Clinical trial NCT04438681: Evaluation of a Plasma Protein Profile as a Predictive Biomarker for Metastatic Relapse in Triple Negative Breast Cancer Patients
Official title: INSTIGO Trial: Evaluation of a Plasma Protein Profile as a Predictive Biomarker for Metastatic Relapse in Triple Negative Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Triple Negative Breast Cancer
Lead sponsor: Centre Jean Perrin
Sponsor class: OTHER
First posted: 2020-06-19
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women diagnosed with primitive, non-metastatic, histologically proved, triple negative breast cancer

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Persons deprived of their freedom or under guardianship or incapable of giving consent
* Refusal to participate

Primary outcomes:
measure: Identification at diagnosis of a plasma protein profile predictive of metastatic relapse in patients with triple-negative breast cancer (TNBC)
timeFrame: 8 years
measure: Identification at diagnosis of a plasma protein profile predictive of metastatic relapse in patients with triple-negative breast cancer (TNBC)
timeFrame: 8 years
Secondary outcomes:
measure: 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
timeFrame: 8 years
measure: 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
timeFrame: 8 years
measure: Identification of a characteristic plasma protein profile at the time of metastatic relapse
timeFrame: 8 years
measure: Evaluation of the relationship between the rate of tumour lymphocyte infiltration at diagnosis and metastatic relapse.
timeFrame: 8 years
measure: Evaluation of the relationship between ctDNA plasma levels and metastatic disease relapse
timeFrame: 8 years
measure: Evaluation of the relationship between ctDNA plasma levels and metastatic disease relapse
timeFrame: 8 years
measure: Evaluation of the relationship between Platelet-to-lymphocyte Ratio (PLR) and Neutrophil-to-lymphocyte Ratio (NLR) and metastatic relapse
timeFrame: 8 years
measure: Evaluation of a metastatic relapse prognostic RNA signature for triple negative breast tumors
timeFrame: 8 years
measure: Identification at diagnosis of a plasma protein profile predictive of response to neoadjuvant chemotherapy
timeFrame: 3 years and 6 months
measure: Identification at diagnosis of a plasma protein profile predictive of response to neoadjuvant chemotherapy
timeFrame: 3 years and 6 months
measure: Evaluation of the relationship between the rate of tumour lymphocyte infiltration at diagnosis and the response to a neoadjuvant chemotherapy .
timeFrame: 3 years and 6 months
measure: Evaluation of the relationship between Platelet-to-lymphocyte Ratio (PLR) and Neutrophil-to-lymphocyte Ratio (NLR) and the response to a neoadjuvant chemotherapy
timeFrame: 3 years and 6 months
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Centre Jean PERRIN
Study officials:
References:
citation: Veyssiere 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.