Breast Cancer Ductal Infiltrating Metastatic
Conditions
Brief summary
Evaluation of the use of Circulating tumour Cells to guide chemotherapy from the 3rd line of chemotherapy for metastatic breast cancer.
Detailed description
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.
Interventions
BIOLOGICALBlood sampling
20ml of patient peripherical blood will be collected
OTHERUsual clinical and radiological criteria
Clinical examination, tumoral evaluation
Sponsors
Institut Curie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 7 years | Overall survival (from date of randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of quality of life | 7 years | — |
| Time to progression, to discontinuation of therapy after 3rd line. | 7 years | — |
| Measure of safety and tolerability | 7 years | A list of the most frequent toxicity was established. The ranks 3 and 4 will be more specificaly collected. |
| Medico-economical analysis | 5 years | — |
| Estimate the clinical interest, in particular forecast, of the circulating tumoral DNA | 3 years | — |
| Comparison of CTC with usual serum tumour markers | 7 years | — |
Countries
France
Outcome results
None listed