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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
265
20ml of patient peripherical blood will be collected
Clinical examination, tumoral evaluation
Centre Georges Francois Leclerc
Dijon, France
Clinique Victor Hugo
Le Mans, France
Chu Limoges
Limoges, France
Institut Curie
Paris, France
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
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Hopital Saint Louis
Paris, France
Institut Rene Huguenin Curie
Saint-Cloud, France
Institut de Canacerologie de L'Ouest
Saint-Herblain, France