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

November 19, 2025 updated by: Institut Curie

CirCe01 Study: Evaluation of the Use of Circulating Tumour Cells to Guide Chemotherapy From the 3rd Line of Chemotherapy for Metastatic Breast Cancer

Evaluation of the use of Circulating tumour Cells to guide chemotherapy from the 3rd line of chemotherapy for metastatic breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

265

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21079
        • Centre Georges Francois Leclerc
      • Le Mans, France, 72000
        • Clinique Victor Hugo
      • Limoges, France, 87042
        • CHU Limoges
      • Paris, France, 75475
        • Hopital Saint Louis
      • Paris, France, 75005
        • Institut Curie
      • Saint-Cloud, France, 92210
        • Institut Rene Huguenin Curie
      • Saint-Herblain, France, 44805
        • Institut de Canacerologie de L'Ouest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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
Other: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Curie

Investigators

  • Principal Investigator: PIERGA Jean-Yves, MD, Institut Curie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2010

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

November 6, 2018

Study Registration Dates

First Submitted

May 5, 2011

First Submitted That Met QC Criteria

May 6, 2011

First Posted (Estimated)

May 9, 2011

Study Record Updates

Last Update Posted (Estimated)

November 24, 2025

Last Update Submitted That Met QC Criteria

November 19, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IC 2009-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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