Abstract OT1-16-01: Trial In Progress: An Evaluation of FACIT-Fatigue in Patients with Locally Advanced or Metastatic Breast Cancer receiving Treatment with Taxane-based Chemotherapy
Authors: Fabi Alessandra , Hager Steven , Lourdes Laura , Pedersini Rebecca , Malaguti Paola , Gavioli Elizabeth M. , Wakade Renuka , Ruffini Pier Adelchi , Sergio Francesco , Leone Manuela , Mantelli Flavio , Allegretti Marcello , Blaes Anne 
Published: March 2023

Abstract
Introduction: Cancer-related fatigue (CRF) is a common symptom in patients with metastatic breast cancer (MBC), who receive taxane-based chemotherapy, and is associated with poor outcomes. Current guidelines recommend regular screening for fatigue from the time of cancer diagnosis, during treatment, and after treatment is completed to identify CRF early, lessen its negative impact on quality of life, and prevent potential treatment interruptions. Fatigue is a subjective symptom and is assessed through patient questionnaires such as the FACIT-Fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) survey. However, there is currently no gold standard or recommended survey to assess CRF. Methods: A prospective, non-interventional, multicenter trial is ongoing to validate the FACIT-Fatigue scale in patients with locally advanced or metastatic breast cancer who are eligible to receive taxane-based chemotherapy. Adult patients who have documented locally advanced or metastatic breast cancer (not amenable to surgical resection), and mild-to-moderate CRF indicated by a score of 1 to 6 on a scale from 0 to 10 (10 being most severe), who are candidates to receive cycle one of taxane chemotherapy will be included. Patients who are unable to take oral medications, have other cancer-related causes of fatigue, are using oral morphine ≥60 mg/day, or are participating in another clinical trial will be excluded. The primary objective is to evaluate the change in FACIT-Fatigue scores at baseline and at the end of the study (16 weeks). Secondary endpoints include evaluation of quality-of-life outcomes. A subgroup of patients will participate in a phone-based cognitive interview at the end of study visit or within 2 weeks of this visit to explore fatigue factors deemed important to patients. Results: The total planned sample size is estimated to be 60 patients to allow for a minimum clinically important difference (MCID) with a minimum precision of 1.9 points, and standard deviation of 3 points. The qualitative assessment will be conducted as part of a substudy inclusive of data from 30 patients. Conclusions: This study is currently ongoing to determine the MCID in FACIT-Fatigue scores in patients with locally advanced or MBC receiving treatment with taxane-based chemotherapy. Contact usmedinfo@dompe.com for information related to clinical trial sites and this study.
Citation Format: Alessandra Fabi, Steven Hager, Laura Lourdes, Rebecca Pedersini, Paola Malaguti, Elizabeth M. Gavioli, Renuka Wakade, Pier Adelchi Ruffini, Francesco Sergio, Manuela Leone, Flavio Mantelli, Marcello Allegretti, Anne Blaes. Trial In Progress: An Evaluation of FACIT-Fatigue in Patients with Locally Advanced or Metastatic Breast Cancer receiving Treatment with Taxane-based Chemotherapy [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr OT1-16-01.