Circulating Tumor Cells to Guide Chemotherapy for Metastatic Breast Cancer (CirCé01)
Breast Cancer Ductal Infiltrating Metastatic
About this trial
This is an interventional diagnostic trial for Breast Cancer Ductal Infiltrating Metastatic
Eligibility Criteria
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.
Sites / Locations
- Centre Georges Francois Leclerc
- Clinique Victor Hugo
- Chu Limoges
- Institut Curie
- Hopital Saint Louis
- Institut Rene Huguenin Curie
- Institut de Canacerologie de L'Ouest
Arms of the Study
Arm 1
Arm 2
Experimental
Other
Circulating Tumor Cells
Clinical and radiological 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.
Management of chemotherapy according to the usual clinical and radiological criteria adopted by the patient's attending physician.