Abstract OT3-01-03: Phase III clinical trial to evaluate patient's preference for subcutaneous (SC) versus intravenous (IV) trastuzumab administration in patients with HER2 positive, advanced breast cancer (ABC) under IV trastuzumab treatment for at least 4 months and without disease progression. ChangHER-SC study (GEICAM/2012-07)
Authors: Ciruelos E , González E , Lluch A , Garrigós L , Quiroga V , Antón A , Pascual T , Montaño Á , Angulo MdM , Cámara MdC , Amigo Y , Carrasco E , Casas A 
Published: May 2016

Abstract
Background: Patients with HER2-positive, ABC, usually receive anti-HER2 treatment for several months or even years. Trastuzumab IV is administered weekly or 3-weekly, mandating patients to visit the hospital on a regular basis to receive infusions that are prepared in the hospital's pharmacy and administered to patients over 30-90 minutes. These mean some inconveniences for the patients and increase treatment costs. Subcutaneous administration could improve convenience of trastuzumab treatment. This study was designed to evaluate patient's preference for IV or SC trastuzumab.
Trial Design: Phase III, open label, multicenter study, running in 27 Spanish sites. HER2 positive, ABC patients, receiving IV trastuzumab (in monotherapy or in any combination), without evidence of disease progression for at least 4 months, and a life expectancy of at least 3 months, are eligible. Patients are randomized to receive SC trastuzumab, either from a vial or from a single injection device (SID), at a fixed dose of 600 mg, every 3 weeks, for 4 cycles. Before starting SC administration, patients receive an additional IV cycle. Patients in arm A receive 2 SC cycles using the vial and then two cycles more with the SID. In arm B patients receive the opposite sequence. After these four cycles, patients continue with SC or IV trastuzumab, depending on their decision, until disease progression. The primary objective is to evaluate patient's preference for IV or SC trastuzumab and, secondary objectives are, to evaluate patient's preference for the SC administration using the vial or the SID, the Health Care Professional satisfaction, the associated costs of the different administration options (with a Time and Motion pharmaco-economic study) and the safety of the different treatment administrations. Assuming a 65% rate of patients preferring SC trastuzumab and with a precision ±7.5%, a total of 195 patients have to be recruited to allow for a 20% of expected drop-out rate. Recruitment started in September 2013 and 158 patients have been included so far. Analysis of the primary endpoint will take place once the last patient has completed the 4 cycles of the study treatment. (ClinTrials.gov reference NCT01875367).
Citation Format: Ciruelos E, González E, Lluch A, Garrigós L, Quiroga V, Antón A, Pascual T, Montaño Á, Angulo MdM, Cámara MdC, Amigo Y, Carrasco E, Casas A. Phase III clinical trial to evaluate patient's preference for subcutaneous (SC) versus intravenous (IV) trastuzumab administration in patients with HER2 positive, advanced breast cancer (ABC) under IV trastuzumab treatment for at least 4 months and without disease progression. ChangHER-SC study (GEICAM/2012-07). [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr OT3-01-03.