This trial is active, not recruiting.

Condition breast cancer ductal infiltrating metastatic
Treatments blood sampling, usual clinical and radiological criteria
Phase phase 3
Sponsor Institut Curie
Start date January 2010
End date January 2018
Trial size 265 participants
Trial identifier NCT01349842, IC 2009-03


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic
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 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.
blood sampling
20ml of patient peripherical blood will be collected
Management of chemotherapy according to the usual clinical and radiological criteria adopted by the patient's attending physician.
usual clinical and radiological criteria
Clinical examination, tumoral evaluation

Primary Outcomes

Overall Survival
time frame: 7 years

Secondary Outcomes

Measure of safety and tolerability
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

Eligibility Criteria

Female participants at least 18 years old.

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.

Additional Information

Official title CirCe01 Study: Evaluation of the Use of Circulating Tumour Cells to Guide Chemotherapy From the 3rd Line of Chemotherapy for Metastatic Breast Cancer
Principal investigator PIERGA Jean-Yves, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Institut Curie.