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

Active, not recruiting

• Conditions: Breast Cancer
• Interventions: Diagnostic Test: TEP-TDM FDG

• Registration Number: NCT04226222
• Lead Sponsor: Institut Cancerologie de l'Ouest

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.

Study Timeline

• Study Start: 2019-11-05
• Study First Submitted: 2020-01-09
• Study First Submitted QC: 2020-01-10
• Study First Posted: 2020-01-13
• Status Verified: 2022-08
• Primary Completion: 2022-10-22
• Last Update Submitted: 2023-02-20
• Last Update Posted: 2023-02-21
• Study Completion: 2024-10-22

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 132

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Triple negative Breast Cancer	TEP-TDM FDG	Triple Negative Breast Cancer operatable from the outset

Primary Outcome Measures

Name	Time	Method
Assess the prognostic value of the texture parameters of PET-TDM FDG on event-free survival at 2 years.	2 years	The 2-year event-free survival rate based on the texture parameters of the PET-TDM FDG.; Event free survival is the duration between the date of diagnosis and the date of the first event (relapse, death) or the date of the last news without event.

Secondary Outcome Measures

Name	Time	Method
Construction of an optimal prognostic nomogram combining independent parameters to isolate different prognostic subgroups	2 years	2-year event-free survival rate depending on the risk groups determined from the nomogram score.
assess the multivariate prognostic value of standard parameters, PET-TDM FDG imaging parameters and Immunohistochemistry defined as relevant to 2-year event-free survival	2 years	2-year event-free survival rate in multivariate analysis according to standard parameters, PET-TDM FDG imaging parameters and Immunohistochemistry.
To assess the correlations between continuous texture parameters in PET-TDM FDG and Immunohistochemistry.	2 years	Correlation coefficients between the continuous criteria of the FDG PET texture parameters and those of the Immunohistochemistry.
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 .	2 years	2-year event-free survival rate based on univariate analysis of standard, semi-quantitative parameters of PET-TDM FDG and innovative Immunohistochemistry parameters.

Trial Locations

Locations (2)

Institut de Cancérologie de l'Ouest; 🇫🇷 Angers, France

Institut de Cancerologie de L'Ouest; 🇫🇷 Saint-Herblain, France