Abstract OT1-12-09: Time and motion study of a subcutaneous fixed-dose combination of pertuzumab and trastuzumab for the treatment of patients with HER2-positive early breast cancer (PHaTiMa)
Authors: Gregori Joaquín Gavilá , Miranda Elena López , Escrivá-de-Romaní Santiago , Rodríguez Begoña Jiménez , Novoa Silvia Antolín , Morales Luis Fernández , Calvo Elena Galve , Cortijo Lucía González , Martorell Antonia Perelló , Ruiz Julián Lagunar , Santiago Santiago González 
Published: March 2022

Abstract
Type: Trial in progress. Introduction: Sequential intravenous (IV) treatment with pertuzumab and trastuzumab is effective in disrupting HER2 signalling in early and advanced HER2-positive breast cancer (BC). However, this strategy increases patient’s length of stay at the hospital, healthcare professionals’ (HCP) workload, and the use of medical supplies and resources. The change from IV to subcutaneous (SC), and the combination of fixed doses of pertuzumab and trastuzumab in a unique ready-to-use vial is expected to save HCP and patient time, release resources and reduce the utilization of medical supplies. Moreover, reducing patient chair time and hospital time would improve their quality of life, help reduce indirect costs due to less work productivity loss and decrease patient exposure to nosocomial pathogens. This is the first randomized clinical trial capturing the time and resources associated with the fixed-dose combination of pertuzumab and trastuzumab for SC injection (PH FDC SC) compared with Perjeta (P) IV and Herceptin (H) IV/SC. Design: Multicentre, interventional, randomized Phase IIIb clinical trial that aims to recruit 33 adult patients with node-positive HER2-positive early BC from 10 centres across Spain. These patients will have been previously treated with neoadjuvant P + H + chemotherapy according to local practice and achieved a pathological complete response (pCR, defined as ypT0/is ypN0) after surgery. Patients will be randomized 1:1 to receive either P IV + H IV (group A) or P IV + H SC (group B), every 3 weeks (Q3W) for 4 cycles followed by PH FDC SC Q3W for 3 cycles. Primary endpoints are to evaluate the patient time in the care unit for each administration route, and the HCP time for SC and IV processes on a per patient visit and per complete treatment. Secondary endpoints comprise total patient time spent in hospital and resource utilization reduction in terms of consumables and drug wastage, for the different administration routes. Quantification of HCP and patient times, and utilization of resources will be calculated from cycles 2 to 7 of adjuvant treatment. In subsequent cycles, patients will continue PH FDC SC Q3W up to a total of 18 cycles (including neoadjuvant anti-HER2 treatment cycles) unless they choose to switch back to IV formulations. Time will be disaggregated per pre-specified tasks and per HCP. Patient chair time and treatment-room time will be assessed. Trained staff observers will conduct time measurements using a stopwatch, interview patients to determine hospital time, and record predictors of activity time. This study is registered at EudraCT 2020-004241-36.
Citation Format: Joaquín Gavilá Gregori, Elena López Miranda, Santiago Escrivá-de-Romaní, Begoña Jiménez Rodríguez, Silvia Antolín Novoa, Luis Fernández Morales, Elena Galve Calvo, Lucía González Cortijo, Antonia Perelló Martorell, Julián Lagunar Ruiz, Santiago González Santiago. Time and motion study of a subcutaneous fixed-dose combination of pertuzumab and trastuzumab for the treatment of patients with HER2-positive early breast cancer (PHaTiMa) [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr OT1-12-09.