Circulating Tumor Cells to Guide Chemotherapy for Metastatic Breast Cancer (CirCé01)

Institut Curie

Status and phase: Completed; Phase 3

Conditions: Breast Cancer Ductal Infiltrating Metastatic

Treatments: Other: Usual clinical and radiological criteria; Biological: Blood sampling

Study type: Interventional

Funder types: Other

Identifiers

NCT01349842

IC 2009-03

Details and patient eligibility

About

Evaluation of the use of Circulating tumour Cells to guide chemotherapy from the 3rd line of chemotherapy for metastatic breast cancer.

Full 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.

Enrollment: 265 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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265 participants in 2 patient groups

Circulating Tumor Cells

Experimental group

Description:

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.

Treatment:

Biological: Blood sampling

Clinical and radiological criteria

Other group

Description:

Management of chemotherapy according to the usual clinical and radiological criteria adopted by the patient's attending physician.

Treatment:

Other: Usual clinical and radiological criteria