Clinical trial · Interventional
Circulating Tumor Cells to Guide Chemotherapy for Metastatic Breast Cancer
CirCe01 Study: Evaluation of the Use of Circulating Tumour Cells to Guide Chemotherapy From the 3rd Line of Chemotherapy for Metastatic Breast Cancer
NCT01349842CI-TRIAL-00097804CirCé01completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Evaluation of the use of Circulating tumour Cells to guide chemotherapy from the 3rd line of chemotherapy for metastatic breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Ductal Infiltrating Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sampling | Biological | — | UNRESOLVED |
| Usual clinical and radiological criteria | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Circulating Tumor Cells
- description
- 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.
- interventionNames
- Biological: Blood sampling
- type
- OTHER
- label
- Clinical and radiological criteria
- description
- Management of chemotherapy according to the usual clinical and radiological criteria adopted by the patient's attending physician.
- interventionNames
- Other: Usual clinical and radiological criteria
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women over the age of 18 years. * WHO performance status: 0 to 4. * Metastatic breast cancer. * Progression after 2 lines of chemotherapy with decision to initiate third-line chemotherapy. * Disease evaluable by CTC (CTC-positive before starting chemotherapy). * Histology: lobular or ductal adenocarcinoma. * Information of the patient and signature of the informed consent form by the patient or her legal representative. Exclusion Criteria: * Disease not evaluable by CTC (CTC-negative before starting chemotherapy). * History of other potentially metastatic cancer (stage III or IV cancer) different from breast cancer. * Histology other than lobular or ductal adenocarcinoma. * Pregnant woman, women likely to become pregnant or nursing mothers. * Persons deprived of their freedom or under guardianship. * Women unable to comply with the medical follow-up of the study for geographical, social or mental reasons.
References
Publications (2)
- BACKGROUNDCabel L, Berger F, Cottu P, Loirat D, Rampanou A, Brain E, Cyrille S, Bourgeois H, Kiavue N, Deluche E, Ladoire S, Campone M, Pierga JY, Bidard FC. Clinical utility of circulating tumour cell-based monitoring of late-line chemotherapy for metastatic breast cancer: the randomised CirCe01 trial. Br J Cancer. 2021 Mar;124(7):1207-1213. doi: 10.1038/s41416-020-01227-3. Epub 2021 Jan 21. PMID 33473163
- RESULTHelissey C, Berger F, Cottu P, Dieras V, Mignot L, Servois V, Bouleuc C, Asselain B, Pelissier S, Vaucher I, Pierga JY, Bidard FC. Circulating tumor cell thresholds and survival scores in advanced metastatic breast cancer: the observational step of the CirCe01 phase III trial. Cancer Lett. 2015 May 1;360(2):213-8. doi: 10.1016/j.canlet.2015.02.010. Epub 2015 Feb 17. PMID 25700777