questionnaire to estimate memory, attention, concentration, language, and thinking abilities of patients before, during, and after chemotherapy. This questionnaire, composed of 37 items consists of four subscales: cognitive impairments perceived by the patient (20 items), comments from others (4 items), cognitive abilities perceived by the patient (9 items), and impact on quality of life (4 items). The Perceived Cognitive Impairments and the Comments from Others subscales are rated on 5-point Likerttype scale (from 0 = "Never" to 4 = "Several times a day"). An intensity 5-point Likert-type scale (from 0 "Not at all" to 4 "Very much") is used to rate perceived cognitive abilities and the impact on quality of life. For all subscales, a higher score represents better cognitive functioning or quality of life.

The distress thermometer is an informational tool designed to be shared during appointments to help patients identify their main concerns or side effects and build a personalized action plan. This tool follows a five-step process: patients first rank 3 to 5 top concerns using the NCCN® Distress Thermometer, which contains a simple and reliable 0-to-10 scale for screening distress. In addition, this tool includes a problem list to help users pinpoint sources of distress. It helps patients to reflect on their problems and has proven effective in guiding appropriate psychosocial support and referrals

Questionnaire assessing the support and opportunities available for returning to work after treatment. It also evaluates how treatment and medical appointments impacted work responsibilities during the diagnostic and treatment period, including any changes in remuneration during this time.

Short question regarding menstrual regularities and pregnancy status.

A questionnaire regarding the fear of cancer recurrence in the last month. Consisted by 9 items and has been used as a tool to screen for clinical levels of FCR. Each item is rated on a scale from 0 (not at all or never) to 4 (a great deal or several). Higher scores indicate greater FCR severity, with a maximum score of 36.

An evaluation designed by The Royal Marsden NHS Foundation Trust to understand patients' experiences in clinical trials and the factors influencing their decision to participate. The questionnaire includes several questions aimed at exploring patients' opinions after enrolling in the trial, as well as the key reasons that motivated their participation.

Ad hoc questionnaire. Questions about the listed side effects that patients may experience during treatment, as mentioned by the healthcare professional during their medical consultation

The 4-item SURE screening test is used to evaluate the probability of a patient having decisional conflict. It is composed of four questions (Sure of myself; Understand information; Risk-benefit ratio; Encouragement) and the patient may answer YES or NO. In case of answering at least one "NO", it indicates the probability that a patient experiences clinically significant decisional conflict.

This scale measures the distress or remorse after a decision regarding health care. Through 5 different items, in which patients can 1-strongly agree up to 5-strongly disagree a 0-100 scale is formed to evaluate the patient satisfaction of the decision taken.

A questionnaire regarding the physical activities in the last 7 days. In the short form of the IPAQ questionnaire 7 questions are made regarding the intensity of physical activity. The results are converted into METs, a method to quantify energy spent in physical activities. Based on this, 3 different levels are proposed: low, moderate or high.

Body Mass Index (BMI) is a widely used measure to assess whether an individual's weight is appropriate for their height. It is calculated using the formula: BMI = weight (kg) / height (m²). Based on the resulting value, BMI is categorized as follows: Underweight: BMI < 18.5; Normal weight: BMI 18.5 - 24.9; Overweight: BMI 25.0 - 29.9; Obesity: BMI ≥ 30.0

Assessment includes the frequency of alcohol consumption in the last 12 months and smoking status of the patient, including the quantity consumed in both cases.

The self-reported adherence questionnaire aims to assess how often patients forget to take their hormone therapy and to identify the reasons behind missed doses.

Questionnaire that aims to list different aspects of healthcare services usage in the previous 3 months: inpatient stay, outpatient consultation, number and type of exams done. There are also questions regarding the amount spent for travels to attend hospital or other health and social care appointments, including any unplanned visits.

The System Usability Scale (SUS) is a standardized survey designed to evaluate the perceived usability of a system or product. It generates a score ranging from 0 to 100, with higher scores indicating better usability. The SUS consists of 10 statements, each rated on a 5-point Likert scale, where 1 means "strongly disagree" and 5 means "strongly agree." Respondents' answers reflect their overall satisfaction and ease of use of the system.

time from the date of randomization to the date of the first event of distant recurrence of breast cancer or death from breast cancer in the global population