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

This study is currently recruiting participants.
Verified April 2011 by Institut Curie
Sponsor:
Information provided by:
Institut Curie
ClinicalTrials.gov Identifier:
NCT01349842
First received: May 5, 2011
Last updated: May 6, 2011
Last verified: April 2011
History of Changes
  Purpose

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:

U.S. FDA Resources

Further study details as provided by Institut Curie:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Overall survival (from date of randomization


Secondary Outcome Measures:
  • Measure of safety and tolerability [ Time Frame: 4 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: 4 years ] [ Designated as safety issue: No ]
  • Time to progression, to discontinuation of therapy after 3rd line. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Comparison of CTC with usual serum tumour markers [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 568
Study Start Date: January 2010
Estimated Primary Completion Date: January 2014 (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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01349842

Contacts
Contact: MARAL Sylvie, UGEC Leader 33156245632 melanie.lebegue@curie.net

Locations
France
Institut Curie Recruiting
Paris, France, 75005
Contact: MARAL Sylvie, UGEC leader     33156245632     melanie.lebegue@curie.net    
Sponsors and Collaborators
Institut Curie
Investigators
Principal Investigator: PIERGA Jean-Yves, MD Institut Curie
  More Information

No publications provided

Responsible Party: Mme Sylvie MARAL, INSTITUT CURIE
ClinicalTrials.gov Identifier: NCT01349842     History of Changes
Other Study ID Numbers: IC 2009-03
Study First Received: May 5, 2011
Last Updated: May 6, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma, Ductal, Breast
Neoplastic Cells, Circulating
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carcinoma, Ductal
 Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013