Abstract OT3-11-01: Adaption of the EORTC QLQ-breast cancer module for male BC: Phase I
Authors: Bjelic-Radisic Vesna , Cardoso Fatima , Bottomley Andrew 
Published: March 2020

Abstract
Background: One percent of all new cases of breast cancer (BC) diagnosed annually is male BC. Although, the incidence increased by about 26% over the past 25 years, basic and clinical research focusing on male BC is limited. Care of male breast cancer is largely based on extrapolation from treatment strategies and management of symptoms in women. The impact of the breast cancer diagnosis and therapy on QoL in women with breast cancer is well documented. Comprehensive, prospective data about QoL in men treated for BC are lacking.
Trial design:
The evaluation of the QoL issues relevant for male BC, as well as the translation of issues into items to build the tool for QoL assessment in male BC will be carried through four phases:
1. Literature review
2. Interviews with patients
3. Interviews with health care professionals(HCP)
4. Consultation of experts in Oncology and QoL:
Statistical methods:
A total of 2-5 patients/year recruited from collaborating hospitals/countries (at least 100 overall) will be interviewed before, during or after treatment. Purposive sampling will aim to achieve good representation according the treatment. At least at 2 experts/unit from the all collaborating centres will be include in the interview to discuss and consider the potential issues.
Inclusion criteria:Histologically proven EBC or LABC male BC patients who before, during or after treatment.Age ≥ 18 years.Ability to understand and fill out questionnaires.Written informed consent.
Exclusion criteria:Other cancer in the past 5 years except non-melanotic skin cancer or CINPatients participating in interventional clinical studies with QoL as primary endpoint.Any condition potentially hampering compliance with the study protocol
Other cancer in the past 5 years except non-melanotic skin cancer or CIN
Patients participating in interventional clinical studies with QoL as primary endpoint.
Any condition potentially hampering compliance with the study protocol
Aims:
The study proposes to carry out an evaluation of the QoL issues relevant for male BC, and translating the issues in the items to build the tool for QoL assessment in male BC. The specific aims are:
1) To carry out an evaluation of the EORTC QLQ-BR 45 (adapting for male BC) and for suitability of use in male BC patients
2) To carry out an evaluation of the EORTC QLQ-PR25 (adapting for male BC) for suitability of use in male BC patients
3) To provide recommendations to the EC on a suitable assessment approach to assess HRQOL in male BC
Statistical methods:
A total of 2-5 patients/year recruited from collaborating hospitals/countries (at least 100 overall) will be interviewed before, during or after treatment. Purposive sampling will aim to achieve good representation according the treatment. At least at 2 experts/unit from the all collaborating centres will be include in the interview to discuss and consider the potential issues.
Study start: Q2/2019
Contact:
Vesna Bjelic-RadisicE-Mail: Vesna.Bjelic-Radisic@helios-gesundheit.de
Citation Format: Vesna Bjelic-Radisic, Fatima Cardoso, Andrew Bottomley. Adaption of the EORTC QLQ-breast cancer module for male BC: Phase I [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 OT3-11-01.