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Poster display session

5522 - Anti-HER2 therapy efficacy in HER2-negative metastatic breast cancer with HER2-amplified circulating tumor cells: results of the CirCe T-DM1 trial


11 Sep 2017


Poster display session


Francois-Clement Bidard


Annals of Oncology (2017) 28 (suppl_5): v22-v42. 10.1093/annonc/mdx363


F. Bidard1, P. cottu1, C. Dubot2, L. Venat-Bouvet3, A. Lortholary4, H. Bourgeois5, M. Bollet6, V. Servent Hanon7, E. Luporsi-Gely8, M. Espie9, S. Guiu10, V. D'Hondt11, V. Dieras1, M.P. Sablin1, S. Neffati1, F. Berger1, J. Pierga1, W. Jacot11

Author affiliations

  • 1 Medical Oncology, Institut Curie, 75005 - Paris/FR
  • 2 Medical Oncology, Hôpital René Huguenin - Institut Curie, 92210 - St. Cloud/FR
  • 3 Medical Oncology, limoges university hospital, 12000 - limoges/FR
  • 4 Medical Oncology, Centre Catherine de Sienne, 44202 - Nantes/FR
  • 5 Medical Oncology, Clinique Victor Hugo Le Mans, 72000 - Le Mans/FR
  • 6 Radiation Oncology, Clinique Hartmann, 92300 - Levallois-Perret/FR
  • 7 Medical Oncology, Centre Oscar Lambret, 59020 - Lille/FR
  • 8 Medical Oncology, Institut de Cancérologie de Lorraine - Alexis Vautrin, 54519 - Vandoeuvre les Nancy/FR
  • 9 Medical Oncology, Hôpital St. Louis, 75010 - Paris/FR
  • 10 Medical Oncology, institut de cancerologie de montpellier, 34000 - montpellier/FR
  • 11 Medical Oncology, ICM Regional Cancer Institute of Montpellier, 34298 - Montpellier/FR


Abstract 5522


Changes of HER2 status has been reported in circulating tumor cells (CTC) isolated from preclinical models and metastatic breast cancer (MBC) patients. The prospective multicentric phase II “CirCe T-DM1” trial was set up to assess whether HER2-amplified CTC are detectable in HER2-negative MBC and whether these cancers would respond to anti-HER2 therapy.


HER2-amplified CTC were screened in HER2-negative (HER2-/ER- and HER2-/ER+) MBC patients starting a 3rd line or 4th line of systemic therapy. CTC were detected by CellSearch® (Janssen Diagnostics) and FISH was performed on isolated CTCs. HER2-amplification was defined by a HER2/CEP17 ratio ≥2.2. Patients with ≥1 HER2-amplified CTC, measurable disease and adequate organ function were eligible. After stratification according to amplified CTC count (< vs ≥ 3), patients received single agent T-DM1. The primary endpoint of the study was the response rate by RECIST criteria.


From 11/2013 to 08/2016, 155 MBC patients were screened. 11 (9.2%) and 3 patients (2.5%) had 1-2 and ≥3 HER2-amplified CTCs respectively (minimal HER2/CEP17 ratio: 2.5). In the 14 patients with HER2-amplified CTC, the fraction of HER2-amplified CTCs among all detected CTCs was low (median 1.6%, range [0.3%-35.3%]), and presence of HER2-amplified CTCs was not associated with any patients’ characteristics. 11 patients were treated with single agent T-DM1. Partial response was confirmed in one patient with 1 HER2-amplified CTC (among 9 CTC detected); median PFS was 4.9 months (range: 1.8-10.1).


This study shows that CTCs with a true HER2-amplification can be detected in advanced HER2-negative MBC, mostly as a minor CTCs subset. Although one confirmed response was observed in our study, the overall low response rate to specific anti-HER2 therapy does not support the clinical utility of such strategy in that setting.

Clinical trial identification


Legal entity responsible for the study

Institut Curie




All authors have declared no conflicts of interest.

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