Abstract
BackgroundCirCe01 trial aimed to assess the clinical utility of circulating tumour cell (CTC)-based monitoring in metastatic breast cancer (MBC) patients beyond the third line of chemotherapy (LC).MethodsCirCe01 was a prospective, multicentre, randomised trial (NCT01349842) that included patients with MBC after two systemic LC. Patients with ≥5 CTC/7.5 mL (CellSearch®) were randomised between the CTC-driven and the standard arm. In the CTC arm, changes in CTC count were assessed at the first cycle of each LC; patients in whom CTC levels predicted early tumour progression had to switch to a subsequent LC.ResultsGreater than or equal to 5 CTC/7.5 mL were observed in N = 101/204 patients. In the CTC arm (N = 51), 43 (83%) and 18 (44%) patients completed CTC monitoring in the third and fourth lines, respectively, and 18 (42%) and 11 (61%) of these patients, respectively, had no CTC response. Thirteen (72%) and 5 (46%) of these patients underwent early switch to the next LC. Overall survival was not different between the two arms (hazard ratio = 0.95, 95% confidence interval = [0.6;1.4], p = 0.8). In subgroup analyses, patients with no CTC response who switched chemotherapy experienced longer survival than patients who did not.ConclusionsDue to the limited accrual and compliance, this trial failed to demonstrate the clinical utility of CTC monitoring.Clinical Trial RegistrationNCT, NCT01349842, https://clinicaltrials.gov/ct2/show/NCT01349842, registered 9 May 2011.
Highlights
CirCe01 trial aimed to assess the clinical utility of circulating tumour cell (CTC)-based monitoring in metastatic breast cancer (MBC) patients beyond the third line of chemotherapy (LC)
While HER2+ and triple-negative MBC patients are treated with frontline chemotherapy, ER+ HER2− MBC patients are treated with first-line endocrine therapy, possibly followed by chemotherapy after the onset of overt endocrine resistance.[3]
We report here the results of CirCe01, a CTC-based prospective trial conducted in the late-line setting, 1Department of Medical Oncology, Institut Curie, Paris, France; 2Department of Medical Oncology, Institut Curie, Saint Cloud, France; 3Circulating Tumor Biomarkers Laboratory, SIRIC2 Institut Curie, Paris, France; 4UVSQ, Université Paris-Saclay, Saint Cloud, France; 5Department of Biostatistics, Institut Curie, PSL Research University, Saint Cloud, France; 6Department of Medical Oncology, Centre Jean Bernard, Le Mans, France; 7Department of Medical Oncology, CHU de Limoges, Limoges, France; 8Department of Medical Oncology, CLCC Georges François Leclerc, Dijon, France; 9Department of Medical Oncology, Institut de cancérologie de l’Ouest, Saint-Herblain, France and 10Université de Paris, Paris, France Correspondence: Francois-Clement Bidard
Summary
CirCe01 trial aimed to assess the clinical utility of circulating tumour cell (CTC)-based monitoring in metastatic breast cancer (MBC) patients beyond the third line of chemotherapy (LC). Further analyses showed that CTC changes 3–5 weeks after the initiation of a new line of chemotherapy, using the same cut-off, were associated with treatment efficacy.[11]. Based on these clinical validity data, the CellSearch® system was approved by the US Food and Drug Administration as an aid to the monitoring of patients with MBC. The early change of CTC count was confirmed as a prognostic marker by other studies worldwide and eventually became a level-of-evidence 1 prognostic biomarker following the European Pooled Analysis of CTC (EPAC12) A combination of EPAC and American data further substantiated the clinical validity of CTC count in MBC.[13]
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