Ductal Infiltrating Metastatic Breast CancerPhase 3NCT01710605
Medico-economic Interest of Taking Into Account Circulating Tumor Cells (CTC) to Determine the Kind of First Line Treatment for Metastatic, Hormone-receptors Positive, Breast Cancers
A Phase 3 study testing Circulating tumor cells counting at baseline in people with Ductal Infiltrating Metastatic Breast Cancer and Hormone-receptors Positive Breast Cancer, run by Institut Curie at 17 sites in France.
Trial summary
The STIC CTC study is a randomized trial to evaluate the medico-economic interest of taking into account circulating tumor cells (CTC) to determine the kind of first line treatment for metastatic, hormone-receptors positive, breast cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ductal Infiltrating Metastatic Breast Cancer, Hormone-receptors Positive Breast Cancer
- What is being tested?
- Circulating tumor cells counting at baseline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 17 sitesFrance
- Study dates
- Feb 2012to Sep 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with metastatic ductal adenocarcinoma breast cancer
- 18 years old or more
- Hormone receptors positive breast cancer (ER+ and/or PR+) on the last pathological analysis available.
- Acceptable patient's clinical situation compatible with chemotherapy or hormonotherapy administration
- PS <4
- Life expectancy > 3 months
- Evidence of measurable or evaluable disease (RECIST 1.1 criteria)in the 28 days before selection
- Information of the patient and signature of the informed consent form
Who cannot join
- Patient treated by chemotherapy or hormonotherapy for their metastatic disease (treatment failure under adjuvant hormonotherapy are accepted)
- Her2 positive breast cancer
- History of other stage II or III cancer in the 5 years. History of other metastatic cancer (whatever the time between the two cancers).
- 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
17 sites in 1 country.
17 sites in 1 country
France17 sites
Centre François Baclesse
Caen, 14076
Centre Georges Francois Leclerc
Dijon, 21079
Clinique Victor Hugo
Le Mans, 72000
Centre Leon Berard
Lyon, 69373
Institut Paoli Calmettes
Marseille, 13009
Chu Montpellier
Montpellier, 34000
Institut régional du Cancer de Montpellier
Montpellier, 34298
Centre Azureen de Cancerologie
Mougins, 06250
Centre Antoine Lacassagne
Nice, 06189
Institut Curie
Paris, 75005
Hopital SAINT-LOUIS
Paris, 75010
Hopital Europeen Georges Pompidou
Paris, 75015
Hopital Tenon
Paris, 75020
Institut Curie - Hopital Rene Huguenin
Saint-Cloud, 92210
Institut de Cancerologie de L'Ouest - Rene Gauducheau
Saint-Herblain, 44805
Institut Claudius Regaud
Toulouse, 31052
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54500
About this study
Official title: Randomized Trial to Evaluate the Medico-economic Interest of Taking Into Account Circulating Tumor Cells (CTC) to Determine the Kind of First Line Treatment for Metastatic, Hormone-receptors Positive, Breast Cancers.
The STIC CTC study is a randomized trial to evaluate the medico-economic interest of taking into account circulating tumor cells (CTC) to determine the kind of first line treatment for metastatic, hormone-receptors positive, breast cancers. In the standard arm, the kind of treatment will be decided by clinicians, taking into account the criteria usually used in this setting. In the CTC arm, the type of treatment will be decided by CTC count: hormone-therapy if <5CTC/7.5mll (CellSearch technique) or chemotherapy if =5. The main medical objective is to demonstrate the non-inferiority of the CTC-based strategy for the progression-free survival: 994 patients are needed, and will be accrued in French cancer centers. Secondary clinical objectives are to compare toxicity, quality of life and overall survival between the two arms. The medico-economic study will compare cost per progression-free life years gained of the two strategies. The financial impact of centralized (one platform) vs decentralized (several platforms) CTC testing will be evaluated.
- Being tested
- Circulating tumor cells counting at baseline
- Keywords
- Circulating tumor cells, Breast Cancer, Hormone-receptors positive
- Medical subject headings
- Neoplastic Cells, Circulating, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circulating tumor cells counting at baselineBiological
20 ml blood sample collected before randomization
| Study group | Role | What they receive |
|---|---|---|
| Standard | Active comparator | Treatment choices (hormonotherapy or chemotherapy) are done according to standard of each center based on clinical, radiological and biological information. Receives: Biological: Circulating tumor cells counting at baseline |
| Circulating Tumor Cells | Experimental | Treatment choices (hormonotherapy or chemotherapy) are done according to the number of CTC / 7.5 ml of blood at baseline :
If <5 CTC : Hormonotherapy If 5 or more CTC : chemotherapy Receives: Biological: Circulating tumor cells counting at baseline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival evaluation
According to RECIST 1.1 criteria
Measured: 2 years
Economic evaluation
Economic impact of the strategy will be evaluated (standard treatment choice vs CTC based treatment choice)
Measured: 2 years
Secondary outcomes (3)
Assessing patient quality of life
QLQC30 and BR23 individual questionaries
Measured: 2 years
Evaluation of treatment safety according to NCI-CTCAEv4.03
Evaluation of both chemotherapy and hormone therapy will be recorded in CRFs whatever the randomization.
Measured: 2 years
Overall survival evaluation
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2012 (estimated)
- Study startFeb 2012
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (estimated)
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 Ductal Infiltrating Metastatic Breast CancerStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Yves Pierga, Principal investigator, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01710605
- Sponsor's protocol ID
- IC 2011-09
- Status last verified
- Apr 2018
- First submitted
- 10 Aug 2012
- Last updated
- 9 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Bidard FC, Kiavue N, Jacot W, Bachelot T, Dureau S, Bourgeois H, Goncalves A, Brain E, Ladoire S, Dalenc F, Gligorov J, Teixeira L, Emile G, Ferrero JM, Loirat D, Cabel L, Kadi A, Dieras V, Alix-Panabieres C, Pierga JY. Overall Survival With Circulating Tumor Cell Count-Driven Choice of Therapy in Advanced Breast Cancer: A Randomized Trial. J Clin Oncol. 2024 Feb 1;42(4):383-389. doi: 10.1200/JCO.23.00456. Epub 2023 Nov 6.
PubMed 37931185Bidard FC, Jacot W, Kiavue N, Dureau S, Kadi A, Brain E, Bachelot T, Bourgeois H, Goncalves A, Ladoire S, Naman H, Dalenc F, Gligorov J, Espie M, Emile G, Ferrero JM, Loirat D, Frank S, Cabel L, Dieras V, Cayrefourcq L, Simondi C, Berger F, Alix-Panabieres C, Pierga JY. Efficacy of Circulating Tumor Cell Count-Driven vs Clinician-Driven First-line Therapy Choice in Hormone Receptor-Positive, ERBB2-Negative Metastatic Breast Cancer: The STIC CTC Randomized Clinical Trial. JAMA Oncol. 2021 Jan 1;7(1):34-41. doi: 10.1001/jamaoncol.2020.5660.
PubMed 33151266
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial to Evaluate the Medico-economic Interest of Taking Into Account Circulating Tumor Cells (CTC) to Determine the Kind of First Line Treatment for Metastatic, Hormone-receptors Positive, Breast Cancers.
- ClinicalTrials.gov ID
- NCT01710605
- Acronym / sponsor ID
- IC 2011-09
- Keywords
- Circulating tumor cells, Breast Cancer, Hormone-receptors positive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 19 Oct 2012 (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.
The STIC CTC study is a randomized trial to evaluate the medico-economic interest of taking into account circulating tumor cells (CTC) to determine the kind of first line treatment for metastatic, hormone-receptors positive, breast cancers. In the standard arm, the kind of treatment will be decided by clinicians, taking into account the criteria usually used in this setting. In the CTC arm, the type of treatment will be decided by CTC count: hormone-therapy if <5CTC/7.5mll (CellSearch technique) or chemotherapy if =5. The main medical objective is to demonstrate the non-inferiority of the CTC-based strategy for the progression-free survival: 994 patients are needed, and will be accrued in French cancer centers. Secondary clinical objectives are to compare toxicity, quality of life and overall survival between the two arms. The medico-economic study will compare cost per progression-free life years gained of the two strategies. The financial impact of centralized (one platform) vs decentralized (several platforms) CTC testing will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard | Active comparator | Biological: Circulating tumor cells counting at baselineTreatment choices (hormonotherapy or chemotherapy) are done according to standard of each center based on clinical, radiological and biological information. |
| Circulating Tumor Cells | Experimental | Biological: Circulating tumor cells counting at baselineTreatment choices (hormonotherapy or chemotherapy) are done according to the number of CTC / 7.5 ml of blood at baseline : If <5 CTC : Hormonotherapy If 5 or more CTC : chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Women with metastatic ductal adenocarcinoma breast cancer
- 18 years old or more
- Hormone receptors positive breast cancer (ER+ and/or PR+) on the last pathological analysis available.
- Acceptable patient's clinical situation compatible with chemotherapy or hormonotherapy administration
- PS <4
Key exclusion criteria (5 listed)
- Patient treated by chemotherapy or hormonotherapy for their metastatic disease (treatment failure under adjuvant hormonotherapy are accepted)
- Her2 positive breast cancer
- History of other stage II or III cancer in the 5 years. History of other metastatic cancer (whatever the time between the two cancers).
- 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.
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 |
|---|---|---|
| Circulating tumor cells counting at baseline20 ml blood sample collected before randomization | Biological | Circulating Tumor Cells, Standard |
Primary outcome
Progression free survival evaluation
Time frame: 2 years
According to RECIST 1.1 criteria
Economic evaluation
Time frame: 2 years
Economic impact of the strategy will be evaluated (standard treatment choice vs CTC based treatment choice)
3 secondary outcomes
Assessing patient quality of life
Time frame: 2 years
Evaluation of treatment safety according to NCI-CTCAEv4.03
Time frame: 2 years
Overall survival evaluation
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2018.
- Derived from this study: PubMed 37931185Bidard FC, Kiavue N, Jacot W, Bachelot T, Dureau S, Bourgeois H, Goncalves A, Brain E, Ladoire S, Dalenc F, Gligorov J, Teixeira L, Emile G, Ferrero JM, Loirat D, Cabel L, Kadi A, Dieras V, Alix-Panabieres C, Pierga JY. Overall Survival With Circulating Tumor Cell Count-Driven Choice of Therapy in Advanced Breast Cancer: A Randomized Trial. J Clin Oncol. 2024 Feb 1;42(4):383-389. doi: 10.1200/JCO.23.00456. Epub 2023 Nov 6.
- Derived from this study: PubMed 33151266Bidard FC, Jacot W, Kiavue N, Dureau S, Kadi A, Brain E, Bachelot T, Bourgeois H, Goncalves A, Ladoire S, Naman H, Dalenc F, Gligorov J, Espie M, Emile G, Ferrero JM, Loirat D, Frank S, Cabel L, Dieras V, Cayrefourcq L, Simondi C, Berger F, Alix-Panabieres C, Pierga JY. Efficacy of Circulating Tumor Cell Count-Driven vs Clinician-Driven First-line Therapy Choice in Hormone Receptor-Positive, ERBB2-Negative Metastatic Breast Cancer: The STIC CTC Randomized Clinical Trial. JAMA Oncol. 2021 Jan 1;7(1):34-41. doi: 10.1001/jamaoncol.2020.5660.
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.
Jean-Yves Pierga principal investigator
Institut Curie
17 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 Circulating tumor cells counting at baseline in people with Ductal Infiltrating Metastatic Breast Cancer and Hormone-receptors Positive Breast Cancer, run by Institut Curie at 17 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 8 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 9 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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?
Results are not available in the source record.
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?
Progression free survival evaluation (time frame: 2 years). The study lists 2 primary outcomes in all. 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 NCT01710605, 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 9 Apr 2018.