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

Primary Purpose

Breast Cancer Ductal Infiltrating Metastatic

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Blood sampling
Usual clinical and radiological criteria
Sponsored by
Institut Curie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer Ductal Infiltrating Metastatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre Georges Francois Leclerc
  • Clinique Victor Hugo
  • Chu Limoges
  • Institut Curie
  • Hopital Saint Louis
  • Institut Rene Huguenin Curie
  • Institut de Canacerologie de L'Ouest

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Circulating Tumor Cells

Clinical and radiological criteria

Arm Description

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.

Management of chemotherapy according to the usual clinical and radiological criteria adopted by the patient's attending physician.

Outcomes

Primary Outcome Measures

Overall Survival
Overall survival (from date of randomization

Secondary Outcome Measures

Measure of safety and tolerability
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 to progression, to discontinuation of therapy after 3rd line.
Comparison of CTC with usual serum tumour markers
Medico-economical analysis
Estimate the clinical interest, in particular forecast, of the circulating tumoral DNA

Full Information

First Posted
May 5, 2011
Last Updated
March 19, 2019
Sponsor
Institut Curie
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1. Study Identification

Unique Protocol Identification Number
NCT01349842
Brief Title
Circulating Tumor Cells to Guide Chemotherapy for Metastatic Breast Cancer
Acronym
CirCé01
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
March 2, 2010 (Actual)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
November 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Curie

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Ductal Infiltrating Metastatic

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
265 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Circulating Tumor Cells
Arm Type
Experimental
Arm Description
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.
Arm Title
Clinical and radiological criteria
Arm Type
Other
Arm Description
Management of chemotherapy according to the usual clinical and radiological criteria adopted by the patient's attending physician.
Intervention Type
Biological
Intervention Name(s)
Blood sampling
Intervention Description
20ml of patient peripherical blood will be collected
Intervention Type
Other
Intervention Name(s)
Usual clinical and radiological criteria
Intervention Description
Clinical examination, tumoral evaluation
Primary Outcome Measure Information:
Title
Overall Survival
Description
Overall survival (from date of randomization
Time Frame
7 years
Secondary Outcome Measure Information:
Title
Measure of safety and tolerability
Description
A list of the most frequent toxicity was established. The ranks 3 and 4 will be more specificaly collected.
Time Frame
7 years
Title
Improvement of quality of life
Time Frame
7 years
Title
Time to progression, to discontinuation of therapy after 3rd line.
Time Frame
7 years
Title
Comparison of CTC with usual serum tumour markers
Time Frame
7 years
Title
Medico-economical analysis
Time Frame
5 years
Title
Estimate the clinical interest, in particular forecast, of the circulating tumoral DNA
Time Frame
3 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PIERGA Jean-Yves, MD
Organizational Affiliation
Institut Curie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Georges Francois Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Clinique Victor Hugo
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
Chu Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75005
Country
France
Facility Name
Hopital Saint Louis
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Institut Rene Huguenin Curie
City
Saint Cloud
ZIP/Postal Code
92210
Country
France
Facility Name
Institut de Canacerologie de L'Ouest
City
Saint-herblain
ZIP/Postal Code
44805
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33473163
Citation
Cabel L, Berger F, Cottu P, Loirat D, Rampanou A, Brain E, Cyrille S, Bourgeois H, Kiavue N, Deluche E, Ladoire S, Campone M, Pierga JY, Bidard FC. Clinical utility of circulating tumour cell-based monitoring of late-line chemotherapy for metastatic breast cancer: the randomised CirCe01 trial. Br J Cancer. 2021 Mar;124(7):1207-1213. doi: 10.1038/s41416-020-01227-3. Epub 2021 Jan 21.
Results Reference
derived
PubMed Identifier
25700777
Citation
Helissey C, Berger F, Cottu P, Dieras V, Mignot L, Servois V, Bouleuc C, Asselain B, Pelissier S, Vaucher I, Pierga JY, Bidard FC. Circulating tumor cell thresholds and survival scores in advanced metastatic breast cancer: the observational step of the CirCe01 phase III trial. Cancer Lett. 2015 May 1;360(2):213-8. doi: 10.1016/j.canlet.2015.02.010. Epub 2015 Feb 17.
Results Reference
derived

Learn more about this trial

Circulating Tumor Cells to Guide Chemotherapy for Metastatic Breast Cancer

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