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Table 1 Characteristics of screened patients and HER2amp CTC detection

From: Actionability of HER2-amplified circulating tumor cells in HER2-negative metastatic breast cancer: the CirCe T-DM1 trial

Patients characteristicsIncluded pts.
(N = 154)
N (%)
Pts. with ≥1CTC
(N = 118)
N (%)
Pts. with ≥1CTC and interpretable FISHc
(N =79)
N (%)
Pts. with ≥ 1 HER2amp CTC
(N = 14)
N (%)
Age at inclusion
 ≤ 50 years26 (17.0%)18 (15.4%)12 (15.2%)3 (21.4%)
 > 50 years127 (83.0%)99 (84.6%)67 (84.8%)11 (78.6%)
 NA11  
Performance status
 PS 063 (44.4%)40 (37.4%)25 (33.8%)3 (21.4%)
 PS 178 (54.9%)66 (61.7%)48 (64.9%)10 (71.4%)
 PS 21 (0.7%)1 (0.9%)1 (1.4%)1 (7.1%)
 NA12115 
Tumor type
 NST135 (89.4%)103 (88.8%)67 (85.9%)13 (92.9%)
 Lobular13 (8.6%)10 (8.6%)10 (12.8%)1 (7.1%)
 Other3 (2.0%)3 (2.6%)1 (1.3%)0 (0%)
 NA321 
Tumor grade
 Grade I10 (7.4%)9 (8.7%)7 (9.9%)2 (16.7%)
 Grade II80 (59.3%)60 (58.3%)44 (62.0%)6 (50.0%)
 Grade III45 (33.3%)34 (33.0%)20 (28.2%)4 (33.3%)
 NA191582
Receptor status on primary tumor a
 ER− PR− HER2−15 (10.1%)10 (8.9%)6 (8.1%)0 (0%)
 ER+ and/or PR+, HER2−125 (84.5%)98 (87.5%)67 (90.5%)12 (100%)
 Not done8 (5.4%)4 (3.6%)1 (1.4%)0 (0%)
 NA6652
Receptor status on local/distant relapsea
 ER− PR− HER2−17 (19.3%)10 (15.4%)8 (19.5%) 
 ER+ and/or PR+, HER2−63 (71.6%)49 (75.4%)30 (73.2%)7 (87.5%)
 Not done8 (9.1%)6 (9.2%)3 (7.3%)1 (12.5%)
 NA6653386
Number of prior lines of chemotherapyb
 265 (42.8%)46 (39.7%)33 (42.3%)3 (21.4%)
 342 (27.6%)34 (29.3%)20 (25.6%)4 (28.6%)
 ≥ 445 (29.6%)36 (31.0%)25 (32.1%)7 (50.0%)
 NA221 
Number of CTC detected
 Screening CTC = 032 (21.3%)   
 Screening CTC [1–4]32 (21.3%)32 (27.1%)11 (13.9%)0 (0%)
 Screening CTC ≥ 586 (57.3%)86 (72.9%)68 (86.1%)14 (100%)
 NA4   
  1. NST invasive carcinoma of no special type, ER estrogen receptor, PR progesterone receptor
  2. aOne patient with a history of HER2-positive primary tumor was excluded and is not shown in this table
  3. bChemotherapies administered for metastatic disease
  4. cInterpretable FISH results: at least 1 CTC with both HER2 and CEP17 signals observed, with negative internal controls