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

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.

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.