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Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care

715 - Autoimmunity and benefit from trastuzumab treatment in breast cancer: results from the HERA phase 3 trial


22 Oct 2018


Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care



Tumour Site

Breast Cancer


Amir Sonnenblick


Annals of Oncology (2018) 29 (suppl_8): viii58-viii86. 10.1093/annonc/mdy270


A. Sonnenblick1, A. Bailey2, B. Uziely3, M. Untch4, I. Smith5, L. Gianni6, J. Baselga7, C. Jackisch8, D. Cameron9, R. Bell10, D. Zardavas11, N. Al-Sakaff12, R. Gelber13, M. Dowsett14, B. Leyland-­jones15, M. Piccart16, E. de Azambuja17

Author affiliations

  • 1 Oncology, Tel Aviv Sourasky Medical Center, 00000 - Tel Aviv/IL
  • 2 Frontier Science, Frontier Science, 00000 - Kingussie/GB
  • 3 Oncology, Hadassah Medical Center, 00000 - Jerusalem/IL
  • 4 Clinic For Gynecology, Gynecologic Oncology And Obstetrics, Helios Klinikum Berlin Buch, 13125 - Berlin/DE
  • 5 Oncology, Royal Marsden Hospital NHS Foundation Trust, SW3 6JJ - London/GB
  • 6 Oncology, IRCCS San Raffaele, 20132 - Milan/IT
  • 7 Oncology, Memorial Sloan-Kettering Cancer Center, 10065 - New York/US
  • 8 Gynecology And Obstetrics, Klinikum Offenbach GmbH, 63069 - Offenbach/DE
  • 9 Oncology, Edinburgh Cancer Centre Western General Hospital, LS9 7TF - Edinburgh/GB
  • 10 Deakin University, Deakin University Waurn Ponds, 3220 - Geelong/AU
  • 11 Breast International Group, Breast International Group, 1000 - Brussels/BE
  • 12 F. Hoffmann-la Roche Ag - Switzerland, F. Hoffmann-La Roche AG - Switzerland, 4070 - Basel/CH
  • 13 Department Of Biostatistics And Computational Biology, Dana-Farber Cancer Institute, 2215 - Boston/US
  • 14 Royal Marsden Hospital, Academic Department of Biochemistry, SW3 6JJ - London/GB
  • 15 Department Of Molecular And Experimental Medicine, Avera Cancer Institute, Sioux Falls/US
  • 16 Medicine, Institute Jules Bordet, 1000 - Brussels/BE
  • 17 Oncology, Institute Jules Bordet, 1000 - Brussels/BE


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Abstract 715


A growing body of evidence demonstrates that the immune system contributes to the therapeutic effects of trastuzumab. We sought to determine whether autoimmune background could identify patients with HER2 positive early breast cancer (EBC) who derive differential benefit from adjuvant primary trastuzumab-based therapy.


HERA (BIG 1-01) is an international, multicenter, open-label, phase 3 randomized trial of 5,102 women with HER2-positive EBC, who were enrolled after completion of their postoperative chemotherapy to receive trastuzumab for 1 year, 2 years, or no trastuzumab. In this exploratory analysis, we evaluated whether there is an interaction between autoimmune history and the magnitude of trastuzumab benefit with respect to disease-free survival (DFS) and overall survival (OS).


A total of 5,099 patients were included in the current analysis: 4,774 patients (93.6%) had no history of autoimmune disease at baseline while 325 patients (6.4%) had autoimmune disease history, 295 of whom had active disease. Median follow-up was 11 years (IQR 10.09–11.53); 1,631 patients experienced a DFS event and 1,037 patients experienced an OS event. Random assignment to 1 or 2 years of trastuzumab compared with no trastuzumab yielded similar reductions in the risk of events for patients with no autoimmune history as for patients with autoimmune history (interaction p = 0.95 for DFS, and p = 0.62 for OS). Trastuzumab reduced the risk of DFS event for both the no autoimmune (HR 0.77, 95% CI 0.69–0.85) as well as the autoimmune history group (HR 0.76, 95% CI 0.51–1.12). The risk of death was also similarly reduced for both groups: no autoimmune history: (HR 0.74, 95% CI 0.65-0.84); autoimmune history: (HR 0.65, 95% CI 0.40-1.07).


We found no evidence of a differential benefit from trastuzumab in patients with a medical history of autoimmune disease.

Clinical trial identification

Legal entity responsible for the study

BrEAST - Amir Sonnenblick.


HERA was conducted under the umbrella of the Breast international group (BIG), with sponsorship and funding provided by F Hoffmann-La Roche.

Editorial Acknowledgement


C. Jackisch: Advisory board: Roche; Travel grants: Roche. D. Zardavas: Research grants; Roche, Genentech, Pfizer, AstraZeneca. N. Al-Sakaff: Employment: F. Hoffmann-La Roche. R. Gelber: Contributions to clinical trials: Roche, Novartis, Pfizer, AstraZeneca, Ipsen, Ferring, GSK, Celgene. M. Piccart: Consultancy fees: Roche. E. de Azambuja: Research grant, Advisory board and honoraria: Roche; Travel grants: Roche / GSK. All other authors have declared no conflicts of interest.

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