Circulating Tumor Cells to Guide Chemotherapy for Metastatic Breast Cancer

Study Overview
=================
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.

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

Conditions
-----------------
Breast Cancer Ductal Infiltrating Metastatic

Intervention / Treatment
-----------------
* Biological: Blood sampling
* Other: Usual clinical and radiological criteria


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Circulating Tumor Cells<br>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. | Biological: Blood sampling<br>* 20ml of patient peripherical blood will be collected<br>|
| Other: Clinical and radiological criteria<br>Management of chemotherapy according to the usual clinical and radiological criteria adopted by the patient's attending physician. | Other: Usual clinical and radiological criteria<br>* Clinical examination, tumoral evaluation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Overall survival (from date of randomization | 7 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of safety and tolerability | A list of the most frequent toxicity was established. The ranks 3 and 4 will be more specificaly collected. | 7 years | 
| Improvement of quality of life |  | 7 years | 
| Time to progression, to discontinuation of therapy after 3rd line. |  | 7 years | 
| Comparison of CTC with usual serum tumour markers |  | 7 years | 
| Medico-economical analysis |  | 5 years | 
| Estimate the clinical interest, in particular forecast, of the circulating tumoral DNA |  | 3 years |