HANNAH (NCT00950300) and PREFHER (NCT01401166) international, randomised studies validated the subcutaneous (SC) formulation of trastuzumab as effective and safe as intravenous (IV) and highly preferred by patients in early breast cancer. The present randomized Metaspher trial (NCT 01810393) assessed patient's preference in metastatic setting.
Patients with HER2-positive metastatic breast cancer who completed a first line chemotherapy with trastuzumab (IV) and achieved a long term response lasting more than 3 years were randomised to receive 3 cycles of 600 mg fixed-dose adjuvant trastuzumab SC, followed by 3 cycles of standard IV, or the reverse sequence. Primary endpoint was overall preference for SC or IV at cycle 6, assessed by Patient Preference Questionnaire (PPQ). Secondary endpoints included healthcare professional (HCP) satisfaction, assessed by questionnaire; safety and tolerability, assessed by NCI-CTCAE v4.0; quality of life assessed by QLQ C30 questionnaire. The modified-Intent-To-Treat population (m-ITT) included patients who received both routes of administration and who completed the last question of PPQ. The safety population included all enrolled patients who received at least one dose of treatment.
113 patients were randomised. SC was preferred by 79/92 evaluable m-ITT patients (85.9%, 95% CI [78.8;93.0]; p
Patients preferred trastuzumab SC. The safety profile was consistent with the known IV profile with no safety concerns raised. Next step will assess the follow up of this cohort of long responder patient with metastatic breast cancer.
Clinical trial identification
Legal entity responsible for the study
X. Pivot: consultant for Roche Amgen Novartis Pierre Fabre Eisai. J-P. Spano: Consultant for Roche.
E. Marc, D. Spaeth: Roche. H. Attar-Rabia, C. Benkamoun, L. Dima-Martinez, N. Esposito: Employed by Roche. J. Gligorov: Consultant for Roche, Novartis, Eisai, Pfizer, Genomic Health. All other authors have declared no conflicts of interest.