A Phase 3 interventional study of Blood sampling and Usual clinical and radiological criteria in Breast Cancer Ductal Infiltrating Metastatic, sponsored by Institut Curie. Completed at 7 sites in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-24.
Sponsored by Institut Curie · Phase 3, Interventional, and Diagnostic
Evaluation of the use of Circulating tumour Cells to guide chemotherapy from the 3rd line of chemotherapy for metastatic breast cancer.
Phase III multicentre, randomized, open-label study comparing early evaluation of the efficacy of chemotherapy by determination of circulating tumour cells versus conventional clinical and radiological evaluation.
Institut Curie is the lead sponsor of 134 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Centralized determination of CTC by CellSearch® technology (Veridex), the only technology currently validated in clinical practice for the early evaluation of response to chemotherapy of breast cancers. This evaluation is performed by blood sampling comparing the CTC level before the first injection of each new line of chemotherapy. Chemotherapy can only be continued in the case of a positive CTC response. Discontinuation of chemotherapy can also be decided by the clinician on the basis of other clinical or radiological arguments.
Biological: Blood sampling
Management of chemotherapy according to the usual clinical and radiological criteria adopted by the patient's attending physician.
Other: Usual clinical and radiological criteria
20ml of patient peripherical blood will be collected
Clinical examination, tumoral evaluation
Overall Survival
Overall survival (from date of randomization
Time frame: 7 years
Measure of safety and tolerability
A list of the most frequent toxicity was established. The ranks 3 and 4 will be more specificaly collected.
Time frame: 7 years
Improvement of quality of life
Time frame: 7 years
Time to progression, to discontinuation of therapy after 3rd line.
Time frame: 7 years
Comparison of CTC with usual serum tumour markers
Time frame: 7 years
Medico-economical analysis
Time frame: 5 years
Estimate the clinical interest, in particular forecast, of the circulating tumoral DNA
Time frame: 3 years
Plan to share: No
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Institut Curie