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

  • STATUS
    Recruiting
  • End date
    Oct 30, 2023
  • participants needed
    120
  • sponsor
    Institut Cancerologie de l'Ouest
Updated on 24 February 2022
estrogen
progesterone
metastasis
immunohistochemistry
triple negative breast cancer
erbb2
mastectomy
lumpectomy

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.

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.

Details
Condition Breast Cancer
Treatment TEP-TDM FDG
Clinical Study IdentifierNCT04226222
SponsorInstitut Cancerologie de l'Ouest
Last Modified on24 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patient with biopsy-proven triple-negative breast cancer, newly diagnosed, nave 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
Clear my responses

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