Breast Cancer Ductal Infiltrating MetastaticPhase 3CirCé01NCT01349842
Circulating Tumor Cells to Guide Chemotherapy for Metastatic Breast Cancer
A Phase 3 study testing Blood sampling and Usual clinical and radiological criteria in people with Breast Cancer Ductal Infiltrating Metastatic, run by Institut Curie at 7 sites in France.
Trial summary
Evaluation of the use of Circulating tumour Cells to guide chemotherapy from the 3rd line of chemotherapy for metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Ductal Infiltrating Metastatic
- What is being tested?
- Blood sampling and Usual clinical and radiological criteria
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 265 participants
- Where
- 7 sitesFrance
- Study dates
- 2 Mar 2010to 6 Nov 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Centre Georges Francois Leclerc
Dijon, 21079
Clinique Victor Hugo
Le Mans, 72000
Chu Limoges
Limoges, 87042
Institut Curie
Paris, 75005
Hopital Saint Louis
Paris, 75475
Institut Rene Huguenin Curie
Saint-Cloud, 92210
Institut de Canacerologie de L'Ouest
Saint-Herblain, 44805
About this study
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
Evaluation of the use of Circulating tumour Cells to guide chemotherapy from the 3rd line of chemotherapy for metastatic breast cancer.
Read the 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.
- Being tested
- Blood sampling, Usual clinical and radiological criteria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingBiological
20ml of patient peripherical blood will be collected
Usual clinical and radiological criteriaOther
Clinical examination, tumoral evaluation
| Study group | Role | What they receive |
|---|---|---|
| Circulating Tumor Cells | Experimental | 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. Receives: Biological: Blood sampling |
| Clinical and radiological criteria | Other | Management of chemotherapy according to the usual clinical and radiological criteria adopted by the patient's attending physician. Receives: Other: Usual clinical and radiological criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Overall survival (from date of randomization
Measured: 7 years
Secondary outcomes (6)
Measure of safety and tolerability
A list of the most frequent toxicity was established. The ranks 3 and 4 will be more specificaly collected.
Measured: 7 years
Improvement of quality of life
Measured: 7 years
Time to progression, to discontinuation of therapy after 3rd line.
Measured: 7 years
Comparison of CTC with usual serum tumour markers
Measured: 7 years
Medico-economical analysis
Measured: 5 years
Estimate the clinical interest, in particular forecast, of the circulating tumoral DNA
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2011 (estimated)
- Study start2 Mar 2010
- Primary completionJan 2016
- Study completion6 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer Ductal Infiltrating MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- PIERGA Jean-Yves, MD, Principal investigator, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01349842
- Sponsor's protocol ID
- IC 2009-03
- Acronym
- CirCé01
- Status last verified
- Nov 2025
- First submitted
- 5 May 2011
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 33473163Helissey 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.
PubMed 25700777
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01349842
- Acronym / sponsor ID
- CirCé01 / IC 2009-03
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- 2 Mar 2010 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- 6 Nov 2018 (actual)
- First posted
- 9 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Circulating Tumor Cells | Experimental | Biological: Blood samplingCentralized 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. |
| Clinical and radiological criteria | Other | Other: Usual clinical and radiological criteriaManagement of chemotherapy according to the usual clinical and radiological criteria adopted by the patient's attending physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampling20ml of patient peripherical blood will be collected | Biological | Circulating Tumor Cells |
| Usual clinical and radiological criteriaClinical examination, tumoral evaluation | Other | Clinical and radiological criteria |
Primary outcome
Overall Survival
Time frame: 7 years
Overall survival (from date of randomization
6 secondary outcomes
Measure of safety and tolerability
Time frame: 7 years
Improvement of quality of life
Time frame: 7 years
Time to progression, to discontinuation of therapy after 3rd line.
Time frame: 7 years
Comparison of CTC with usual serum tumour markers
Time frame: 7 years
Medico-economical analysis
Time frame: 5 years
Estimate the clinical interest, in particular forecast, of the circulating tumoral DNA
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Background: PubMed 33473163Cabel 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 publication: PubMed 25700777Helissey 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
PIERGA Jean-Yves, MD principal investigator
Institut Curie
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Blood sampling and Usual clinical and radiological criteria in people with Breast Cancer Ductal Infiltrating Metastatic, run by Institut Curie at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01349842, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.