Abstract OT3-16-01: Follow-up in early (EBC) and locally advanced (LABC) breast cancer patients; EORTC protocol 1617-QLG-BCG-ROG
Authors: Bjelic-Radisic Vesna , Cardoso Fatima , Velikova Galina , Cameron David , Westenberg Helene , Pogoda Katarzyna , Beauvois Melanie , Verbiest Tim , Coens Corneel , Bottomley Andrew 
Published: March 2020

Abstract
Background: Although the incidence of breast cancer (BC) has increased in the last twenty years, the prognosis and outcomes of those patients have changed dramatically, with survival rates increasing with at least 75% of women surviving or more for then years. Published data showed that BC treatment can lead to long-term physical impairments and functional limitation. Evidence-based follow-up strategies regarding risk, patients’ needs and quality of life (QoL) are still lacking.
Trial design: A cross-sectional follow-up study of EBC and LABC patients after primary treatment will be conducted Patients will be invited to complete on a single occasion a set of patient reported questionnaires (PROMs) when attending the hospital for follow-up. Clinical and demographic data regarding the patient disease, treatment and follow-up will be collected.
Inclusion criteria:Histologically proven EBC or LABC patients who have completed their primary treatment (except endocrine therapy), 12 - 36 months after the diagnosis,Disease-free without any evidence of relapseAge ≥ 18 years.Ability to understand and complete questionnaires.Written informed consent.
Exclusion criteria:Evidence of metastatic breast cancerOther cancer in the past 5 years except non-melanotic skin cancer or CINMale breast cancer.Patients on maintenance therapy (other than endocrine therapy).Patients participating in interventional clinical studies with QoL as primary endpoint.Any condition potentially hampering compliance with the study protocol and follow-up schedule.
Aims: to assess the physical, sexual and emotional needs of EBC and LABC patients across Europe following treatment with curative intent.to describe current follow-up patterns of EBC and LABC in different countries (length and frequency of follow-up, who does it: oncologists, surgeon, nurses, GPs, which type of exams).to identify patients at high-risk of emotional or physical problems in comparison to self-reported physical and emotional status with the general population.comparison of different follow-up models regarding patients outcomesinvestigate correlations between physical, sexual and emotional needs with factors specific to the patient, specific to disease and its treatment.
Statistical methods:
In order to detect clinical relevant differences of 10 points on a 100-point QLQ-C30 scale, a total of 120 patients is needed in each subgroup of interest.
Sample size is then driven by number of treatment options. Six distinct options were identified based on combinations of surgery, radiotherapy, endocrine therapy, chemotherapy and targeted therapy; yielding a total sample size of 6 * 120 = 720 patients. A further 15% buffer to the sample size due to potential missing data, gives a total sample of approximately 830 patients from 36 centres.
Descriptive statistics for socio-demographic and clinical data, overall and per treatment, age and risk group will be reported. Patterns of follow-up will be identified and described overall, and per treatment, age, risk group and country. Normative data will be used to identify those QoL domains where there is a clinically relevant differencefrom the general population. Multivariable model building will be used to build predictive models on the overall population to investigate determinants for the physical, sexual and emotional needs based on the identified PROM outcomes. Factor analysis will be undertaken to investigate the inter-correlations between physical, sexual and emotional needs in the overall population and in the relevant subgroups of interest.
Recruitment start: Q2/2019
Contact:
Mélanie Beauvois
E-Mail: melanie.beauvois@eortc.be
Vesna Bjelic-RadisicE-Mail: Vesna.Bjelic-Radisic@helios-gesundheit.de
Citation Format: Vesna Bjelic-Radisic, Fatima Cardoso, Galina Velikova, David Cameron, Helene Westenberg, Katarzyna Pogoda, Melanie Beauvois, Tim Verbiest, Corneel Coens, Andrew Bottomley. Follow-up in early (EBC) and locally advanced (LABC) breast cancer patients; EORTC protocol 1617-QLG-BCG-ROG [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr OT3-16-01.