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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Circulating Tumor Cells | Experimental | 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. |
|
| Clinical and radiological criteria | Other | Management of chemotherapy according to the usual clinical and radiological criteria adopted by the patient's attending physician. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling | Biological | 20ml of patient peripherical blood will be collected |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival (from date of randomization | 7 years |
| Measure | Description | Time Frame |
|---|---|---|
| Measure of safety and tolerability | A list of the most frequent toxicity was established. The ranks 3 and 4 will be more specificaly collected. | 7 years |
| Improvement of quality of life | 7 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| PIERGA Jean-Yves, MD | Institut Curie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Georges Francois Leclerc | Dijon | 21079 | France | |||
| Clinique Victor Hugo |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33473163 | Background | Cabel 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. | |
| 25700777 |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Usual clinical and radiological criteria | Other | Clinical examination, tumoral evaluation |
|
| Time to progression, to discontinuation of therapy after 3rd line. | 7 years |
| Comparison of CTC with usual serum tumour markers | 7 years |
| Medico-economical analysis | 5 years |
| Estimate the clinical interest, in particular forecast, of the circulating tumoral DNA | 3 years |
| Le Mans |
| 72000 |
| France |
| Chu Limoges | Limoges | 87042 | France |
| Institut Curie | Paris | 75005 | France |
| Hopital Saint Louis | Paris | 75475 | France |
| Institut Rene Huguenin Curie | Saint-Cloud | 92210 | France |
| Institut de Canacerologie de L'Ouest | Saint-Herblain | 44805 | France |
| Result |
| Helissey 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. |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |