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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by Institut Curie
Information provided by (Responsible Party):
Institut Curie Identifier:
First received: May 5, 2011
Last updated: April 23, 2015
Last verified: April 2015
Evaluation of the use of Circulating tumour Cells to guide chemotherapy from the 3rd line of chemotherapy for metastatic breast cancer.

Condition Intervention Phase
Breast Cancer Ductal Infiltrating Metastatic
Biological: Blood sampling
Other: Usual clinical and radiological criteria
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:

Further study details as provided by Institut Curie:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 7 years ] [ Designated as safety issue: No ]
    Overall survival (from date of randomization

Secondary Outcome Measures:
  • Measure of safety and tolerability [ Time Frame: 7 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Time to progression, to discontinuation of therapy after 3rd line. [ Time Frame: 7 years ] [ Designated as safety issue: No ]
  • Comparison of CTC with usual serum tumour markers [ Time Frame: 7 years ] [ Designated as safety issue: No ]
  • Medico-economical analysis [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Estimate the clinical interest, in particular forecast, of the circulating tumoral DNA [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 568
Study Start Date: January 2010
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cells tumoral circulating
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.
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

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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01349842

Contact: TRESCA Patricia, UGEC Leader 33156245630

Centre Georges Francois Leclerc Recruiting
Dijon, France, 21079
Contact: Sylvain LADOIRE, DR         
Principal Investigator: Sylvain LADOIRE, DR         
Clinique Victor Hugo Recruiting
Le Mans, France, 72000
Contact: HUGUES BOURGEOIS, MD         
Principal Investigator: HUGUES BOURGEOIS, MD         
Chu Limoges Recruiting
Limoges, France, 87042
Contact: Nicole TUBIANA-MATHIEU, DR         
Principal Investigator: Nicole TUBIANA-MATHIEU, DR         
Institut Curie Recruiting
Paris, France, 75005
Contact: Jean-Yves PIERGA, DR   
Principal Investigator: Jean-Yves PIERGA, Pr         
Hopital Saint Louis Recruiting
Paris, France, 75475
Contact: Sylvie GIACCHETTI, DR         
Principal Investigator: Sylvie GIACCHETTI, Dr         
Institut Rene Huguenin Curie Recruiting
Saint Cloud, France, 92210
Contact: Etienne BRAIN, DR         
Principal Investigator: Etienne BRAIN, DR         
Institut de cancérologie de l'Ouest Recruiting
Saint-herblain, France, 44805
Contact: Mario CAMPONE, DR         
Principal Investigator: Mario CAMPONE, DR         
Sponsors and Collaborators
Institut Curie
Principal Investigator: PIERGA Jean-Yves, MD Institut Curie
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Institut Curie Identifier: NCT01349842     History of Changes
Other Study ID Numbers: IC 2009-03 
Study First Received: May 5, 2011
Last Updated: April 23, 2015
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Breast Neoplasms
Neoplastic Cells, Circulating
Breast Diseases
Neoplasm Metastasis
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Skin Diseases processed this record on May 02, 2016