Triple Negative Breast CancerINSTIGONCT04438681
Evaluation of a Plasma Protein Profile as a Predictive Biomarker for Metastatic Relapse in Triple Negative Breast Cancer Patients
An observational study of Triple Negative Breast Cancer, run by Centre Jean Perrin at 1 site in France.
Trial summary
The INSTIGO study aims to assess a plasma protein profile at different stages of patient follow-up as a predictive factor of metastatic recurrence in triple negative breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Triple Negative Breast Cancer
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 27 Nov 2020to 9 Nov 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Women diagnosed with primitive, non-metastatic, histologically proved, triple negative breast cancer
Who may be able to join
- Female
- Age > 18 years
- Diagnosed with primitive, non-metastatic, histologically proved, triple negative breast cancer
- Patient able to understand the French language
- Patient affiliated to social security
- Obtaining signed written consent
Who cannot join
- Persons deprived of their freedom or under guardianship or incapable of giving consent
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: INSTIGO Trial: Evaluation of a Plasma Protein Profile as a Predictive Biomarker for Metastatic Relapse in Triple Negative Breast Cancer Patients
The INSTIGO study aims to assess a plasma protein profile at different stages of patient follow-up as a predictive factor of metastatic recurrence in triple negative breast cancer. It also aims to look at other potential biomarkers of metastatic relapse such as Tumor-infiltrating Lymphocytes, circulating tumor DNA, figurative elements in blood, or a tumor RNA signature.
Read the detailed description
The investigators propose to carry out a study that measures the concentrations of a set of plasma proteins in order to assess their ability to predict metastatic relapse of triple negative breast cancer. A plasma protein profile could be an interesting biomarker since it is easily accessible and quantifiable.
The investigators also propose to search relation between metastatic relapse in TNBC and other biomarkers or potential biomarkers such as Tumor-infiltrating Lymphocytes (TILs), figurative blood components and circulating tumour DNA (ctDNA).
Finally, they also want to validate a TNBC RNA signature, established at Jean PERRIN Center, by analyzing the RNA expression of 8 genes.
Before treatment begins, the patient will take an initial blood sample. A second blood sample will be taken on the day of the first surgery or the day of the surgery post chemotherapy. A third blood sample will be done on the day of the beginning of the radiotherapy. A 4th and a 5th blood sample will be done at 6 months and 1 year respectively after the end of the radiotherapy. A part of these blood samples will be used for the quantification of circulating proteins, for the determination of the blood's figurative elements and for the quantification of circulating tumour DNA.
- Conditions
- Triple Negative Breast Cancer
- Medical subject headings
- Triple Negative Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification at diagnosis of a plasma protein profile predictive of metastatic relapse in patients with triple-negative breast cancer (TNBC)
- Plasma concentrations of a set of proteins at diagnosis (measured in g/L)
Measured: 8 years
Identification at diagnosis of a plasma protein profile predictive of metastatic relapse in patients with triple-negative breast cancer (TNBC)
- Time to metastatic relapse
Measured: 8 years
Secondary outcomes (12)
Identification of a plasma protein profile predictive of metastatic relapse in patients with TNBC : on the day of primary surgery or post-chemotherapy surgery, the day the radiotherapy begins, at 6 months after radiotherapy and one year post-radiotherapy
- Plasma concentrations of a set of proteins (measured in g/L)
Measured: 8 years
Identification of a plasma protein profile predictive of metastatic relapse in patients with TNBC : on the day of primary surgery or post-chemotherapy surgery, the day the radiotherapy begins, at 6 months after radiotherapy and one year post-radiotherapy
- Time to metastatic relapse
Measured: 8 years
Identification of a characteristic plasma protein profile at the time of metastatic relapse
- Plasma concentrations of a set of proteins (measured in g/L)
Measured: 8 years
Evaluation of the relationship between the rate of tumour lymphocyte infiltration at diagnosis and metastatic relapse.
- Tumor lymphocyte infiltration rate before treatment
Measured: 8 years
Evaluation of the relationship between ctDNA plasma levels and metastatic disease relapse
- Measurement of plasma ctDNA level
Measured: 8 years
Evaluation of the relationship between ctDNA plasma levels and metastatic disease relapse
- Time to metastatic relapse
Measured: 8 years
Evaluation of the relationship between Platelet-to-lymphocyte Ratio (PLR) and Neutrophil-to-lymphocyte Ratio (NLR) and metastatic relapse
- The values of NLR and PLR at diagnosis (no Unit)
Measured: 8 years
Evaluation of a metastatic relapse prognostic RNA signature for triple negative breast tumors
- RNA expression of 6 genes of interest
Measured: 8 years
Identification at diagnosis of a plasma protein profile predictive of response to neoadjuvant chemotherapy
- Plasma concentrations of a set of proteins at diagnosis
Measured: 3 years and 6 months
Identification at diagnosis of a plasma protein profile predictive of response to neoadjuvant chemotherapy
- Histological response according to the Sataloff classification
Measured: 3 years and 6 months
Evaluation of the relationship between the rate of tumour lymphocyte infiltration at diagnosis and the response to a neoadjuvant chemotherapy .
- Tumor lymphocyte infiltration rate before treatment
Measured: 3 years and 6 months
Evaluation of the relationship between Platelet-to-lymphocyte Ratio (PLR) and Neutrophil-to-lymphocyte Ratio (NLR) and the response to a neoadjuvant chemotherapy
- The values of NLR and PLR at diagnosis
- The values of NLR and PLR after neoadjuvant chemotherapy
Measured: 3 years and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start27 Nov 2020
- Primary completion9 Nov 2026 (estimated)
- Study completion9 Nov 2029 (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 Triple Negative 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Jean Perrin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04438681
- Sponsor's protocol ID
- 2020-A01423-36
- Acronym
- INSTIGO
- Status last verified
- Nov 2025
- First submitted
- 15 Jun 2020
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pinard C, Ginzac A, Molnar I, Veyssiere H, Bidet Y, Sapin V, Durif J, Abrial C, Penault-Llorca F, Durando X, Radosevic-Robin N. Identification of serum proteins associated with response of triple-negative breast cancer to neoadjuvant chemotherapy: preliminary results from the INSTIGO trial. Clin Proteomics. 2025 Dec 29;22(1):50. doi: 10.1186/s12014-025-09574-0.
PubMed 41462069Veyssiere H, Lusho S, Molnar I, Kossai M, Bernadach M, Abrial C, Bidet Y, Radosevic-Robin N, Durando X. INSTIGO Trial: Evaluation of a Plasma Protein Profile as a Predictive Biomarker for Metastatic Relapse of Triple Negative Breast Cancer. Front Oncol. 2021 Jun 25;11:653370. doi: 10.3389/fonc.2021.653370. eCollection 2021.
PubMed 34249690
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INSTIGO Trial: Evaluation of a Plasma Protein Profile as a Predictive Biomarker for Metastatic Relapse in Triple Negative Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT04438681
- Acronym / sponsor ID
- INSTIGO / 2020-A01423-36
- Conditions
- Triple Negative Breast Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Centre Jean PerrinUniversity, hospital or other
- Study start
- 27 Nov 2020 (actual)
- Primary completion
- 9 Nov 2026 (estimated)
- Study completion
- 9 Nov 2029 (estimated)
- First posted
- 19 Jun 2020 (actual)
- 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 INSTIGO study aims to assess a plasma protein profile at different stages of patient follow-up as a predictive factor of metastatic recurrence in triple negative breast cancer. It also aims to look at other potential biomarkers of metastatic relapse such as Tumor-infiltrating Lymphocytes, circulating tumor DNA, figurative elements in blood, or a tumor RNA signature.
Detailed description
The investigators propose to carry out a study that measures the concentrations of a set of plasma proteins in order to assess their ability to predict metastatic relapse of triple negative breast cancer. A plasma protein profile could be an interesting biomarker since it is easily accessible and quantifiable.
The investigators also propose to search relation between metastatic relapse in TNBC and other biomarkers or potential biomarkers such as Tumor-infiltrating Lymphocytes (TILs), figurative blood components and circulating tumour DNA (ctDNA).
Finally, they also want to validate a TNBC RNA signature, established at Jean PERRIN Center, by analyzing the RNA expression of 8 genes.
Before treatment begins, the patient will take an initial blood sample. A second blood sample will be taken on the day of the first surgery or the day of the surgery post chemotherapy. A third blood sample will be done on the day of the beginning of the radiotherapy. A 4th and a 5th blood sample will be done at 6 months and 1 year respectively after the end of the radiotherapy. A part of these blood samples will be used for the quantification of circulating proteins, for the determination of the blood's figurative elements and for the quantification of circulating tumour DNA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women diagnosed with primitive, non-metastatic, histologically proved, triple negative breast cancer
Key inclusion criteria (6 listed)
- Female
- Age > 18 years
- Diagnosed with primitive, non-metastatic, histologically proved, triple negative breast cancer
- Patient able to understand the French language
- Patient affiliated to social security
Key exclusion criteria (2 listed)
- Persons deprived of their freedom or under guardianship or incapable of giving consent
- Refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification at diagnosis of a plasma protein profile predictive of metastatic relapse in patients with triple-negative breast cancer (TNBC)
Time frame: 8 years
- Plasma concentrations of a set of proteins at diagnosis (measured in g/L)
Identification at diagnosis of a plasma protein profile predictive of metastatic relapse in patients with triple-negative breast cancer (TNBC)
Time frame: 8 years
- Time to metastatic relapse
12 secondary outcomes
Identification of a plasma protein profile predictive of metastatic relapse in patients with TNBC : on the day of primary surgery or post-chemotherapy surgery, the day the radiotherapy begins, at 6 months after radiotherapy and one year post-radiotherapy
Time frame: 8 years
Identification of a plasma protein profile predictive of metastatic relapse in patients with TNBC : on the day of primary surgery or post-chemotherapy surgery, the day the radiotherapy begins, at 6 months after radiotherapy and one year post-radiotherapy
Time frame: 8 years
Identification of a characteristic plasma protein profile at the time of metastatic relapse
Time frame: 8 years
Evaluation of the relationship between the rate of tumour lymphocyte infiltration at diagnosis and metastatic relapse.
Time frame: 8 years
Evaluation of the relationship between ctDNA plasma levels and metastatic disease relapse
Time frame: 8 years
Evaluation of the relationship between ctDNA plasma levels and metastatic disease relapse
Time frame: 8 years
Evaluation of the relationship between Platelet-to-lymphocyte Ratio (PLR) and Neutrophil-to-lymphocyte Ratio (NLR) and metastatic relapse
Time frame: 8 years
Evaluation of a metastatic relapse prognostic RNA signature for triple negative breast tumors
Time frame: 8 years
Identification at diagnosis of a plasma protein profile predictive of response to neoadjuvant chemotherapy
Time frame: 3 years and 6 months
Identification at diagnosis of a plasma protein profile predictive of response to neoadjuvant chemotherapy
Time frame: 3 years and 6 months
Evaluation of the relationship between the rate of tumour lymphocyte infiltration at diagnosis and the response to a neoadjuvant chemotherapy .
Time frame: 3 years and 6 months
Evaluation of the relationship between Platelet-to-lymphocyte Ratio (PLR) and Neutrophil-to-lymphocyte Ratio (NLR) and the response to a neoadjuvant chemotherapy
Time frame: 3 years and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Derived from this study: PubMed 41462069Pinard C, Ginzac A, Molnar I, Veyssiere H, Bidet Y, Sapin V, Durif J, Abrial C, Penault-Llorca F, Durando X, Radosevic-Robin N. Identification of serum proteins associated with response of triple-negative breast cancer to neoadjuvant chemotherapy: preliminary results from the INSTIGO trial. Clin Proteomics. 2025 Dec 29;22(1):50. doi: 10.1186/s12014-025-09574-0.
- Derived from this study: PubMed 34249690Veyssiere H, Lusho S, Molnar I, Kossai M, Bernadach M, Abrial C, Bidet Y, Radosevic-Robin N, Durando X. INSTIGO Trial: Evaluation of a Plasma Protein Profile as a Predictive Biomarker for Metastatic Relapse of Triple Negative Breast Cancer. Front Oncol. 2021 Jun 25;11:653370. doi: 10.3389/fonc.2021.653370. eCollection 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Triple Negative Breast Cancer, run by Centre Jean Perrin at 1 site 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 6 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Identification at diagnosis of a plasma protein profile predictive of metastatic relapse in patients with triple-negative breast cancer (TNBC) (time frame: 8 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 NCT04438681, 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 4 Dec 2025.