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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01349842
Recruitment Status : Completed
First Posted : May 9, 2011
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Institut Curie

Study Description
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Brief Summary:
Evaluation of the use of Circulating tumour Cells to guide chemotherapy from the 3rd line of chemotherapy for metastatic breast cancer.

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

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 265 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : March 2, 2010
Actual Primary Completion Date : January 2016
Actual Study Completion Date : November 6, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 7 years ]
    Overall survival (from date of randomization


Secondary Outcome Measures :
  1. 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.

  2. Improvement of quality of life [ Time Frame: 7 years ]
  3. Time to progression, to discontinuation of therapy after 3rd line. [ Time Frame: 7 years ]
  4. Comparison of CTC with usual serum tumour markers [ Time Frame: 7 years ]
  5. Medico-economical analysis [ Time Frame: 5 years ]
  6. Estimate the clinical interest, in particular forecast, of the circulating tumoral DNA [ Time Frame: 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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) 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
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Information from the National Library of Medicine

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


Locations
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France
Centre Georges Francois Leclerc
Dijon, France, 21079
Clinique Victor Hugo
Le Mans, France, 72000
Chu Limoges
Limoges, France, 87042
Institut Curie
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
Sponsors and Collaborators
Institut Curie
Investigators
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Principal Investigator: PIERGA Jean-Yves, MD Institut Curie
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Institut Curie
ClinicalTrials.gov Identifier: NCT01349842    
Other Study ID Numbers: IC 2009-03
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
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplastic Cells, Circulating
Carcinoma, Ductal, Breast
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasm Metastasis
 Neoplastic Processes
Pathologic Processes
Carcinoma, Ductal
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary