Circulating Tumor Cells to Guide Chemotherapy for Metastatic Breast Cancer (CirCé01)
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|ClinicalTrials.gov Identifier: NCT01349842|
Recruitment Status : Completed
First Posted : May 9, 2011
Last Update Posted : March 21, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Ductal Infiltrating Metastatic||Biological: Blood sampling Other: Usual clinical and radiological criteria||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||265 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||March 2, 2010|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||November 6, 2018|
Experimental: Circulating Tumor Cells
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
20ml of patient peripherical blood will be collected
Clinical and radiological criteria
Management of chemotherapy according to the usual clinical and radiological criteria adopted by the patient's attending physician.
Other: Usual clinical and radiological criteria
Clinical examination, tumoral evaluation
- Overall Survival [ Time Frame: 7 years ]Overall survival (from date of randomization
- Measure of safety and tolerability [ Time Frame: 7 years ]A list of the most frequent toxicity was established. The ranks 3 and 4 will be more specificaly collected.
- 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 ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01349842
|Centre Georges Francois Leclerc|
|Dijon, France, 21079|
|Clinique Victor Hugo|
|Le Mans, France, 72000|
|Limoges, France, 87042|
|Paris, France, 75005|
|Hopital Saint Louis|
|Paris, France, 75475|
|Institut Rene Huguenin Curie|
|Saint Cloud, France, 92210|
|Institut de Canacerologie de L'Ouest|
|Saint-herblain, France, 44805|
|Principal Investigator:||PIERGA Jean-Yves, MD||Institut Curie|
|Responsible Party:||Institut Curie|
|Other Study ID Numbers:||
|First Posted:||May 9, 2011 Key Record Dates|
|Last Update Posted:||March 21, 2019|
|Last Verified:||March 2019|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
Neoplastic Cells, Circulating
Carcinoma, Ductal, Breast
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary