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Poster display

1338 - Adjuvant subcutaneous trastuzumab for HER2-positive early breast cancer: Phase III SafeHer study subgroup analyses of body weights, active medical conditions, safety and tolerability


10 Oct 2016


Poster display


Kyung Hae Jung


Annals of Oncology (2016) 27 (6): 43-67. 10.1093/annonc/mdw364


K.H. Jung1, B. Ataseven2, M. Verrill3, X. Pivot4, M. De Laurentiis5, N. Al-Sakaff6, S. Lauer7, M. Shing8, J. Gligorov9, H.A. Azim10

Author affiliations

  • 1 Department Of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 05505 - Seoul/KR
  • 2 Department Of Gynecology And Gynecologic Oncology, Kliniken Essen-Mitte, Essen/DE
  • 3 Medical Oncology Department, Northern Centre for Cancer Care, Newcastle upon Tyne/GB
  • 4 Chemotherapy – Oncology, CHU Jean Minjoz, Besançon/FR
  • 5 Breast Oncology Department, National Cancer Institute “Fondazione Pascale”, Naples/IT
  • 6 Global Pharma Development, F. Hoffmann-La Roche Ltd, Basel/CH
  • 7 Biostatistics, F. Hoffmann-La Roche Ltd, Basel/CH
  • 8 Global Pharma Development, Genentech, Inc., South San Francisco/US
  • 9 Medical Oncology Department, APHP-Tenon; IUC-UPMC; Sorbonne University, Paris/FR
  • 10 Clinical Oncology Department, Cairo University, Cairo/EG


Abstract 1338


The Phase III, non-randomised, multinational, open-label SafeHer study (NCT01566721) confirmed the safety and tolerability profile of 600 mg fixed-dose subcutaneous trastuzumab (Herceptin® SC [H SC]), administered every 3 weeks (q3w) for 18 cycles/1 year from an H SC Vial via hand-held syringe or from a single-use injection device (SID), as adjuvant therapy for HER2-positive early breast cancer (Gligorov J, et al. EBCC 2016; P326). The safety and tolerability of H SC 600 mg fixed-dose therapy may be affected by patients' body weights and active medical conditions, especially in patients with lower body weights. We assessed these factors in an exploratory analysis of SafeHer.


Adverse events (AEs) and serious AEs (SAEs) were recorded/graded per National Cancer Institute – Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.0. Congestive heart failure (CHF) was assessed by NCI-CTCAE v4.0/New York Heart Association functional classification. Results are descriptive. Data are from the combined H SC Vial and H SC SID cohorts, from the first H SC dose until 28 days after the last dose (plus a 5-day window). SafeHer study follow-up will continue for 5 years.


Safety and active medical conditions of interest by weight subgroup are shown in the table.

Patients, n (%) Overall N = 2573 Very- low weight 59– ≤ 67 kg n = 641 Quartile 3 >67– ≤ 77 kg n = 625 Quartile 4 >77 kg n = 623
Any grade AE 2282 (89)1 36 (90) 258 (88) 590 (87) 566 (88) 558 (89) 561 (90)
Grade ≥3 AE 596 (23)1 8 (20) 54 (18) 121 (18) 152 (24) 155 (25) 167 (27)
Cardiac disorder 24 (1)1 0 3 (1) 6 (1) 5 (1) 7 (1) 6 (1)
CHF 8 (


In this SafeHer subgroup analysis, the safety results were comparable for the H SC 600 mg q3w fixed dose among the lower-body-weight subgroups and the overall patient population. In the higher-body-weight subgroup, grade ≥3 AE and SAE rates were slightly higher than the overall patient population, which may be influenced by the higher rate of active medical conditions in the higher-body-weight subgroups; nevertheless, grade ≥3 and serious cardiac disorders remained comparable across all weight subgroups.

Clinical trial identification


Legal entity responsible for the study

F. Hoffmann-La Roche Ltd.


F. Hoffmann-La Roche Ltd.


B. Ataseven: Membership of an advisory board (Roche). Other substantive relationships (honorarium for lectures: Roche, AstraZeneca; Travel expenses support: Roche). M. Verrill: Stock ownership (Roche, Bayer); Membership of an advisory board (Roche, Celgene, AstraZeneca, Novartis, Pfizer, Teva, Chugai); Corporate-sponsored research (Roche, Novartis, Amgen). X. Pivot: Consultant with honorarium for Roche, Amgen, Novartis, Eisai, Pierre Fabre. M. De Laurentiis: Membership of an advisory board (Roche, Novartis, Celgene, Pfizer, Eisai). N. Al-Sakaff: Stock ownership (Roche). Employee of Roche.

S. Lauer: Other substantive relationships (contract work for F. Hoffmann-La Roche). M. Shing: Other substantive relationships (Employee of Genentech, Inc.). J. Gligorov: Consultancy: Roche-Genentech; Eisai Honoraria: Teva; Novartis-GSK; GenomicHealth. H.A. Azim: Membership of an advisory board (Roche, Pfizer, Novartis & Amgen); Corporate-sponsored research (Bayer & Pfizer). All other authors have declared no conflicts of interest.

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