315TiP - SAFEHER: a study of assisted- and self-administered subcutaneous trastuzumab (H-SC) as adjuvant therapy in patients with early HER2-positive breast...

Date 01 October 2012
Event ESMO Congress 2012
Session Poster presentation III
Topics Cytotoxic agents
Breast Cancer
Therapy
Biological therapy
Presenter Joseph Gligorov
Authors J. Gligorov1, H.A. Azim2, B. Ataseven3, M. Delaurentiis4, K.H. Jung5, F. Herbst6, A. Llombart Cussac7, A. Manikhas8, S. Osborne9, X. Pivot10
  • 1Oncologie Medicale, Tenon Hospital, Paris/FR
  • 2Clinical Oncology Department, Cairo University, Cairo/EG
  • 3Rot-Kreuz-Klinikum, Munich/DE
  • 4Breast Oncology Department, National Cancer Institute “Fondazione Pascale”, Napoli/IT
  • 5Department Of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul/KR
  • 6Oncology, F. Hoffmann-La Roche Ltd., Basel/CH
  • 7Medical Oncology Service, Hospital Arnau de Vilanova, Valencia/ES
  • 8Oncology, Oncology Hospital of St. Petersburg, St. Petersburg/RU
  • 9Statistics, F. Hoffmann-La Roche Ltd., Basel/CH
  • 10Chimiothérapie – Oncologie, CHU Jean Minjoz, Besançon/FR

Abstract

Purpose

One year of H-based therapy, consisting of 18 q3w cycles, is standard of care for the adjuvant treatment of HER2-positive EBC. H is administered intravenously (IV) over 30–90 mins. An SC formulation of H has been developed, which is rapidly administered (up to 5 mins), potentially improving convenience for patients and clinical staff, and reducing administration costs. The Phase III HannaH study (NCT00950300) demonstrated that the pharmacokinetics and efficacy of H-SC were non-inferior to that of H-IV, meeting the co-primary endpoints. The safety profile of H-SC was comparable and consistent with the known safety profile of H-IV. SafeHer is designed to further evaluate the safety and tolerability of H-SC in a broader patient population; to allow greater understanding of a range of safety data. H-SC will be administered via one of two different routes (handheld syringe [vial formulation] or single-use injection device [SID]; which allows self-administration). Supportive data on SID safety and patient satisfaction with self-administration will be collected.

Methods

SafeHer is a multicentre, international, Phase III open-label trial (NCT01566721). The primary objective is the safety and tolerability of H-SC. Secondary objectives include disease-free survival, overall survival and patient satisfaction with SID administration. Immunogenicity of H and recombinant human hyaluronidase in a subset of patients using the SID at select sites is an exploratory objective. Planned enrolment is 2500 patients, assigned to one of two cohorts at the investigators' discretion ± concurrent/sequential chemotherapy. All patients will receive H-SC at a fixed dose of 600mg regardless of body weight, for a total of 18 cycles (q3w) via injection into the thigh over a period of up to 5 minutes. Patients in cohort A (n = 1800) will receive H-SC using handheld syringes. Patients in cohort B (n = 700) will receive H-SC using an SID, first via assisted administration and then self-administered (in select patients).

Enrolment began in May 2012 and parallel substudies may be performed at selected centres to evaluate medical resource utilisation (“time and motion study”).

Disclosure

J. Gligorov: I disclose potential conflict of interest : advisory boards and speaker honoraria for Roche laboratories.

H.A. Azim: I serve on the advisory board of Roche in the middle east.

B. Ataseven: I am a Roche International Steering Committee member for the SafeHer trial. I have received speaker honoraria from Roche for giveing lectures. I participated in and received a travel grant from Roche for SABCS 2011.

M. Delaurentiis: I am a member of a Roche Advisory Board.

F. Herbst: I am an employee of, and am a stockholder in, F. Hoffmann-La Roche.

A. Llombart: I am a member of a Roche Advisory Board.

S. Osborne: I am an employee of Roche.

X. Pivot: I am a member of Roche and GSK Advisory Boards.

All other authors have declared no conflicts of interest.