Clinical trial NCT04226222: Bringing of PET-TDM FDG in the Determination of the Characteristics of Primary Mammary Tumors TrIple Negatives
Official title: Bringing Semi-quantitative PET-TDM FDG Data and Texture Analysis to Clinical, Histological and Immuno-histochemical Characteristics of Primary Mammary Tumors Triple Negatives
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with triple negative breast cancer operatable from the outset will be

Brief summary: "Triple Negative" breast cancers are a heterogeneous group characterized by the absence of hormone receptors to estrogen, progesterone and the absence of expression or amplification of the HER-2 gene. This type of cancer is associated with an adverse clinical profile with a high risk of early metastatic relapse. Accurate identification of prognostic factors, as well as predictors of therapeutic response, and the contribution of targeted therapies are avenues for improving the management and survival of patients with these cancers. Such an approach requires optimal biological characterization, allowing us to understand the complexity of this group of tumors, and requires multidisciplinary collaboration in clinical trials involving anatomopathology, oncology and morpho-functional imaging.

The investigator's goal is to characterize by innovative methods (anatomo-pathological in particular Of Immunohistochemistry, and morpho-functional imaging (TEP-TDM FDG) semi-quantitative and texture) in a population of Triple Negative Breast Cancer scans better knowledge of this entity that can lead to the development of relevant therapeutic strategies and especially more adapted in the context of precision and personalized medicine.

Detailed description: 120 consecutive patients with "Triple Negative" breast cancers operatable from the outset will be included in the study

* To assess the prognostic value of the texture parameters of PET-TDM FDG on event-free survival at 2 years.
* To assess the prognostic value of standard parameters (clinical, standard histology, conventional imaging), semi-quantitative PET-TDM FDG and innovative Immuno-histochemistry parameters for 2-year event-free survival .
* To assess correlations between continuous PET-TDM FDG texture parameters and Immuno-histochemistry.
* To assess the multivariate prognostic value of standard parameters, PET-TDM FDG imaging parameters and Immuno-histochemistry defined as relevant to 2-year event-free survival .
* Construction of an optimal prognostic nomogram combining independent parameters to isolate different prognostic subgroups.

Eligibility criteria: Inclusion Criteria:

* Patient with biopsy-proven triple-negative breast cancer, newly diagnosed, naïve from any treatment.
* Age - 18.
* Performance Status (PS) : 0 or 1.
* No metastasis on the extension balance.
* Treatment provided immediately by lumpectomy or mastectomy, and accepted by the patient.

Exclusion Criteria:

* Severe illness or comorbidity at risk.
* A history of cancer within 5 years, with the exception of skin carcinomas (other than melanoma) or in-situ cervical carcinomas.
* Patient candidate for neo-adjuvant therapy.

Primary outcomes:
measure: Assess the prognostic value of the texture parameters of PET-TDM FDG on event-free survival at 2 years.
timeFrame: 2 years
Secondary outcomes:
measure: assess the prognostic value of standard parameters (clinical, standard histology, conventional imaging), semi-quantitative PET-TDM FDG and innovative Immunohistochemistry parameters for 2-year event-free survival .
timeFrame: 2 years
measure: To assess the correlations between continuous texture parameters in PET-TDM FDG and Immunohistochemistry.
timeFrame: 2 years
measure: assess the multivariate prognostic value of standard parameters, PET-TDM FDG imaging parameters and Immunohistochemistry defined as relevant to 2-year event-free survival
timeFrame: 2 years
measure: Construction of an optimal prognostic nomogram combining independent parameters to isolate different prognostic subgroups
timeFrame: 2 years
Other outcomes:
Locations:
city: Angers
country: France
facility: Institut de Cancérologie de l'Ouest
city: Saint-Herblain
country: France
facility: Institut de Cancerologie de L'Ouest
Study officials:
affiliation: caroline.rousseau@ico.unicancer.fr
name: Caroline ROUSSEAU, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: