Bringing of PET-TDM FDG in the Determination of the Characteristics of Primary Mammary Tumors TrIple Negatives (FICTION)

Institut Cancerologie de l'Ouest

Status: Active, not recruiting

Conditions: Breast Cancer

Treatments: Diagnostic Test: TEP-TDM FDG

Study type: Observational

Funder types: Other

Identifiers

NCT04226222

ICO-2019-03

Details and patient eligibility

About

"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.

Full 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.

Enrollment: 132 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

132 participants in 1 patient group

Triple negative Breast Cancer

Description:

Triple Negative Breast Cancer operatable from the outset

Treatment:

Diagnostic Test: TEP-TDM FDG